Director, Product Development

Alnylam Pharmaceuticals Inc.; Cambridge (MA); On-site; USD 197,000 - 267,000; Full time

Job summary

Alnylam Pharmaceuticals Inc. is seeking a Director of Product Development (Process Sciences) to lead drug product development, optimization, and pre-validation for RNAi drug products in a fast-paced, collaborative environment.

You will author regulatory documents, oversee process transfer with contract manufacturers, and drive strategic technical discussions with internal teams and external partners. Travel to sites will be 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 with regulatory, quality, clinical, project management, legal, finance, and supply chain functions in a cGMP environment.
• Experience in preparing regulatory documents including briefing documents for regulatory meetings, INDs, and NDAs.
• Hands-on experience in drug product formulation, process development and characterization.
• Excellent leadership, organizational and communication skills.

Responsibilities

• Lead drug product and process development, optimization, scale-up, characterization and pre-validation
• Author and review technical protocols and reports for late phase manufacture and process characterization
• Lead preparation of Drug Product sections of regulatory filings and interact with regulatory authorities
• Contribute to strategic technical discussions and present progress at meetings
• Represent Drug Product development on cross-functional teams including contract manufacturing
• Integrate Drug Product activities with other CMC functions (Drug Substance, Analytical Development, QA, Regulatory)
• Travel periodically to manufacturing and partner sites

Skills

Leadership

Cross-functional collaboration

Regulatory interaction

Project management

Communication

Problem solving

Education

PhD in Pharmaceutical Sciences / Chemistry / Chemical Engineering

MS with 16+ years experience in pharmaceutical process development

Job description

Overview: 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 cGMP operational environment
• Experience in preparing regulatory documents including briefing documents for regulatory meetings, INDs, and NDAs
• In-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 information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.

Before applying, please review Alnylam's Candidate Privacy Notice regarding how Alnylam handles Personal Data you provide with your application for employment.

The pay range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam’s robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website: https://www.alnylam.com/careers

U.S. Pay Range

$197,100 — $266,700 USD