Senior Director, Large Molecule, Analytical Development & QC

About the role

We're looking for a Senior Director, Large Molecule, Analytical Development & QC on the Technical Operations team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, Analytical Development & QC, you'll be responsible for shaping and executing the analytical framework for large molecules. As well, you will provide strategic and operational leadership for analytical activities for developing, validating, and implementing analytical strategies (method development, validation, characterization, stability) for large molecule programs at Insmed from early development to Commercialization ensuring regulatory compliance (ICH, FDA, EMA) while managing internal/external labs and cross-functional collaborations.

Responsibilities

• Build and lead multidisciplinary Analytical Development and QC teams.
• Oversee analytical activities conducted at contract laboratories.
• Establish a comprehensive analytical approach for large-molecule programs, integrating characterization, method development, method validation, release and stability testing for drug substance and drug product.
• Ensure analytical approaches align with CMC development stage and evolving regulatory standards. Provide technical leadership in collaboration with internal and external stakeholders.
• Partner closely with Process Development, Manufacturing, Quality Assurance, and Regulatory functions to align analytical plans with overall program objectives.
• Support regulatory inspections by ensuring analytical systems, documentation and practices are ready for inspection.
• Oversee the out-of-specification and non-conformance investigations. Provide analytical input to deviation, root cause analyses, and CAPA development.
• Serve as a key member of the CMC/Technical Operations team, contributing to organizational process and quality culture.
• Lead the build out of new analytical laboratory, from concept to operational readiness including installation, Qualification and life cycle management of laboratory systems.

Requirements

• A B.S or M.S. in Chemistry, Biochemistry or related discipline with 15+ years of experience or PhD with 5+ years of experience in the Biopharmaceutical industry.
• Hands on experience using and interpreting data from various analytical techniques including but not limited to chromatography (HPLC, UPLC, SEC, GC, etc.), mass spectroscopy (LC-MS, GC-MS, etc.); experience with Waters/Empower is preferred. Experience with SEC-MALS and MS being advantageous.
• Strong statistical skills with a good understanding of basic and intermediate statistical tests.
• Proven track record navigating regulatory expectations for biologics (FDA, EMA, ICH).
• Excellent presentation skills both verbal and written.
• Effective communicator and cross-functional collaborator with the ability to influence across technical and strategic levels.
• Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook) and quality system tools (Veeva, Trackwise).
• Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills.

Qualifications

• Leadership experience including prior experience with training and mentoring other technical staff.
• Experience with regulatory compliance and CAPA development.
• Knowledge of regulatory guidelines and standards for biologics (ICH, FDA, EMA).
• Ability to manage cross-functional teams and collaborate with internal and external stakeholders.
• Experience with laboratory operations, including installation, qualification, and life cycle management of laboratory systems.

Skills

• Expertise in analytical techniques for large molecules.
• Strong statistical and data interpretation skills.
• Experience with regulatory submissions and inspections.
• Effective communication and collaboration skills.
• Proficiency in Microsoft Office and quality system tools.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support.
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and participation in the Employee Stock Purchase Plan (ESPP).
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.

Pay

$214,000.00-292,000.00 Annual