About the Company
Our client, a clinical-stage biotechnology company developing unique oncologic drugs treatments, is currently seeking a Manufacture Specialist (Technical Operations & CMC) to join their growing team. The upstream Manufacture Specialist will be a key member of the Technical Operations team with responsible for supporting our client’s R&D and clinical development programs that evolve to late stage.
- Developing cell culture and conjugation manufacture processes in support of first-in-class photoactivatable monoclonal antibody conjugates
- Internal material supply to support the development, and discovery programs.
- Technical transfer, development of manufacture processes and manufacturing activities and documentation at CMOs.
- Facility/plant fit analysis, scale-down cell culture pilot manufacture, authoring of process descriptions, author/review of manufacture batch records, person-in-plant manufacture support, authoring campaign summary report.
- Technical oversight and closure of process related Deviations and CAPAs internal and external manufacture.
- May be responsible for authoring and/or reviewing relevant IND/IMPD sections and generating responses to global regulatory agencies
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- A minimum of 10 + years of Biologics development and manufactured experience required; some experience process engineering preferred.
- Advanced degree preferred, MS and/or PhD. Desired
- Excellent communication and collaboration with support groups, including QA, QC, Manufacturing Operations, Regulatory Affairs, Supply Chain, Engineering, Biologics Outsourcing and Biologics Process Development is a must
- Experience with monoclonal antibody processes through development, clinical and commercial scales is required.
- Must have strong knowledge of cGMP manufacturing and associated regulatory requirements, including proven experience supporting process and facility/equipment sections of regulatory filings.