Insmed Incorporated · 15 hours ago
Senior Director, Large Molecule, Analytical Development & QC
Headquarters, NJ
Full-time
Onsite
Director/Executive
$214K/yr - $292K/yr
15+ years expInsmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. The Senior Director will shape and execute the analytical framework for large molecules and provide strategic leadership for analytical activities, ensuring regulatory compliance and managing collaborations.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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. 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 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
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
Company
Insmed Incorporated
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases.
1001-5000 employees
H1B Sponsorship
Insmed Incorporated has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (6)
2023 (14)
2022 (8)
2021 (1)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$4.56BKey Investors
CureDuchenne Ventures
2025-06-11Post Ipo Equity· $750M
2024-05-30Post Ipo Equity· $650M
2023-05-08Post Ipo Equity· $0.5M
Leadership Team
Will Lewis
Chairman and Chief Executive officer
Walter R. Perkins
Chief Technology Officer
Recent News
2026-01-13
2026-01-11
Company data provided by crunchbase