Director, Technology Transfer Manufacturing Technical Ops
Just is seeking a recognized technology transfer leader in the Manufacturing Technical Operations group that desires a significant opportunity to improve worldwide access to biotherapeutics. The Director of Technology Transfer role will be responsible for building a team of engineers and scientists to lead tech transfer projects for our Seattle and Redmond clinical and commercial manufacturing facilities. The selected candidate will establish and direct the execution, resources, business processes, and NPI (new product introduction) project oversight of our biologics drug substance processes. A key area of focus for the successful candidate will be building the product life cycle business process for our late-stage clinical and commercial programs, including defining the process validation strategy, and supporting regulatory filings and agency interactions. The candidate will also collaborate with Process Development, Manufacturing, Quality, Regulatory, and Supply Chain teams, as well as interact with clients to ensure process implementation success into our facilities.
- B.S. or higher degree in engineering science or related program with 15+ years relevant experience
- Extensive knowledge and experience with biologics drug substance manufacturing processes, with an emphasis on late-stage clinical and commercial programs
- Solid understanding of upstream and downstream processing technologies, continuous processing, and disposable manufacturing technologies from bench-scale through commercial-scale
- Demonstrated leadership capabilities to build and mentor high performing teams, drive change, and influence internal and external stakeholders
- Recognized expert in the field of manufacturing sciences, including technology transfer, scale-up, process risk assessments, process modeling, process monitoring, and process validation
- Significant experience with process risk assessment tools (e.g. FMEA), and facilitating risk assessments
- Proven knowledge of cGMP requirements and experience writing manufacturing technical documents
- Good interpersonal, team, and collaborative skills are required
- Excellent oral and written communication skills
Additional Preferred Qualifications:
- Working knowledge of manufacturing process equipment, DeltaV automation systems, and Manufacturing Execution Systems
- Experience authoring global regulatory CMC documents, especially BLA or MAA documents, and supporting regulatory agency interactions, including Type C meetings and PAIs.
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 200+ employees is expanding Just’s innovative platform and footprint – building our first North American J.POD® commercial manufacturing facility in the Seattle area.