Director, Quality Control

This role is considered Hybrid.

Job Summary

The Director of Quality Control Technical Services (QCTS) is responsible for providing enterprise level leadership and support for all late phase clinical and commercial QC programs. This includes providing direct ownership over specifications, reference materials and stability whose respective programs will need to continue to evolve in support of Alnylam's active pipeline and business needs. In addition, this individual supports the authoring/review of regulatory submissions and responses. They work closely with the analytical development team to assure continuity with method development, qualification, transfer and validation as phase appropriate. In addition, this role provides routine support & problem solving as the technical QC lead for Alnylam supporting internal, external and partner laboratories.

This position reports to the Sr. Director of Quality Operations and is located in Cambridge, MA.

Key Responsibilities

• Recruit, retain, train and develop a high-performing team responsible for the QC technical service programs. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and teams can excel and continuously improve.
• Manage the late phase clinical and commercial stability program via internal and external laboratories. This includes the authoring of stability protocols & reports, analyzing study data and providing continued support of the CMC program teams for any changes (e.g., expiry extensions).
• Responsible for all Alnylam specifications to include custom raw materials, drug substances and drug products across all markets. This includes authoring of specification justification reports and chairing the specification review board meetings.
• Maintain Alnylam's reference standard program to assure continued supply across internal/external laboratories.
• Author/Review regulatory submission sections (Module 3 of the CTD - Manufacturing Process and Control Information) and responses to questions from the regulatory review cycles.
• Provide technical leadership and support of internal and external laboratory operations as needed. Support analytical activities conducted at internal and external laboratories including method validations, method transfers and analytical investigations.
• Provide ownership over relevant governances and procedures to assure compliance/consistency to applicable regulatory standards (CFR, Eudralex), guidance documents (ICH Quality Guidelines) and pharmacopeia (USP/EP/JP).
• Additional duties as assigned.

Requirements

• Minimum, a BS degree in life sciences, engineering or related field. M.S. or Ph.D. preferred.
• Minimum of 8 years pharmaceutical quality assurance experience or analytical development role
• Relevant experience in managing complex small molecule purity/impurity profiles. Strong preference for prior oligonucleotide and/or organic chemistry expertise.
• Good understanding of FDA and EMA regulations and guidelines
• Excellent organizational, communication, and interpersonal skills.
• Proven ability for strategic enterprise thinking in a complex business environment.
• Ability to lead teams in dynamic situations.
• Ability to deal with ambiguity.
• Project management capabilities.
• Requires approximately <10% travel, both domestic and international.
• Close alignment with Alnylam's core values

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.