Director, Product Development

Alnylam Pharmaceuticals; Cambridge (MA); On-site; USD 210,000 - 320,000; Full time

Job summary

Alnylam Pharmaceuticals in Cambridge, MA, seeks a Director, Product Development (Process Sciences) to lead drug product process development, optimization, scale-up, characterization and pre-validation for RNAi therapies. You will guide cross-functional teams and external CMOs on development, transfer and oversight of manufacturing processes.

You will author regulatory documents, contribute to technical strategies, and represent Drug Product during regulatory interactions.

Qualifications

• PhD in a relevant field or MS with 16+ years in pharmaceutical process development.
• Demonstrated experience in process development and validation of sterile drug products and dosage forms.
• Experience leading drug product development teams and managing cGMP contract manufacturers.

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.

Skills

Process development

Process validation

cGMP

Cross-functional leadership

Regulatory collaboration

Education

Pharmaceutical sciences degree

Chemistry degree

Chemical engineering degree

Biochemical engineering degree

Job description

The Director, Product Development (Process Sciences) will lead process development, optimization, scale-up, process characterization and pre-validation for all RNAi drug products at Alnylam. The 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

Qualifications

• 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