Associate Director, Process Sciences

This role is considered On-Site.

Overview

The Associate Director, Process Sciences will be a member of the Process Transfer and Validation group. Responsibilities will focus on drug substances and will include process transfer to external and internal CMOs, process development, support of non-GMP manufacturing, early stage GMP manufacturing support, and Stage 1 process validation of oligonucleotide-based APIs.

This position is onsite and will be primarily located at our Kendall Square offices in Cambridge, MA.

Key Responsibilities

• Lead Technology Transfer Projects, including planning, coordination, and execution of technology transfer projects to/from internal sites and CMOs, encompassing process documentation review, process fit assessment, and batch record review.
• Clinical Material Manufacturing: Work closely with cross-functional teams (R&D, Quality, AD, Supply Chain, Regulatory, etc.) to ensure seamless coordination and successful execution of manufacturing projects.
• CMO Relationship Management: Cultivate relationships with CMO partners, facilitating effective collaboration to ensure alignment on project goals, timelines, and deliverables.
• Technical Support and Oversight: Provide technical expertise and guidance to CMOs during ongoing GMP manufacturing, and support of manufacturing excursions.
• Documentation: Authoring, review, and approval of technical documentation, including process development reports, process flow descriptions, campaign summary reports, batch records, change controls, SOPs, and data verification, ensuring compliance with internal procedures.
• Continuous Improvement: Support initiatives aimed at enhancing the efficiency, robustness, and cost-effectiveness of manufacturing processes at internal and external manufacturing sites, including manufacturing process development, optimization and scale up activities.
• Regulatory Filings: Drafting CMC sections in regulatory filings, including chemistry, manufacturing, and controls sections.
• Support Quality Assurance and Regulatory Affairs teams to ensure that all process transfer activities and CMO operations adhere to relevant industry standards.
• Domestic or International travel (10%) may be required.

Qualifications

• Ph.D. with a minimum of 6 years of relevant industry experience in GMP manufacturing of API.
• Technical expertise in solid phase oligonucleotide synthesis and relevant analytical, purification and downstream processing techniques.
• Demonstrated ability to manage multiple concurrent timelines and collaboration with cross-functional teams.
• Experience and thorough understanding of process development, technology transfer, process scale-up.
• Ability to integrate scientific findings/results across multiple research areas or development projects.
• Experience with large scale manufacturing of oligonucleotides, oligonucleotide-conjugates or comparable biopolymers is a plus.
• Proficiency in authoring, reviewing and execution of manufacturing and process development documentation.
• Good verbal and written communication.

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.