Senior Director, Small molecule -Analytical development and QC

Insmed Incorporated

2d • $214,000 - $292,000 • Hybrid

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Senior Director, Small Molecule on the Analytical Development and Quality Control team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Analytical Development and QC you’ll provide strategic and operational leadership for analytical activities for developing, validating and implementing analytical strategies (method development, validation, characterization, stability) for small molecule programs at Insmed from early development to commercialization ensuring regulatory compliance (ICH, FDA, EMA) while managing internal/external labs. You’ll provide strategic leadership for the AD/QC organization by aligning analytical and QC strategies with broader CMC and corporate objectives and ensuring operational and compliance excellence.

Requirements

• You have 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.
• 5+ years of experience managing direct reports including prior experience with training and mentoring other technical staff
• Demonstrated leadership at Director or Senior Director level within GMP environment
• 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.
• Strong statistical skills with a good understanding of basic and intermediate statistical tests
• Proven track record navigating regulatory expectation (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 tool (Veeva, Trackwise)
• Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills
• Ability to manage multiple and competing priorities through effective organizational, people, and time management skills

Nice To Haves

• Experience with SEC-MALS and MS being advantageous

Responsibilities

• Oversee analytical activities conducted at contract laboratories.
• Manage relationships with CDMOs and external testing labs, ensuring timelines and quality standards are met
• Develop and implement analytical strategies for small molecule APIs and drug products across all development phases
• 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
• Serve as the analytical subject matter expert for regulatory submissions
• Lead the build out of new analytical laboratory, from concept to operational readiness including installation, Qualification and life cycle management of laboratory systems
• Drive continuous improvement initiatives to enhance data integrity, laboratory efficiency and compliance robustness
• Identify problems and challenges with deliverables and establish effective solutions in a timely manner to minimize disruption to project milestones
• Develop, motivate, and retain a high‑performing AD/QC team through structured goal‑setting, continuous coaching, targeted capability development, and active mentoring of scientific and managerial staff
• Ensure onboarding, training, and competency frameworks are fully implemented and periodically refreshed
• Lead departmental budgeting, capital planning, and resource allocation to support laboratory operations, instrumentation strategy, and staffing

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Director