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Director, Product Development
Job in
Cambridge, Middlesex County, Massachusetts, 02140, USA
Listed on 2026-10-12
Listing for:
Alnylam Pharmaceuticals
Full Time
position Listed on 2026-10-12
Job specializations:
-
Pharmaceutical
Pharmaceutical Manufacturing, Pharma Engineer, Validation Engineer, Pharmaceutical Science/ Research
Job Description & How to Apply Below
The Director, Product Development (Process Sciences) will lead process development, optimization, scale-up, process characterization and pre-validation for all RNAi drug products successful candidate will work closely with cross-functional teams and contract manufacturing organizations on drug product process development, characterization, process transfer and oversight of manufacturing processes.
Key Responsibilities- Lead drug product and process development, optimization, scale-up, characterization and pre-validation
- Author and review technical protocols and reports in support of late phase manufacture and process characterization activities
- Lead the preparation of the Drug Product section of regulatory filings and effectively represent the Drug Product function in interactions with regulatory authorities
- Contribute to strategic technical discussions and present progress at internal and external scientific meetings
- Effectively represent Drug Product development on cross-functional teams including internal program teams and externally with contract manufacturing and/or corporate partners
- Effectively integrate Drug Product activities with other CMC functions, including Drug Substance Development & Manufacturing, Analytical Development, Quality Assurance, and Regulatory Affairs
- Periodic travel to manufacturing and other partner sites is required
- Degree in pharmaceutical sciences, chemistry, chemical engineering, biochemical engineering
- Ph.D. or MS degree with 16+ years’ experience in pharmaceutical process development
- Demonstrated experience in process development and process validation of sterile drug products and dosage forms across multiple development projects including process transfer and management of cGMP contract manufacturing.
- Demonstrated management experience of successful drug product process development teams
- Experience working in close collaboration with technical, regulatory, quality, clinical, project management, legal, finance, and supply chain functions in a cG
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