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Open Positions as of March 2021
Senior/Principal Scientist or Engineer, Cell Culture.
Incumbent is responsible for technical management of all Polynoma cell culture development and upstream manufacturing operations to ensure the delivery of clinical drug substance – seviprotimut-L. Also, the Senior/Principal Scientist or Engineer is responsible for ensuring the technical success of cell banking and drug substance upstream processing conducted by third party vendors or contract development and manufacturing organizations (CDMO). In addition, Senior/Principal Scientist or Engineer will engage, manage and provide oversight of applicable CDMOs and other CMC-related vendors contracted by the Company.
Summary of Key Responsibilities
- Identify, vet, engage and develop best in class roster of CDMOs and third-party vendors used in the upstream manufacturing of clinical drug substance.
- Provide technical oversight and support for all cell culture development at CDMO and third-party sites.
- Ensure the development of cell banking and drug substance upstream processes are performed in a manner suitable for cGMP production.
- Develop and maintain strong and effective relationships with both internal and external parties to ensure corporate goals are met.
- Work with Polynoma team and contract manufacturers to develop and implement risk assessments, validation strategy, monitor validation activities in preparation for commercialization of seviprotimut-L.
- Serve as person in plant during key manufacturing steps.
- Support deviations, investigations and other documentation and follow-up, as appropriate.
- Draft, review, revise regulatory dossier sections and routine updates. Collect information from third party vendors as needed in support of these activities.
- Work closely with QC/QA, Operations, Regulatory, Document Control, Clinical and Finance departments, as well as contracted consultants and third-party vendors to ensure the safe, efficient and compliant delivery of drug substance to be used both in the research and clinical settings, and eventually for commercial use.
- Undergraduate degree in scientific field required. Advanced degree (MS or Ph.D.) desired.
- 10+ years experience working in cell line and cell culture development in a bio/Pharma company setting with a strong preference of experience/expertise working with human cancer cells, and 5+ years in biologics or cell therapy cGMP manufacturing.
- Experience in working with and managing Contract Development and Manufacturing Organizations (CDMO) and Contract Testing Organizations (CTO).
- Experience in the development of CMC documentation for regulatory dossiers preferred.
- Experience with the upstream cell culture manufacturing at commercial scale and/or for phase 3 clinical trials. Experience in process validation design and execution and biologic product commercialization a plus
Boston Area, East Coast preferred. Position is remote-based and will require some travel to Boston and Europe.
Salary commensurate with experience and expertise plus full benefits.