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

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

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

please send resume and cover letter

Director, Regulatory CMC | Just. – Seattle, WA 

Just.Bio is seeking a Director of Regulatory CMC to join a fast-paced, collaborative and multi-disciplinary team to lead all aspects of regulatory affairs for the advancement of low-cost biotherapeutics manufacturing. You will be joining at an exciting time when Just.Bio is making game changing advances in biologics discovery, development and manufacturing. The primary responsibilities are to develop and execute global CMC regulatory strategies towards regulatory adoption of innovative approaches to biologics product and process design, and manufacturing; to lead and manage CMC matters for internal and external products and programs.   The Director of Regulatory CMC will have oversight for planning, preparation, and execution of CMC-related communication and documentations for engagement with regulatory authorities. The role includes serving as a Regulatory CMC resource for biologics for Evotec. The successful candidate will possess strong interpersonal and team skills to advise and persuade internal and external stakeholders.

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Responsibilities:

  • Interpret global CMC regulations and provide strategic direction and regulatory guidance that are relevant to technologies, products and systems being developed by Discovery, Process Development, Quality and Manufacturing
  • Regulatory input on the design of the J.POD commercial multi-product and multi-modality manufacturing facility
  • Coordinate appropriate meetings such as with the FDA Emerging Technology Team to discuss, identify and resolve potential regulatory issues regarding the design and operations of J.POD manufacturing
  • Lead and manage of Chemistry, Manufacturing & Controls (CMC) components for products in early-to-late stage development
  • Lead and coordinate interactions with global regulatory authorities to ensure acceptance, rapid review and approval of applications, supplements/variations and submissions which present CMC information
  • Develop innovative strategies and provide Regulatory Affairs input for clients and business partners on all CMC related matters
  • Assure Type V Master File, Letters of Authorizations, and Annual Reporting filings are maintained in accordance with regulatory requirements.

Qualification and Education Requirements:

  • BA/BS degree in molecular biology, cell biology, biochemistry, protein chemistry or similar.
  • Minimum of 10 years of experience in Regulatory Affairs CMC
  • Minimum of 12 years in related disciplines in the pharmaceutical or biotechnology industry in development, quality and cGMP manufacturing

Preferred Qualifications:

  • 15+ years related experience with an advanced degree in related discipline
  • Outstanding interpersonal and communication skills with demonstrated ability to work with cross functional teams comprised of discovery, process development, quality and manufacturing.

Experience collaborating with CDMOs, contractors and partners is a plus

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.

Director, Regulatory CMC

please send resume and cover letter

Senior Technical Manager, Quality Assurance | Just. – Seattle, WA

Just is seeking a highly-motivated Technical Manager within the Quality group that desires to be part of a team focused on improving worldwide access to Biotherapeutics by supporting GMP plant operations.  This individual will join the Quality team at Just with their primary responsibility being the building and enhancing the quality assurance systems along with supporting day-to-day QA responsibilities for GMP manufacturing.  The ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment are essential to be successful in this position.

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Responsibilities

  • Oversee and develop the Change Control, Equipment commissioning and qualification, and document management quality programs.
  • Develop and improve the Quality Risk Management program, including facilitating data-driven risk assessments and risk reviews, by combining technical and compliance-based rationale to drive procedures.
  • Support the GMP training program to ensure compliance with early clinical GMP manufacturing.
  • Drive the maturation of the NC/CAPA program and collaborate with manufacturing to determine cause, corrective action, and impact for deviations.
  • Oversee Just’s equipment management program to ensure manufacturing equipment is in a state of control, including reviewing and approving equipment calibration and preventative maintenance documents.
  • Provide Quality oversight to quality risk management documentation and equipment facilities utilities qualification for a process transfer from development to Phase I/II clinical drug substance manufacturing.
  • Mentor manufacturing and development groups in qualification/validation technical aspects, and compliance requirements.
  • Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
  • Works collaboratively with both internal/external collaborators, vendors, and regulatory agencies to anticipate and resolve quality issues as well as maintain GMP compliance.

Qualifications and Educational Requirements

  • Bachelor’s degree in biological sciences, chemistry, biochemistry, engineering or related life science field.
  • 8 – 10+ years relevant experience in a biopharmaceutical cGMP manufacturing or similar environment.

Preferred Qualifications

  • Requires thorough knowledge of cGMPs and regulations applicable to the FDA and comparable international regulatory agencies to ensure compliance.
  • Experience in technology and/or process transfer for late state clinical manufacturing or commercial qualification drug substance campaigns; commercial campaign support is a plus.
  • Involvement with both technical and quality aspects of biologics manufacturing.
  • Knowledge and expertise to solve complex technical problems.
  • Significant experience navigating and managing various modules in a Quality Management System software suite.
  • Excellent verbal and written communication skills.
  • Strong focus on quality and attention to detail.
  • Possess effective task/time management organization skills
  • Capacity to develop solutions to technical issues of moderate to complex scope.
  • GMP and compliance knowledge and experience with equipment qualification and validation in a cGMP manufacturing setting
  • Previous experience working in upstream and/or downstream drug substance manufacturing

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

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.

please send resume and cover letter

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.

please send resume and cover letter

Scientist / Senior Scientist, Analytical | Just. – Seattle, WA

Just is seeking a motivated and creative Scientist / Senior Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics.  We arelooking for a motivated scientist to join a fast-paced, collaborative, and multidisciplinary team.  As a key member of the Analytical group, you will possess strong skills in large molecule characterization, method development and qualification, and authoring regulatory authority correspondence and interaction. The successful candidate will possess strong leadership and management skills and a strong drive for laboratory work. Experience with biosimilar development as well as functional biocharacterization is a plus. The ideal candidate has strong written and verbal communications skills and works well independently and in teams.

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Responsibilities:

• Develop, qualify, and document analytical methods

• Work with team members to support process development teams with high-throughput analytical procedures

• Develop and implement molecule characterization strategies

• Utilize chromatography data systems and informatics platforms to analyze and distribute analytical results

• Work with team members on technology development to reduce the cost and improve the efficiency, speed, and capacity of analytical testing and analytical methods

Requirements:

• BS + 10 years experience or MS + 5-7 years experience in Chemistry, Biochemistry or related field

• Large molecule and protein characterization experience

• Strong assay development and qualification skills

• Proven record with authoring regulatory documents (eg IND/BLA)

• Desire to work in a fast, collaborative, team-oriented environment

Preferred qualifications:

• Strong background in HPLC (SEC, RP, HILIC), CE (CESDS, CZE), and ELISA

• Experience with Biosimilar characterization and comparability

• Experience with troubleshooting complex instrumentation

• Direct interactions with FDA and other regulatory agencies a plus

• Strong skills in Mass Spectroscopy

• Characterization of complex Glycoproteins

• Experience with compendial assays (USP, EP, JP)

• Strength in data science and informatics

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.

please send resume and cover letter

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.

please send resume and cover letter

Sr Scientist, Mass Spectrometry | Just. – Seattle, WA

Just is seeking a motivated and creative Scientist, who desires a significant opportunity to improve worldwide access to biotherapeutics.  We arelooking for a driven scientist to join a fast-paced, collaborative, and multidisciplinary team.  As a key member of the Mass Spectrometry group, you will possess strong skills in large molecule characterization, method development and qualification.  Strong organizational skills, a familiarity with scientific software such as Sequest, Comet, BioPharma Finder, Protein Metrics, Chromeleon, and Genedata Expressionist are also desirable for this position.The ideal candidate has strong written and verbal communications skills and works well independently and in teams.

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Responsibilities:

• Method development for mass spectrometry-based experiments

• Characterization of biotherapeutics using mass spectrometry (intact mass and multi-attribute method (MAM))

• Work with team members on technology development to reduce the cost and improve the efficiency, speed, and capacity of analytical testing and analytical methods

Requirements:

• Ph.D. in Chemistry, Biochemistry or related field and 3-5+ years industry experience

• Hands-on experience with TOF and Orbitrap technology

• Large molecule and protein characterization experience

• Strong assay development and qualification skills

• Desire to work in a fast, collaborative, team-oriented environment

Preferred qualifications:

• Experience with Biosimilar characterization and comparability

• Experience with troubleshooting complex instrumentation

• Strength in data science and informatics

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.

please send resume and cover letter

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.

please send resume and cover letter

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

Sr Scientist, Yeast Library | Just. – Seattle, WA

Just is seeking a highly motivated and creative yeast display library expert that desires a significant opportunity to help invent the technologies required to improve worldwide access to biotherapeutics. This position will be part of a cross-discipline team developing antibody libraries for discovery, therapeutic optimization, and high throughput characterization. The successful candidate will be part of a cross-discipline team which will invent, design, and implement yeast display library methods to drive biotherapeutic development, with strong experience with library design and implementation methods, library screening methods such as FACS, and antibody yeast expression. This position will work closely with bioassay, bioanalytical, and process development colleagues in an integrated and collaborative environment

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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Responsibilities:

• Work independently and in teams to develop, implement, and utilize antibody yeast libraries

• Design of expression vectors

• Perform high-throughput screening requiring some knowledge of laboratory robotics

• Collect, analyze, and act on NextGen Sequencing and FACS data

• Affinity characterize lead candidates

• Perform expressions and high throughput purifications of lead candidates

• Collaborate with scientific staff across multiple disciplines to accomplish goals

Qualifications and Education Requirements:

• Ph.D. or equivalent experience with strong experience in yeast display antibody library technologies

• Experience with affinity characterization

• 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 biotherapeutic development environment

• Experience with high throughput bioassays

• Experience with epitope binning and mapping methods

• Experience in vector design and utilizing high-throughput, cost-effective DNA synthesis technologies

• Experience with other display technologies, protein secretion, cellular trafficking, and cell-surface capture and release methods

• Experience with genome integration, editing, and manipulation methods

• Ability to work in small groups as well as independently

• Ability to organize, analyze/interpret, and effectively communicate results

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. 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.

please send resume and cover letter

Warehouse Associate | Just. – Seattle, WA

Just is seeking a highly motivated Warehouse Associate that desires a significant opportunity to improve worldwide access to biotherapeutics. This team member will be responsible for receiving, sampling, storing, issuing, and shipping materials in a GMP warehouse. This individual will work with Manufacturing, Quality, and Supply Chain Teams to ensure that inventory levels are accurate, materials are stored properly, and support all manufacturing activities at the site. The staff member is expected to comply and follow written procedures for safety requirements, cGMP Practices, Standard Operating Procedures, and manufacturing documentation.

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Job Responsibilities:

  • Receive, unpack, and log all materials coming into the facility
  • Inspects shipments for accuracy and completeness; resolves inconsistencies
  • Locate and store all inventoried items using inventory management system and physically locate them
  • Work with Quality and Manufacturing to kit all materials for GMP production use
  • Monitors and maintains current inventory levels
  • Performs physical cycle counts of inventory and reconciles stock to database reports
  • Prepare all shipments according to written and validated procedures
  • Organize and maintain the warehouse in safe and clean condition

Educational Requirements:

  • Bachelor’s degree in Supply Chain, Business, or Engineering

Qualification Requirements:

  • This is an entry level position, but 1+ years of pharmaceutical or GMP warehouse material handling experience is preferred.
  • Must be physically able to lift and move materials (up to 50 lbs.) safely
  • Candidate must possess strong focus on quality and attention to detail
  • Possess effective task/time management organizational skills
  • Ability to organize, analyze/interpret, and effectively communicate requirements and results
  • Good interpersonal, team, and communication skills are necessary
  • Excellent oral and written communication skills

Additional Preferred Qualifications:

  • Knowledge of cGMP requirements to ensure compliance
  • Proven record of success in a logistical support for Materials Management and Supply Chain Functions
  • Experience with inventory management software systems
  • Lean Six Sigma

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.