Managing Director leading the NFTC Foundation’s initiatives on U.S. global economic leadership. Driving campaigns, managing resources, and collaborating with stakeholders in policy and trade affairs.
About the role
- Senior Director, small molecule leading analytical development and QC for biopharmaceutical company Insmed. Driving strategies and ensuring regulatory compliance for developing small molecule programs.
Responsibilities
- Provide strategic and operational leadership for analytical activities for developing, validating and implementing analytical strategies (method development, validation, characterization, stability) for small molecule programs
- Oversee analytical activities conducted at contract laboratories
- Manage relationships with CDMOs and external testing labs
- 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
- Support regulatory inspections by ensuring analytical systems, documentation and practices are ready for inspection
- Oversee out-of-specification and non-conformance investigations
- Provide analytical input to deviation, root cause analyses, and CAPA development
- Lead the build out of new analytical laboratory, from concept to operational readiness
- Drive continuous improvement initiatives to enhance data integrity, laboratory efficiency and compliance robustness
- 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.
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 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.
- 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 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.
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
- 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
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