At Just. you will find purpose and enjoyment in solving important challenges in an environment built on respect, community, trust, collaboration, incredibly cool science, and amazing feats of engineering with exceptional people.

 With the highly experienced and innovative staff
we are assembling at Just,
we have a real and significant opportunity 
to improve
worldwide access to many important biotherapeutics.
– Dean Pettit

available positions

Administrative Coordinator  | Just. – Seattle, WA |

Just-Evotec Biologics is seeking an Administrative Coordinator to join a fast-paced, collaborative and multi-disciplinary team for the advancement of low-cost biotherapeutics manufacturing. This position will be responsible for administrative and operational duties to support members of the Just Leadership Team and Business Operations.

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Responsibilities:

  • Proactively manage calendar and scheduling for internal and external meetings, conferences and professional engagements for leadership team with an understanding of business priorities
  • Organize domestic and international travel arrangements and prepare itineraries; anticipate and proactively handle last minute adjustments or changes
  • Prepare and process expense reports with attention to accuracy, timelines and compliance with Corporate policy requirements; track payments and troubleshoot issues
  • Track and route for signature legal documents and agreements for corporate development and supply chain management
  • Assist with accounting and financial transactions
  • Assist in planning and coordinating logistics for small to large scale onsite or virtual meetings and events; logistics include conference room scheduling, audio visual set-up, catering (as needed) and preparing agendas
  • Compose and prepare correspondences, documents, presentation materials, meeting minutes and reports for executive team
  • Coordinate and schedule candidate interviews

Qualification and Requirements:

  • BA preferred, or combination of education and experience
  • Minimum of five, preferably seven to ten years of experience supporting executive and management teams
  • Motivated self-starter who can work independently with minimal supervision in a fast-paced and multidisciplinary environment
  • Ability to prioritize work based on business need
  • Proficient with various virtual meeting platforms, such as WebEx, Google Hangouts Meet, and Skype
  • Proactive with excellent interpersonal skills
  • Highly proficient in MS Office Applications (Excel, PowerPoint, Word) and GSuite for Business Software  (Gmail, GCalendar, Drive)
  • Strong organizational and project coordination skills with a willingness to take initiative
  • Displays professionalism in all internal and external endeavors
  • Successful experience indicating attention to detail, quality of work, ability to work independently and in teams, strong follow-up skills, and ability to manage multiple projects simultaneously
  • Results driven with strong attention to detail

About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

Administrative Coordinator

please send resume and cover letter

Associate Scientist, Drug Product  | Just. – Seattle, WA |

Just-Evotec Biologics is seeking a motivated and creative Associate Scientist, who desire a significant opportunity to improve worldwide access to biotherapeutics.  We are looking for team members to join a fast-paced, collaborative, and multidisciplinary group to support development projects ranging from discovery to product formulation and stability development for low-cost biotherapeutic manufacturing.

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Responsibilities:

  • Support scientific staff with various protein characterization methods including SE-HPLC, sub-visible particle analysis (HIAC and Flowcam), protein concentration (UV-Vis), pH, osmo, buffer exchange and viscosity.
  • Execution of established high throughput biophysical methods
  • Perform lab maintenance tasks will include buffer preparation, tracking/ordering consumables, and shipping/receiving samples.

Requirements:

  • BS in Chemistry, Biochemistry, Molecular and Cellular Biology, Chemical Engineering, Bioengineering or related field and 0-3 years experience

Preferred Qualifications:

  • Strong understanding of protein characterization techniques
  • Experience working in a laboratory setting
  • Attention to detail and demonstrating initiative for support needs are highly desired skills
  • Strong written and verbal communications skills and works well independently and in teams
  • Proficiency with Microsoft Office apps (Word, PowerPoint, Excel)

About Just-Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just-Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

Associate Scientist, Drug Product

please send resume and cover letter

Associate Scientist, Molecular Biologist/Protein Bioengineer  | Just. – Seattle, WA |

Just.Bio is seeking a motivated and creative Associate Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics. We are looking for a member to join a fast-paced, collaborative, and multidisciplinary group to support molecular design and antibody discovery for low-cost biotherapeutic manufacturing. The successful candidates will have some experience in one or more of molecular biology, protein expression, protein biochemistry, cell culture, or bioinformatics. Experience with high throughput methodologies, robot utilization, programming, and computational biology is a plus. The ideal candidate will have strong written and verbal communication skills and work well independently and in teams. This position may include the opportunity to rotate through different functional areas to gain experience in different techniques and disciplines.

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Examples of Potential Responsibilities:

  • Design, assemble, purify and sequence expression vectors for mammalian, yeast, and E. coli protein reagents and biotherapeutics
  • Perform prokaryotic and eukaryotic transfection methodologies, monitor progress and analyze results
  • Utilize high-throughput instrumentation and methods to generate data for the Data Science team
  • Utilize LIMS, bioinformatics, statistical software and computational platforms to register, analyze, and design molecular entities
  • Work with members across functions on technology development to reduce the cost and improve the efficiency, speed, and capacity of molecular design, modeling, and biotherapeutic candidate development

Requirements:

  • BS/MS in Chemistry, Biochemistry, Molecular and Cellular Biology, Chemical Engineering, Bioengineering or related field and 0-3 years experience
  • Experience or coursework in biochemistry, molecular biology, protein bioengineering, and/or cell physiology
  • Excellent experimental design and analysis skills
  • Experience with Microsoft Office apps (Word, PowerPoint, Excel)
  • Experience with bioinformatics tools such as DNA and protein sequence analysis

Preferred Qualifications:

  • Experience with Geneious, VectorNTI, Ugene, or similar software
  • Laboratory experience with high-throughput vector assembly methodologies, DNA sequencing (Sanger and Next-gen), and plasmid purification
  • Laboratory experience with electrophoresis and chromatography methods
  • Laboratory experience with mammalian protein expression
  • Laboratory experience with protein library generation and screening
  • Experience programming and using liquid handling robots
  • Experience with data analysis, R, python and ELNs

About Just.Bio

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019. Just.Bio, an Evotec company, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

please send resume and cover letter

Associate Scientist, Process Development  | Just. – Seattle, WA

Just.Bio is seeking motivated and creative Associate Scientists, who desire a significant opportunity to improve worldwide access to biotherapeutics.  We arelooking for team members to join a fast-paced, collaborative, and multidisciplinary group to support process development for low-cost biotherapeutic manufacturing.  The successful candidates will have some experience in one or more of the following areas including chromatography, filtration, electrophoresis, analytical chemistry, cell culture and/or bioreactor operations. Experience with high throughput, robotic techniques for analytical testing, chromatography, and/or protein expression, as well as statistical design of experiments and/or process modeling, is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams. This position may include the opportunity to rotate through different functional areas to gain experience in different techniques and disciplines.

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Examples of Potential Responsibilities:

  • Work with team members to develop cell lines for biotherapeutics manufacturing
  • Work with team members to develop upstream/downstream processes for biotherapeutics manufacturing
  • Transfer manufacturing processes to clinical and commercial manufacturing facilities
  • Work with team members to support process development with high-throughput analytical procedures
  • Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results
  • Work with team members across functions on technology development to reduce the cost and improve the efficiency, speed, and capacity of process development and manufacturing

Requirements:

  • BS in Chemistry, Biochemistry, Molecular and Cellular Biology, Chemical Engineering, Bioengineering or related field and 0-3 years experience
  • Experience or coursework in chromatography, filtration, analytical chemistry, biochemistry, molecular biology and/or cell physiology
  • Excellent experimental design and analysis skills
  • Experience with Microsoft Office apps (Word, PowerPoint, Excel)

Preferred Qualifications:

  • Experience with chromatography systems such as HPLC/UPLC, FPLC or Akta
  • Experience with analytical instrumentation data systems
  • Cell culture or bioreactor experience
  • Experience with troubleshooting complex instrumentation
  • Experience with design of experiments (DOE), statistical analysis, and/or process modeling
  • Strength in data science and informatics

About Just.Bio

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just.Bio, an Evotec company, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

please send resume and cover letter

Automation Engineer, MES – Technical Operations  | Just. – Redmond, WA

Just.Bio is seeking a motivated and creative Automation Engineer, MES that desires a significant opportunity to improve worldwide access to biotherapeutics.  The Automation Engineer, MES will be part of the Manufacturing Automation team in the Technical Operations organization to support the design, implementation, and commissioning of MES systems and functionalities to clinical and commercial manufacturing at Just Biotherapeutics.  The engineer will also support manufacturing process automation systems (PAS) using DeltaV.  The successful candidate will have demonstrated proficiency in MES deployment and system administration, integration of MES with related business and automation systems, and an understanding of DeltaV automation used for bioprocessing controls systems (SCADA and DCS).  Experience working in a GMP environment, change control, and software validation in accordance to GAMP5 guidelines is highly preferred.

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Responsibilities (including but are not limited to):

  • Collaborate with key stakeholders and provide significant input and guidance in identifying and implementing MES domain and functional domain solutions for clinical and commercial manufacturing
  • Apply risk-based approach to develop design requirements, functional specifications, and support computer system validation strategy
  • Translate process requirements and MES system best practices into practical, usable electronic batch records
  • Participate in the development of global standards for batch record design, integration with process/test equipment and other electronic business and automation systems
  • Develop business processes, guidelines, SOPs, and training for the MES system
  • Participate in the development of MES system life cycle strategy and business/technical processes for change management
  • Provide system administration and ownership support for DeltaV PAS. Support includes maintaining and managing the following:
    • Infrastructure and networking architecture
    • Migration planning and execution
    • Patching, Security and Compliance
    • Backup/Restore and Disaster Recovery
    • Overall system and hardware reliability

Position Requirements:

  • S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
  • 7+ years of MES experience in Pharmaceutical, Biotech, or Life Sciences industries with 5+ years of experience with current Good Manufacturing Practice (cGMP) Regulations
  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
  • Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards
  • Leverage experience of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation
  • Knowledge and application of IT infrastructure and applications (server virtualization, security, wireless communication protocols, firewalls, etc.)

Additional Preferred Qualifications:

  • Previous experience in computer software validation
  • Leverage expertise using GAMP5 guidelines for risk-based approach to computer system validation
  • Applies knowledge and expertise to solve complex technical problems
  • Authority inspection or audit support involvement
  • Experience with single-use technologies and systems
  • Experience with DeltaV PAS

About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio

.

Automation Engineer, MES – Technical Operations

please send resume and cover letter

Director – Manufacturing Operations | Just. – Redmond, WA 

Just is seeking a highly motivated Director, Manufacturing Operations, that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to lead a group of manufacturing staff in the execution of late-stage clinical and commercial biologics manufacturing operations, including cell culture, purification, and media/solutions preparation. This position requires significant on-the-floor presence and leadership, focused specifically on day-to-day operations using disposable-based manufacturing technologies and ensuring cGMP compliance. Additional job responsibilities may include troubleshooting and/or providing technical expertise, finite scheduling, ensuring staff training compliance, executing against approved written procedures, participating in commissioning and validation activities, maintaining required cGMP compliant systems, and providing support for regulatory and site inspections.

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Educational Requirements:

  • Bachelor’s degree in biological or engineering science with 15+ years relevant experience

Qualification Requirements:

  • Technical mastery of cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies
  • Proven knowledge of cGMP requirements to ensure compliance
  • Previous experience managing the activities of both individuals and large groups of staff
  • In-depth knowledge of equipment, operations, and engineering principles
  • Candidate must possess strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • Strong understanding of process automation (e.g. DeltaV) and BAS systems
  • Commissioning and validation experience, including risk assessments, user requirement specifications, execution of DQ, IQ, OQ, and PQ activities, and validation summary reports
  • Applies knowledge and expertise to solve complex technical problems
  • Significant contributor to multi-disciplinary teams at the functional level
  • Mentors and provides technical advice to individuals within the team
  • Thorough working knowledge of US FDA CFRs and European EMA, including ICH regulations

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.

Director – Manufacturing Operations

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Manager, Manufacturing – J.POD Cell Culture | Just. – Redmond, WA 

Just is seeking a highly motivated cell culture manufacturing manager that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful execution of upstream clinical and commercial manufacturing operations while ensuring cGMP compliance. This position will responsible for supervising and overseeing multiple shifts to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in cell culture operations.  Additional job responsibilities will include generation and maintenance of cGMP manufacturing and technical documentation, troubleshooting and/or providing technical expertise to perform troubleshooting efforts or lead investigations, ensuring staff training and compliance, execution of plant start-up commissioning and validation activities, and implement and maintain required cGMP compliant systems.  The manager may also participate in finite scheduling, aspects of technology and/or process transfer, identify process gaps and technology issues, determine solutions and remediation plans, provide support for regulatory and site inspections, and provide input to department capital and expense budgets.

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Educational Requirements:

  • Bachelor’s degree in biological or engineering science with 8+ years relevant experience

Qualification Requirements:

  • Proven knowledge of cGMP requirements to ensure compliance
  • Significant experience in cell culture operations required for the manufacture of biotherapeutics
  • Proven record of accomplishment managing, supervising and developing staff
  • Candidate must possess strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills
  • Capacity to develop solutions to technical issues of moderate scope
  • Ability to organize, analyze/interpret, and effectively communicate data and results
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • In-depth knowledge of cell culture equipment, operations, and engineering principles
  • Recognized technical mastery of disposable manufacturing technologies at commercial scale
  • Participation in client and regulatory agency audits
  • Experience with finite scheduling tools and allocation of resources and equipment
  • Change control, NC/CAPA, and deviations
  • Fundamental understanding and basic operation of process automation (DeltaV)
  • Experienced in technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
  • Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
  • Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team
  • Active participation/lead technical projects with collaborators and vendors

About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

Manager, Manufacturing – J.POD Cell Culture

please send resume and cover letter

Manager, Manufacturing – J.POD Purification | Just. – Redmond, WA 

Just is seeking a highly motivated purification manufacturing manager that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to guide the successful execution of downstream clinical and commercial manufacturing operations while ensuring cGMP compliance. This position will responsible for supervising and overseeing multiple shifts to cover 24/7 operation and requires significant on-the-floor presence, as well as technical subject matter expertise in purification operations.  Additional job responsibilities will include generation and maintenance of cGMP manufacturing and technical documentation, troubleshooting and/or providing technical expertise to perform troubleshooting efforts or lead investigations, ensuring staff training and compliance, execution of plant start-up commissioning and validation activities, and implement and maintain required cGMP compliant systems.  The manager may also participate in finite scheduling, aspects of technology and/or process transfer, identify process gaps and technology issues, determine solutions and remediation plans, provide support for regulatory and site inspections, and provide input to department capital and expense budgets.

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Educational Requirements:

  • Bachelor’s degree in biological or engineering science with 8+ years relevant experience

Qualification Requirements:

  • Proven knowledge of cGMP requirements to ensure compliance
  • Significant experience in the purificaiton operations required for the manufacture of biotherapeutics
  • Proven record of accomplishment managing, supervising and developing staff
  • Candidate must possess strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills
  • Capacity to develop solutions to technical issues of moderate scope
  • Ability to organize, analyze/interpret, and effectively communicate data and results
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • In-depth knowledge of purification equipment, operations, and engineering principles
  • Recognized technical mastery of disposable manufacturing technologies at commercial scale
  • Participation in client and regulatory agency audits
  • Experience with finite scheduling tools and allocation of resources and equipment
  • Change control, NC/CAPA, and deviations
  • Fundamental understanding and basic operation of process automation (DeltaV)
  • Experienced in technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
  • Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
  • Significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team
  • Active participation/lead technical projects with collaborators and vendors

 About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio

.

Manager, Manufacturing – J.POD Purification

please send resume and cover letter

Process Engineer, Upstream – Manufacturing Technical Operations | Just. – Redmond, WA 

Just is seeking a highly motivated Process Engineer in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics.  The primary focus of this job is to provide project leadership for process transfer / tech transfer for clinical and commercial biologics manufacturing, including the development and maintenance of technical documentation within cGMP compliant systems.  The selected candidate will also be responsible for troubleshooting and/or providing technical expertise to perform or lead investigations.  In addition, this team member will also evaluate, develop, and implement new manufacturing technologies and equipment, including disposable-based systems and continuous processing technologies for a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility.  The staff member may also provide person-in-plant support to partners, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections, and provide input to department capital and expense budgets.  This position may work independently or supervise others.

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Position Requirements:

  • Bachelor’s degree in engineering science or related program with 10+ years relevant experience
  • Extensive knowledge and hands on experience with biologics drug substance manufacturing processes
  • Considered a subject matter expert in the area of upstream processing, including single-use bioreactors and perfusion technology, but also knowledgeable in downstream process chromatography and filtration.
  • Experienced in leading technology and/or process transfer teams for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
  • Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
  • Working knowledge of manufacturing process equipment and automation systems
  • Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
  • Ability to organize, analyze/interpret, and effectively communicate individual results
  • Good interpersonal, team, and collaborative skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • Recognized technical mastery of disposable manufacturing technologies from bench-scale through commercial scale
  • Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
  • Can work independently and/or manage the activities of individuals, work group, or project teams; significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team
  • Active participation/lead technical projects with collaborators and vendors
  • Ability to navigate global regulatory CMC documents

About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio

.

 

Process Engineer, Upstream – Manufacturing Technical Operations

please send resume and cover letter

Process Engineer, Downstream – Manufacturing Technical Operations | Just. – Redmond, WA 

Just is seeking a highly motivated Process Engineer in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics.  The primary focus of this job is to provide project leadership for process transfer / tech transfer for clinical and commercial biologics manufacturing, including the development and maintenance of technical documentation within cGMP compliant systems.  The selected candidate will also be responsible for troubleshooting and/or providing technical expertise to perform or lead investigations.  In addition, this team member will also evaluate, develop, and implement new manufacturing technologies and equipment, including disposable-based systems and continuous processing technologies for a first-of-its-kind flexible and reconfigurable cGMP manufacturing facility.  The staff member may also provide person-in-plant support to partners, assist in generation of relevant regulatory submissions, provide support for regulatory and site inspections, and provide input to department capital and expense budgets. This position may work independently or supervise others.

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Position Requirements:

  • Bachelor’s degree in engineering science or related program with 10+ years relevant experience
  • Extensive knowledge and hands on experience with biologics drug substance manufacturing processes
  • Considered a subject matter expert in the area of downstream processing, including downstream process chromatography and specifically continuous chromatography, large scale column packing, viral filtration, and tangential flow filtration, but also knowledgeable in single-use bioreactors and perfusion technology.
  • Experienced in leading technology and/or process transfer teams for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
  • Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
  • Working knowledge of manufacturing process equipment and automation systems
  • Candidate must possess strong focus on quality and attention to detail as well as effective task/ time management organizational skills
  • Ability to organize, analyze/interpret, and effectively communicate individual results
  • Good interpersonal, team, and collaborative skills are a must
  • Excellent oral and written communication skills

 Additional Preferred Qualifications:

  • Recognized technical mastery of disposable manufacturing technologies from bench-scale through commercial scale
  • Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
  • Can work independently and/or manage the activities of individuals, work group, or project teams; significant contributor to multi-disciplinary teams at the functional level; mentors and provides technical advice to individuals within the team
  • Active participation/lead technical projects with collaborators and vendors
  • Ability to navigate global regulatory CMC documents

About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

 

 

Process Engineer, Downstream – Manufacturing Technical Operations

please send resume and cover letter

Project Manager | Just. – Seattle, WA 

Just is seeking a highly motivated, creative, and driven project manager that desires a significant opportunity to improve worldwide access to biotherapeutics.  Reporting to the VP Program and Alliance Management, the project manager drives the development and execution of high quality, global, integrated cross-functional project plans for one or more products in support of the overall program strategy.The project manager will be responsible for providing project management support to molecule design, process and product CMC development teams and for driving decision making. The project manager is expected to be a technical and business expert in biotechnology CMC operations, including some broad knowledge of manufacturing, quality and regulatory requirements.

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Responsibilities:

  • In partnership with scientific and technical leaders and as part of the technical team provide project planning, execution, monitoring and reporting support
  • Assist in the management of external consultants – Support projects that utilize external consultants and partners
  • Enable and support information and data exchange between Just and its partners and clients.
  • Manage and prioritize support of multiple project teams at one time.
  • Enable cross company planning with other Evotec business and technical areas
  • Coordinate the assembly of regulatory filings
  • Provide meeting management support including meeting planning, scheduling, facilitation, documentation and outcomes communicated (i.e. Gantt charting, agendas, minutes, communication, and document management)
  • Provide project reporting: Critical path analysis, action item and task management and follow up, identifying and clarifying task dependencies
  • Provide project Management: Team facilitation, problem solving mediation, critical path and parameter analysis – Facilitate and incorporate lessons learned, best practices, etc.
  • Monitor team dynamics and support decision making
  • Identify project issues and facilitate resolution, conduct risk management and contingency planning
  • Ensure communication flow between groups, assist with issue resolution and ensure information transfer between functional areas. Collaborate and build constructive relationships throughout Just.

Qualifications and Education Requirements:

  • Bachelor’s degree in biological sciences, biochemistry, chemical engineering, or related field
  • Minimum 4 years of experience in a CMC drug development project management role
  • Demonstrated experience in a drug development project management role

Preferred Qualifications:

  • 8+ years of experience in a CMC drug development project management role
  • Drug development knowledge with strong understanding of research, preclinical, clinical, manufacturing, commercial and regulatory areas
  • Proven record of implementing biopharmaceutical project management tools, methodologies, practices, and infrastructure
  • Informed of current biopharmaceutical industry knowledge, news and trends
  • Pro-active, team player with strong sense of urgency
  • Independent, motivated, team member with experience in a matrix environment.
  • Ability to facilitate collaboration, effectively work on cross-functional teams, possess strong interpersonal skills and be capable of interface with the entire organization.
  • Excellent presentation, problem solving, risk analysis and critical thinking skills.
  • Experience with MS Project, Excel, PowerPoint, Word, OnePager

About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

Project Manager

please send resume and cover letter

Sr. Automation/Process Controls Engineer | Just. – Redmond, WA 

Just.Bio is seeking a motivated Sr. Automation/Process Controls Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics.  Process automation is a cornerstone of Just’s manufacturing technology.  The focus of this job is to support process automation systems (PAS) for both clinical and commercial manufacturing.  This includes designing and implementing creative solutions to complex technical challenges in helping Just achieve a novel flexible and reconfigurable cGMP manufacturing facility focused on continuous processing. The successful candidate will have an advanced understanding of DeltaV automation used for bioprocessing controls systems (SCADA and DCS) as well as at least some experience in other automation platforms (ie, Siemens, Allen-Bradley, Wonderware, etc.).  Experience working in a GMP environment, change control, and automation validation in accordance to GAMP5 guidelines is highly preferred.

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Responsibilities:

  • Provide system administration and ownership support for DeltaV PAS. Support includes maintaining and managing the following:
    • Infrastructure and networking architecture
    • Migration planning and execution
    • Patching, Security and Compliance
    • Backup/Restore and Disaster Recovery
    • Overall system and hardware reliability
  • Design and implement new automation and process control schemes to advance the state of continuous manufacturing including, but not limited to batch tracking, establishing process control limits, and applying predictive control algorithms.
  • Develop detailed specification, qualification (IQ/OQ/PQ), engineering, SOP, and training documents.
  • Work closely with multiple disciplines, including manufacturing, process engineering, process development, data scientists, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
  • Lead technical root cause analysis, incident investigations, and troubleshooting of process control issues
  • Provide technical support to commercial and clinical manufacturing as needed, specific to process control and automation infrastructure.
  • Provide project oversight on PAS implementation projects contracted to 3rd party suppliers/integrators

Position Requirements:

  • S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
  • 8+ years relevant experience in pharmaceutical, biotech, or life sciences
  • Strong control system automation background. Design, installation, programming and validation of automated processes is essential.
  • Thorough understanding of FDA CFR 21 Part 11 compliance
  • Established record of successful project completions employing proven engineering and project management skills
  • Candidate must possess strong focus on quality and attention to detail
  • Motivated, self-starter with strong organizational skills
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • Previous experience in computer software validation
  • Leverage expertise using GAMP5 risk-based approach when implementing changes to the validated PAS
  • Authority inspection or audit support involvement
  • Experience with single-use technologies and systems
  • Experience with Wonderware, Allen Bradley, Wonderware automation platforms

About Just – Evotec Biologics

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just – Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio

.

Sr. Automation/Process Controls Engineer

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Sr Automation Engineer, Process Design  | Just. – Seattle, WA

Just.Bio is seeking a motivated and creative Sr Automation Engineer, Process Design who desires a significant opportunity to improve worldwide access to biotherapeutics. This position will join a collaborative and multidisciplinary scientific team within the Process Design group to develop, deploy, and support automation solutions to speed process development activities for low-cost biotherapeutics manufacturing.  The ideal candidate is driven to create innovative strategies to improve processes and technology. The ability to work both independently and collaboratively in a fast-paced and dynamic environment is necessary for success in this position. Experience with multiple robotic liquid handling platforms and integrating automation solutions into existing workflows is a plus.

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Responsibilities:

  • Utilize multiple robotic platforms (particularly, Tecan, Hamilton, ambr) and optimize experiments in conjunction with process design scientists
  • Work with scientists to identify and solve bottlenecks and increase efficiency via automation
  • Develop and implement new automation strategies and build out new automation laboratories
  • Maintain robotic liquid handing systems and train new users
  • Troubleshoot time sensitive automation issues and optimize existing scripts and programming

Qualifications and Education Requirements:

  • BS in Engineering, Biology, Molecular Biology, Biochemistry or related field and minimum 8+ years of relevant experience
  • Extensive knowledge of automation and liquid handling robots, with strong troubleshooting skills
  • Experience scripting with Tecan Freedom EVOware™ and/or Hamilton STAR
  • Ability to interpret experimental needs and translate into automation scripts
  • Familiarity with a wide variety of automation hardware and ability to identify new applications to automate bench-scale workflows
  • Strong written and verbal communication skills and works well independently and in teams
  • Experience with Microsoft Office apps (Word, PowerPoint, Excel)

Preferred Qualifications:

  • Experience with biotechnology process development activities in analytical, upstream, downstream and/or formulation development
  • Experience with design of experiments (DOE) and statistical analysis
  • Experience with high throughput cell culture (e.g. deep-well plate assays or robotics)
  • Experience with implementing supervisory software
  • Experience implementing and validating automation in QC environment

About Just.Bio

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019.  Just.Bio, an Evotec company, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

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Senior Director, Manufacturing Technical Operations  | Just. – Redmond, WA

Just Bio is seeking a highly motivated Senior Director, Manufacturing Technical Operations, that desires a significant opportunity to improve worldwide access to biotherapeutics. The focus of this job is to lead and guide a group of process, automation, and validation engineers in the execution and support of late stage clinical and commercial biologics manufacturing operations. The primary job responsibilities will include process and technology transfer; GMP manufacturing and technical documentation generation and maintenance (e.g., manufacturing and operating procedures); equipment and utilities commissioning and validation; process validation; process automation implementation and validation; and advanced biologics manufacturing technology implementation. Additional job responsibilities will include troubleshooting and/or providing technical expertise to perform or lead investigations, assist in the generation of relevant regulatory submissions, implementation/maintenance of cGMP compliant systems, and provide support for regulatory and site inspections.

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Educational Requirements:

  • PhD or Master’s degree in biological or engineering science with 15+ years relevant experience or
  • Bachelor’s degree in biological or engineering science with 20+ years relevant experience

Qualification Requirements:

  • Previous experience in late-stage/commercial biologics manufacturing
  • Technical mastery of cell culture and purification operations at commercial scale
  • Proven knowledge of cGMP requirements to ensure compliance
  • Validation experience, including risk assessments, user requirements, design qualification, installation qualification, operational qualification, performance qualification, and validation summary reports
  • Strong understanding of process automation (e.g. DeltaV) and BAS systems
  • Previous experience managing the activities of individuals, work groups, and project teams.
  • Candidate must possess strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • Thorough working knowledge of US FDA CFRs and European EMA, including ICH regulations
  • In-depth knowledge of equipment, operations, and engineering principles
  • Experienced in technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns; commercial campaign support is a plus
  • Applies knowledge and expertise to solve complex technical problems; may apply novel approach that provides significant technology advancement
  • Active participation/lead technical projects with collaborators and vendors

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.

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Senior Scientist, Computational Structural Biologist | Just. – Seattle, WA

Just is seeking a highly motivated and creative computational structural biologist to help invent and apply antibody and protein therapeutic design technologies for application in the areas of antibody humanization, therapeutic modality design, antibody developability optimization, antibody discovery library designs, and therapeutic discovery analyses. The successful candidate will interface with expertise across therapeutic development including discovery, characterization, process development, and manufacturing. The candidate will also have the ability to actively implement designs on the bench, including designed variants and display libraries.

The successful candidate must also possess strong communication and collaboration skills, a desire to learn new scientific concepts and domains, and an ability to work directly with scientific staff across multiple disciplines.

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Examples of Potential Responsibilities:

  • Work independently and in teams to develop, implement, and utilize biologics therapeutic design methods
  • Work with external and internal clients on antibody therapeutic design and optimization projects
  • Collaborate with and provide computational structural biology support for the Data Science team
  • Aid in the design of antibody display libraries for discovery efforts
  • Provide structural and bioinformatic support for discovery screen results
  • Collaborate with scientific staff across multiple disciplines to accomplish goals

Requirements:

  • Ph.D. with 2-5 years experience with strong experience in computational structural biology
  • Strong experience in therapeutic antibody and immunogen designs
  • Strong experience with computational structural biology platforms
  • Strong drive toward innovation
  • Excellent verbal and written communication skills
  • Strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills

Preferred Qualifications:

  • Experience in a commercial biotherapeutic development environment
  • Experience with the Molecular Operating Environment
  • Laboratory experience in molecular biology and antibody expression
  • Laboratory experience with epitope binning and mapping methods
  • Laboratory experience in elucidating protein-protein interactions
  • Laboratory experience with high-throughput screening and protein biochemistry methods 
  • Familiarity with Next Generation Sequencing technologies
  • Familiarity with yeast display technologies
  • Ability to work in small groups as well as independently
  • Ability to organize, analyze/interpret, and effectively communicate results

About Just.Bio

Established in 2014, Just Biotherapeutics, Inc. was acquired by Evotec SE in 2019. Just.Bio, an Evotec company, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

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Senior/Principal Scientist, Cell Physiology/Media Development | Just. – Seattle, WA

Just is looking for a Senior/Principal scientist to join a fast-paced, collaborative, and multidisciplinary team to develop cell culture media for the advancement of low-cost biotherapeutics manufacturing.  The position requires a deep understanding of cell physiology, biochemistry, metabolism, experimental design and statistical analysis.  Experience with high throughput mammalian cell culture and assay development is highly desirable.  Strong written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings are necessary.  The ideal candidate is curious, creative, works independently and in teams, and looks for ways to improve processes and technology.

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Responsibilities:

• Utilize understanding of cell physiology and metabolism to develop cell based models of high density perfusion processes

• Develop cell culture media formulations through analytical and cell culture-based experiments

• Develop and apply new methods to advance cell culture media technology

• Collaborate across the organization, with clients, and manufacturing groups

Requirements:

• BS in Engineering, Cell Biology, Molecular Biology, or related field with 10+ years of experience or Ph.D. with 2+years of experience

• Experience developing media for mammalian cell lines

• Experience with design of experiments (DOE) and statistical analysis

• Stay abreast of current literature as it relates to media development for recombinant protein expression

• Publish and present research

• Act as an internal technical resource

Pluses:

• Experience with high throughput cell culture (e.g. deep-well plate assays or robotics)

• Experience with bioreactor cell culture and perfusion technology

• Experience with JMP, R, Python

About JustJust is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. Just is developing a portfolio of molecules that best leverages our technological strengths. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.

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Senior Manager/Director, Quality Assurance | Just. – Seattle, WA

Just is seeking a highly motivated and self-directed Quality professional who desires a significant opportunity to improve worldwide access to biotherapeutics. In this position, you will work as a member of a small but highly experienced and innovative team to ensure high quality standards for the safe and reliable production of biological products. The ideal candidate will have significant experience in leading all Quality Assurance and batch disposition activities related to the manufacturing of biological products from Phase 1 through Commercial stages. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.

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Responsibilities:

  • Lead and direct all aspects of the Quality Assurance function to assure compliance with quality and industry regulatory requirements
  • Direct and manage the QA review and approval of Master Batch Records, Executed Batch Records, and analytical testing.
  • Direct and manage the QA assessment and review, including investigations and approval of NC/CAPA documentation.
  • Execute product disposition and release
  • Manage the QA communication and lot disposition process with CDMO client base.
  • Organize and conduct internal and external audits of the quality assurance management system
  • Assist in and monitor Change Control, Validation, and Risk Management activities
  • Implement process performance and product quality monitoring programs
  • Assist in IND and BLA regulatory submissions
  • Host and interact with regulatory agency representatives
  • Investigate complaints and adverse events
  • Collect and compile statistical quality data
  • Alert senior management of significant quality, compliance, supply and safety risks

Educational Requirements:

  • Bachelors degree in biological or engineering science with 10+ years relevant experience

Preferred Qualifications:

  • Certifications, including Quality Auditor, Quality Engineer, Six Sigma
  • Experience in helping to build and maintain a Quality infrastructure in a fast-paced growing company
  • Comprehensive understanding of relevant regulatory requirements
  • Expertise in tools, concepts, and methodologies of QA
  • Strong computer skills including Microsoft Office and databases
  • Key competencies in verbal and written communication; attention to detail; data collection, management, and analysis; judgement and decision making; and teamwork

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.

please send resume and cover letter

Senior Validation Engineer – Manufacturing Technical Operations | Just. – Redmond, WA

Just is seeking a highly motivated Senior Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to lead the equipment and utilities validation activities required for late-stage clinical and commercial biologics manufacturing. This comprises all phases of implementation, including ownership of key deliverables such as risk assessments, user requirements specifications, functional specifications, and design specifications. The selected candidate will also be responsible for protocol generation (IQ/OQ/PQ), as well as validation summary reports. Additional job responsibilities will include periodic review and requalification of validated equipment and systems to verify compliance with appropriate regulations and maintaining required change control procedures and impact assessments. This position may/will also oversee protocol execution through in-house staff and/or contractors, as well as participate and defend Just’s Validation Program during regulatory and site inspections.

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Educational Requirements:

  • Bachelor’s degree in engineering science or related program with 10+ years relevant experience

Qualification Requirements:

  • Comprehensive understanding of industry standards and best practices for equipment and utilities validation
  • Thorough working knowledge of US FDA CFRs and European EMA, including ICH regulations
  • Practical experience with quality risk management and risk-based validation approaches
  • Established record of successful project completions employing proven engineering and project management skills
  • In-depth knowledge of equipment, operations, and engineering principles
  • Candidate must possess strong focus on quality and attention to detail
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • Previous work experience with Distributed Control System (DCS), Building Automation Systems (BAS), PLC, SCADA, PI, and MES will be a plus
  • Strong understanding of process automation (e.g. DeltaV)
  • Applies knowledge and expertise to solve complex technical problems
  • Significant contributor to multi-disciplinary teams at the functional level
  • Mentors and provides technical advice to individuals within the team

About Just

Just is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.

please send resume and cover letter

Just is proud to be an equal opportunity employer and values diversity at our company.
We are committed to equal employment opportunity regardless of race, color, ancestry,
religion, sex, national origin, sexual orientation, age, citizenship, marital status,
disability, gender identity or veteran status.