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.
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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
