Director, Drug Product Development & Process Sciences

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

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.