Sr. Manager/Associate Director of Drug Product CMC
We are partnered with a commercial-stage biopharma who is focused on advancing supportive care and improving quality of life for oncology patients. Its primary marketed product is an FDA-approved sterile injectable therapy. Launched in the U.S. in recent years, this intravenous product addresses a clear unmet need in oncology supportive care, with ongoing initiatives aimed at expanding both clinical utilization and international presence.
Key Responsibilities
- Lead CMC activities for sterile injectable products, including drug product manufacturing, fill/finish operations, and commercial supply
- Manage CDMO relationships, overseeing performance, timelines, tech transfer, and issue resolution
- Support lifecycle management, including process validation, process improvements, and change control
- Contribute to regulatory submissions (INDs, NDAs, 505(b)(2), and global equivalents), including authoring/review of CMC sections - prior experience would be a plus
- Partner cross-functionally with Quality, Regulatory, Supply Chain, and Clinical teams to ensure alignment on development and commercial strategy
- Drive manufacturing readiness and supply planning, ensuring uninterrupted product availability
- Oversee investigations, deviations, and CAPAs in collaboration with Quality and external partners
- Provide technical oversight for analytical development, specifications, and stability programs
- Support inspections and audits (FDA, EMA, and other regulatory agencies)
Qualifications
- BS/MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline (Pharmaceutical Sciences strongly preferred) w/ 6-8+ years (Sr. Manager) / 8-10+ years (AD) of experience in CMC, with a focus on sterile injectable products
- Demonstrated experience with aseptic processing, fill/finish, and sterile manufacturing operations
- Strong knowledge of cGMP regulations and global CMC requirements
- Experience managing external manufacturing partners (CDMOs)
- Proven track record supporting regulatory filings and approvals
- Familiarity with commercial-stage products and post-approval lifecycle management highly preferred
- Strong communication and cross-functional leadership skills
Preferred Experience
- Background in small molecule sterile injectables
- Prior exposure to oncology or supportive care products is a plus
- Experience working in lean or small biotech environments, with high ownership and visibility
Why This Role
- Opportunity to play a high-impact role in a lean, commercially active organization
- Direct visibility into end-to-end CMC strategy and execution
- Collaborative environment with close interaction across executive leadership and key partners
- Ability to influence ongoing lifecycle management and future pipeline expansion
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