Senior Manager Bioreactor Process Design

Senior Manager Bioreactor Process Design

CDI/Permanent position

Just - Evotec Biologics is looking for a Manager of Bioreactor Process Design to join a fast-paced, collaborative, and multidisciplinary team to lead Upstream development projects. In this role, you will participate in further developing and refining Just’s next-generation continuous bioprocessing platform, which we are currently running in our Seattle and Redmond manufacturing facilities at the 500L and 1000 L scale. Just - Evotec employees are driven by our mission: to expand access to therapeutics by substantially driving down cost of goods through process technology development. This role is well-positioned to have a substantial impact on patients and the biotechnology industry.

This position will oversee upstream process development for early and late-stage processes and will include process development, optimization, characterization, and technology transfer for intensified, continuous processes. The position requires strong management and leadership skills as well as a deep understanding of bioreactor design, process optimization, scaleup and automation. A proven track record of technical skills in this area as well as experience in leading groups of scientists is required. Experience with ambr bioreactors, statistical tools, bioreactor automation, process modelling is a plus.
- Missions and responsibilities_:

- Become accountable for the global strategy of bioreactor process development for biosimilar entities from project initiation up to product commercialization based on the client's needs.
- Lead all aspects of upstream process development, scale down model qualification, process characterization and tech transfer to cGMP manufacturing.
- Drive technology development for process intensification and continuous manufacturing process to reduce manufacturing costs and footprint through improvements in process yield and efficiency, control of product quality, and data management.
- Build and maintain scientific excellence, technical expertise, and data integrity in area of responsibility. Remain abreast of new developments in the biosimilar field and build a strong reputation within the industry community.
- Ensure that biosimilar “mindset” and specialized requirements are communicated and adhered to by the dedicated internal and external resources.
- May serve as a member of biosimilar CMC teams.
- You shape and lead a team that independently designs and executes process development workstreams.
- Continually identify and implement process improvement and waste elimination opportunities to help create and maintain a lean, flexible, and agile manufacturing and development facility.
- Provide technical and scientific guidance to team members contributing to a multi-skilled and engaged upstream development team.
- Continually identify and implement process improvement and waste elimination opportunities to help create and maintain a lean, flexible, and agile manufacturing and development facility.
- You identify the risks related to process feasibility, manufacturability, timing, and resource constraints and develop remediation plans. Escalate any technical issues to the Technical Development Team.
- Build and sustain trust and transparency with key internal colleagues (across sites, Project Management, CMC, Regulatory Affairs, and Quality) and external customers (clients) to ensure engagement with the Biosimilars team objectives.
- Supervise and/or mentor team members.
- Knowledge, skills and abilities_:

- Expertise in Bioreactor design, process development and optimization for intensified and/perfusion processes for Biosimilars production.
- Expertise in process transfer to cGMP manufacturing plants, and authoring development summary reports, tech transfer reports and CMC sections of regulatory filings.
- Experience with commercial process development and process characterization for biosimilars.
- Experience in leading bioreactor development teams and collaborations as well as internal technology development initiatives.
- Expertise in design of experiments (DOE) and statistical analysis.
- Experience and education_:

- MS degree in Engineering, Biochemistry or related field and 15+ years of experience, or PhD with 7+ years of experience
- Other information_:

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

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Mission générale

Just - Evotec Biologics est à la recherche d'un Responsable Senior, Bioreactor Process Design pour rejoindre une équipe multidisciplinaire, collaborative et au rythme soutenu, afin de diriger des projets de développement en amont. Dans ce rôle, vous participerez au développement et à l'amélioration de la plateforme de biotraitement continu de nouvelle génération de Just, que nous utilisons actuellement dans nos usines de Seattle et de Redmond à l'échelle 500L et 1000L. Les employés de Just - Evotec sont motivés par notre mission : élargir l'accès aux thé