Senior Director, Large Molecule, Analytical Development & QC
Insmed Incorporated
2 hours ago
On-site
Bridgewater, NJ
Operations
Senior Director, Large Molecule, Analytical Development & QC (Technical Operations)
Responsibilities
- Shape and execute the analytical framework for large molecules.
- Provide strategic and operational leadership for analytical activities including method development, validation, characterization, and stability.
- Develop, validate, and implement analytical strategies for large-molecule programs from early development through commercialization, ensuring regulatory compliance (ICH, FDA, EMA).
- Build and lead multidisciplinary Analytical Development and QC teams.
- Oversee analytical activities conducted at contract laboratories.
- Establish comprehensive analytical approaches integrating characterization, method development/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 with internal/external stakeholders.
- Partner with Process Development, Manufacturing, Quality Assurance, and Regulatory to align analytical plans with program objectives.
- Prepare for regulatory inspections by ensuring analytical systems, documentation, and practices are inspection-ready.
- Oversee out-of-specification and non-conformance investigations; provide analytical input to deviations, root cause analyses, and CAPA.
- Contribute to CMC/Technical Operations process and quality culture.
- Lead buildout of a new analytical laboratory (installation, qualification, and life cycle management).
Qualifications
- B.S. or M.S. in Chemistry, Biochemistry, or related discipline with 15+ years of biopharmaceutical experience; or PhD with 5+ years of biopharmaceutical experience.
Skills/Experience (Preferred/Required)
- 5+ years of leadership experience, including training and mentoring technical staff.
- Hands-on experience interpreting data from chromatography (HPLC/UPLC/SEC/GC) and mass spectroscopy (LC-MS/GC-MS); Waters/Empower preferred; SEC-MALS and MS advantageous.
- Strong statistical skills (basic and intermediate statistical tests).
- Proven track record navigating FDA/EMA/ICH regulatory expectations for biologics.
- Excellent verbal and written presentation skills.
- Effective cross-functional communicator with ability to influence technical and strategic levels.
- Proficient with Microsoft Office (Word, Excel, PowerPoint, Outlook) and quality system tools (Veeva, Trackwise).
- Highly organized with strong attention to detail, analytical thinking, and decision-making.
Work Location/Travel
- Bridgewater HQ or NJ RDL Lab; full-time, in-person.
- Frequent travel up to 30% for vendor relationships.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.
Responsibilities
- Shape and execute the analytical framework for large molecules.
- Provide strategic and operational leadership for analytical activities including method development, validation, characterization, and stability.
- Develop, validate, and implement analytical strategies for large-molecule programs from early development through commercialization, ensuring regulatory compliance (ICH, FDA, EMA).
- Build and lead multidisciplinary Analytical Development and QC teams.
- Oversee analytical activities conducted at contract laboratories.
- Establish comprehensive analytical approaches integrating characterization, method development/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 with internal/external stakeholders.
- Partner with Process Development, Manufacturing, Quality Assurance, and Regulatory to align analytical plans with program objectives.
- Prepare for regulatory inspections by ensuring analytical systems, documentation, and practices are inspection-ready.
- Oversee out-of-specification and non-conformance investigations; provide analytical input to deviations, root cause analyses, and CAPA.
- Contribute to CMC/Technical Operations process and quality culture.
- Lead buildout of a new analytical laboratory (installation, qualification, and life cycle management).
Qualifications
- B.S. or M.S. in Chemistry, Biochemistry, or related discipline with 15+ years of biopharmaceutical experience; or PhD with 5+ years of biopharmaceutical experience.
Skills/Experience (Preferred/Required)
- 5+ years of leadership experience, including training and mentoring technical staff.
- Hands-on experience interpreting data from chromatography (HPLC/UPLC/SEC/GC) and mass spectroscopy (LC-MS/GC-MS); Waters/Empower preferred; SEC-MALS and MS advantageous.
- Strong statistical skills (basic and intermediate statistical tests).
- Proven track record navigating FDA/EMA/ICH regulatory expectations for biologics.
- Excellent verbal and written presentation skills.
- Effective cross-functional communicator with ability to influence technical and strategic levels.
- Proficient with Microsoft Office (Word, Excel, PowerPoint, Outlook) and quality system tools (Veeva, Trackwise).
- Highly organized with strong attention to detail, analytical thinking, and decision-making.
Work Location/Travel
- Bridgewater HQ or NJ RDL Lab; full-time, in-person.
- Frequent travel up to 30% for vendor relationships.
Application Instructions
- Current Insmed employees: apply via the Jobs Hub in Workday.