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Jobs · Management · New Jersey

Senior Director, Large Molecule, Analytical Development & QC

Insmed Incorporated · Bridgewater, NJ · 1 wk ago
On-siteManagement$214k–$292k/yrFull-time

About the role

We're seeking a Senior Director, Large Molecule, Analytical Development & QC to join our Technical Operations team. Reporting to the Executive Director, Analytical Development & QC, you'll shape and execute the analytical framework for large molecules. Your responsibilities include leading analytical activities, establishing comprehensive analytical approaches, ensuring alignment with regulatory standards, and supporting regulatory inspections.

Responsibilities

  • Provide strategic and operational leadership for analytical activities for developing, validating, and implementing analytical strategies (method development, validation, characterization, stability) for large molecule programs from early development to commercialization.
  • Ensure analytical approaches align with CMC development stages and evolving regulatory standards.
  • Partner 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 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, including installation, qualification, and lifecycle 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.
  • Leadership experience including training and mentoring other technical staff.
  • Hands-on experience using and interpreting data from various analytical techniques including chromatography, mass spectroscopy, SEC-MALS, and MS.
  • Strong statistical skills with a good understanding of basic and intermediate statistical tests.
  • Proven track record navigating regulatory expectations for biologics (FDA, EMA, ICH).
  • Excellent presentation skills both verbally and in writing.
  • Effective communicator and cross-functional collaborator with the ability to influence across technical and strategic levels.
  • 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.

Qualifications

  • Ph.D. in Chemistry, Biochemistry or related field with 5+ years of experience in the Biopharmaceutical industry.
  • Experience with SEC-MALS and MS.
  • Experience with Waters/Empower.
  • Experience with regulatory submissions and inspections.

Skills

  • Leadership and mentoring skills.
  • Technical expertise in biopharmaceutical analysis.
  • Strategic and operational leadership.
  • Collaboration with internal and external stakeholders.
  • Regulatory compliance and submission experience.
  • Statistical skills and proficiency in data interpretation.
  • Communication and presentation skills.
  • Attention to detail and analytical thinking.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and generous paid time off policies. We also provide fertility and family-forming benefits, caregiver support, and flexible work schedules. Additionally, we offer a 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. We also provide access to our Employee Assistance Program (EAP), skill-building workshops, leadership programs, mentorship connections, and networking opportunities. Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities.

Pay

$214,000.00 - $292,000.00 Annual

Schedule

This role is based out of our Bridgewater HQ or NJ RDL Lab and requires full-time, in-person presence to support hands-on collaboration, access specialized equipment, and/or operational needs. Travel requirements include frequent travel (up to 30%) for vendor relationships.

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