Executive Director overseeing effective leadership and operations at LucidHealth radiology practices. Responsible for implementing policies, strategies, and relationship management with practice leaders.
About the role
- Senior Director guiding analytical framework for large molecule programs at Insmed. Leading teams and ensuring regulatory compliance from early development to commercialization.
Responsibilities
- Shape and execute the analytical framework for large molecules
- 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)
- Manage internal/external labs and cross-functional collaborations
- 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
- 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 tools (Veeva, Trackwise)
- Highly organized, with sharp attention to detail, analytical thinking, and strong decision-making skills.
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
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