Vice President, Manufacturing Operations | Redmond, WA |
Just-Evotec Biologics is seeking a highly motivated Vice President, Manufacturing Operations, that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to lead and guide the late stage clinical and commercial biologics manufacturing operations (Cell Culture, Purification, and Support Services) at Just-Evotec Biologics state of the art J.POD™ Facility located in Redmond WA. This highly qualified candidate will partner with Technical Operations, Quality Assurance, Facilities & Engineering, Materials Management, Supply Chain, and EH&S functions to ensure plant operational readiness and success. Dependent upon the candidates experience and qualifications, this position may also oversee the early clinical stage biologics manufacturing operations at the J.Plant Clinical Facility, located in Seattle WA.
The initial job duties will be to manage and act as a project leader of multiple cross-functional workstreams. The primary goal is to complete the design, build, and validation of the J.POD™ Facility and associated production/quality systems; ensuring that these are suitable for phase 3 manufacturing, pre-positioned to be commercially compliant, inspection ready, and licensable by US FDA and EMA health authorities.
Additional job responsibilities will include: manage site performance, ensuring operational excellence; review and approve GMP controlled documentation, ensuring that they meet technical and regulatory requirements; plant staff and equipment operations scheduling; successful execution of advanced biologics manufacturing technologies; troubleshooting and/or providing technical expertise to perform or lead investigations; assist in the generation of relevant regulatory submissions; implementation and/or maintenance of cGMP compliant systems; provide support for regulatory and site inspections, manage OPEX and CAPEX budgets; develop a culture of continuous improvement; incorporate and expand sustainability into manufacturing operations; build and develop staff for future roles and career progression; and ensure a culture of safety.
- 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
- Extensive experience in late-stage/commercial biologics drug substance manufacturing
- Technical mastery of cell culture and purification operations at commercial scale
- Proven knowledge of cGMP requirements to ensure compliance
- Advanced skills in the operation of single-use technologies, including cell culture, purification and drug substance filling operations
- Validation experience, including risk assessments (SIA and CIA), 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
- Experienced in the use of electronic systems such as QMS, MES/EBR, CMMS, and ERP 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
- Strong computer skills include Microsoft Office (Word, Excel, Power Point, and MS Project)
Additional Preferred Qualifications:
- Thorough working knowledge of US FDA CFRs and European EMA, including ICH guidelines
- 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
- Development, scale-up, and transfer of biologics production processes
- 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 – Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, 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. Just’s focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle’s South Lake Union neighborhood – the center of Seattle’s medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers
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