Careers
Polynoma is currently not hiring.
Open Positions as of October 2023
Associate/Senior Process Development Scientist.
Overview
Polynoma is seeking a qualified individual to provide oversight of on-going process development and upcoming process characterization campaign for seviprotimut-L. The individual will provide strategic direction as to study design, execution and analysis and provide input to the Polynoma internal CMC team on final definition of the seviprotimut-L phase III/ commercial process. The individual will also provide oversight and strategic direction for the creation of new working cell banks to support the program as needed.
Summary of Key Responsibilities
- Provide oversight of upstream process development, cell banking and process characterization campaign at prospective external CDOs
- Design small scale experiments for execution at prospective CDOs to inform and justify necessary process changes to be implemented at manufacturing scale
- Coordinate transfer of process information, equipment, and materials as needed and provide oversight of Polynoma specific assets transferred
- Review and approve process development and process characterization documentation (plans, protocols, PD batch records and reports)
- Lead pFMEA sessions with prospective CDO and provide strategic direction of study designs based on analysis outcomes
- Analyze and interpret complex data derived from process characterization studies to identify appropriate CPPs, KPPs, NORs and PARs for the process
- Prepare recommendations for process changes and process control strategy definition based on outcomes of the process characterization campaign
- Assist Polynoma team and contract development site to draft and implement risk assessments, PPQ/validation strategy and monitor validation activities in preparation for commercialization of seviprotimut-L
- Assist Polynoma team with CMO oversight as needed (batch data, batch record, sampling plans, validation plans review, etc).
- This is a remote-based position and occasional travel to prospective or current CDO or CDMO sites will be required
Education Required
BS or MS degree in chemical/biochemical engineering or related life sciences discipline.
Experience / Skills Required
- 5+ years of experience in biologics or cell therapy USP process development and process characterization
- Familiarity with cGMP principles
- Experience with cultivation of adherent or primary human cell lines
- Experience in process validation design and execution and biologic product commercialization a plus
- Experience with technology transfer, bioreactor scaling up/down and scale-down model qualification
- Experience with QbD (Quality by Design) principles, statistical design and analysis of experiments
Compensation
Competitive compensation package commensurate with experience.
