Associate Director, Process Sciences

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 isonsite and will be primarily located at our Kendall Square offices in Cambridge, MA.

Key Responsibilities

• Lead Technology Transfer Projects, includingplanning, 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:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.