Director, Product Development

Overview:

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

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 cGMP operational environment

Experience in preparing regulatory documents including briefing documents for regulatory meetings, INDs, and NDAsIn-depth understanding and hands-on experience in drug product formulation, process development and characterization

Hands-on experience in analytical methods for characterization of drug products and processes

Excellent leadership, organizational and communication skills

Demonstrated strong operational execution and problem-solving skills

Desire to work in a fast-paced, deadline-driven environment

If employed in the U.S., being fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) is required.

About Alnylam We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people.

We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic…