Associate Director, Drug Product Operations
Role Overview
The Associate Director, Drug Product Operations is a key team member of Drug Product and Device Operations and will be responsible for the oversight of drug product development and manufacturing activities. This position will work closely with cross-functional teams as well as external partners to ensure robust, compliant drug product manufacturing.
Core Responsibilities
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.
The Associate Director, Drug Product Operations is a key team member of Drug Product and Device Operations and will be responsible for the oversight of drug product development and manufacturing activities. This position will work closely with cross-functional teams as well as external partners to ensure robust, compliant drug product manufacturing.
Core Responsibilities
- Oversee design and execution of formulation studies, evaluation of alternate material and primary packaging components at the contract research organization (CRO).
- Support commercial manufacturing campaigns, deviations and change management at the existing manufacturing site.
- Lead drug product tech transfer activities to external manufacturing sites (CDMOs).
- Provide support responses to regulatory authority information requests. Author related sections for regulatory filings (IND, IMPD, BLA, PAS).
- Collaborate with Analytical, Drug Substance, Quality, Regulatory and Supply Chain teams to ensure timely release of the batches.
- Other projects, responsibilities and duties maybe assigned.
- Ph.D. in a related life sciences or chemical engineering discipline and 7+ years of related experience, or M.S. in a related life sciences or chemical engineering discipline and 10+ years of related experience, or B.S./B.A. in a related life sceiences or chemical engineering discipline and 12+ years of related work experience.
- Proven track record in drug product development and manufacturing.
- Experience in formulation development with preference in biologics & combination products.
- Experience with drug product tech transfer and manufacturing in late stage/commercial setting preferred.
- Experience to support regulatory filings and providing responses to agencies.
- Excellent verbal, written, and presentation communication skills, ability to work with cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and advocating compliance.
- Ability to deal with ambiguity, yet provide creative & pragmatic solutions.
- Ability to use expertise and skills to contribute to company objectives and principles, and to achieve goals in creative and effective manner.
- This role is remote and is based in the US.
- This role requires the ability to work in the US Eastern Time Zone.
- Highly competitive medical, dental, and vision coverage
- Flexible Spending Account for health care and dependent care expenses and Health Savings Account
- Paid time off and paid holidays, including Dec 24-Jan 1
- Paid parental leave
- 401(k) with highly competitive match
- Life, AD&D, STD and LTD insurance coverage
About Savara
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.