Sr. Manager/Associate Director of Drug Product CMC
New York
Permanent
USD160000 - USD210000
Research and Development
PR/589552_1778018926
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.
The organization is seeking a Senior Manager or Associate Director, CMC to lead and execute end-to-end Chemistry, Manufacturing & Controls activities for its commercial sterile injectable program. This individual will oversee drug product manufacturing, manage external manufacturing partners, support regulatory activities, and drive lifecycle management efforts to ensure consistent supply and continuous product enhancement on a global scale.
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