Associate Director, Specifications

This role is considered On-Site.

Overview

The Associate Director, Specification will be responsible for proposing and implementing release and stability specification for early development siRNA drug substances, drug products, placebos, and diluents. The role will be accountable for assisting with regulatory submission specification sections, and provide inter-departmental support by ensuring life-cycle management of specifications internally and at contract manufacturers. The Associate Director, Specification will also be responsible for leading a team.

This position is onsite and will be primarily located in our Cambridge, MA office.

Key Responsibilities

• Lead Specification Review Board (SRB) meetings and moderate the discussions.
• Research available options and propose strategy for DS and DP specifications for early development programs. Transition these to Commercial Quality in late (Phase III) stage.
• Present specifications to the CMC team for alignment and to SRB for endorsement.
• Participate and represent at cross-functional meetings.
• Interact directly with internal and external auditors/inspectors from regulatory agencies and partners.
• Author technical reports in support of proposed specifications.
• Oversee initiation and completion of specification change controls.
• Manage changes throughout product life cycle.
• Author specification sections for regulatory submissions and respond to regulatory agencies/partners inquiries.
• Provide effective leadership to team through goal setting and performance reviews, managing employee development, meaningful hires, and supporting workforce engagement and diversity.
• Develop training materials and undertake training of new and existing personnel as required.

Qualifications

• M.S. or Ph.D. in Chemistry, Biochemistry, Pharmacology or related discipline.
• Minimum of 8 years experience in analytical testing for biopharmaceutical or pharmaceutical industry to include 4+ years of relevant experience in specification. Previous Quality Control / GMP experience is highly preferred.
• Strong skills in the application of statistical methods.
• Preferred experience with LC and physico-chemical test methods of oligonucleotides. Alternatively, experience with LC and physico-chemical test methods of oligosaccharides or proteins.

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.