Senior Director, Large Molecule, Analytical Development & QC
About The Position
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 program at Insmed from early development to Commercialization ensuring regulatory compliance (ICH, FDA, EMA) while managing internal/external labs and cross-functional collaborations.
Requirements
- 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 leadership experience including prior experience with training and mentoring other technical staff.
- 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 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 tool (Veeva , Trackwise).
- Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills.
Nice To Haves
- Experience with SEC-MALS and MS being advantageous.
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.
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- annual wellbeing reimbursement
- access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- fertility and family-forming benefits
- caregiver support
- flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- annual equity awards
- participation in our Employee Stock Purchase Plan (ESPP)
- 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
- meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Senior
