Quality Product Manager - Biotechnology
Biotechnology company specializing in antibody engineering for cancer treatment
About Our Client
This client is a rapidly growing biotechnology company based in the Waltham MA area which has recently raise $100 million in funding. The company specializes in next generation antibody engineering used for cancer treatment and has a lead drug in phase 3 of clinical studies.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
- Perform batch review and disposition of antibody, payload, linker, drug substance and drug product batches manufactured and tested by company CMOs and CTLs
- Partner with relevant internal and external teams to highlight potential quality issues during process transfer, GMP manufacturing and testing and identify/execute strategies to effectively manage them.
- Acquire and maintain end-to-end product knowledge enabling a contextual understanding of designated product(s) from clinical development through commercialization.
- Collaborate with key CMC stakeholders on development of the overall control strategy (e.g., in-process, release, stability testing and respective acceptance criteria).
- Draft and obtain approval of the intermediate, drug substance and drug product specifications. Contribute to the Specification and Stability Review Boards.
- Monitor compliance to respective Quality Agreements and escalate issues.
- Review and approve process validation protocols and reports, as well as master batch records and associated GMP documents used by company contractors.
The Successful Applicant
- Bachelor's degree in Life Sciences required
- Eight (8) years of biotechnology or pharmaceuticals experience in a GMP environment
- Experience with third party manufacturers and testing laboratories
- Must have working knowledge of batch release processes (assessment of batch data, deviations, investigations, change controls, complaints, etc.).
- Must have knowledge of process validation
What's on Offer
- Competitive base salary
- Annual bonus and other incentives
- Excellent full benefits package
- Growth opportunity
- Reports up to executive leadership of a rapidly growing biotech company
- Significant company funding
- Novel drug portfolio with strong pipeline