Currently partnering with a global public biopharmaceutical company with an exciting and diverse portfolio of programs, seeking a Director of Drug Product to join their growing team. This is a high-impact role at the forefront of late-stage development and commercialization, focused mainly on their sterile, lyophilized injectable portfolio.
As Director of Drug Product, you will play a critical role in shaping development strategies for late-stage and commercial programs. You will lead cross-functional teams, author regulatory CMC documentation, and manage external partners and CMOs to ensure timely and high-quality delivery of drug product programs. This is an opportunity to influence pipeline success and directly contribute to bringing innovative medicines to patients worldwide.
Key Responsibilities
- Lead drug product development strategies for late-stage and commercial small-molecule programs
- Provide technical oversight for sterile, lyophilized injectables, ensuring robust manufacturing and formulation approaches
- Author CMC sections for regulatory submissions (IND, NDA, BLA) and contribute to regulatory interactions
- Collaborate with external partners, CDMOs, CMOs, and cross-functional teams to manage timelines, risks, and quality deliverables
- Mentor and develop team members, fostering a high-performing, innovative environment
Qualifications
- Degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field
- 8+ years of drug product development experience
- Preferably in sterile, lyophilized, or injectable products
- Demonstrated experience with late-stage and commercialization programs
- Strong project management, leadership, and communication skills
- Proven ability to drive complex programs with cross-functional and external stakeholders
Apply today to learn more or reach out directly -
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