Manager, Manufacturing Science & Technology
Insmed Incorporated
August 06, 2026
Remote
United States
Operations
About The Role
Manager, Manufacturing Science & Technology (Manufacturing team). Reporting to the Associate Director, Manufacturing Sciences & Technology, support external manufacturing partners to bring rAAV-based therapies to market. Serve as a technical bridge between Process Development, CMC, and GMP manufacturing to ensure process robustness, technology transfer, and manufacturing excellence across development and commercial stages.
Responsibilities
- Lead and execute end-to-end technology transfer from process development through commercial-scale GMP manufacturing (facility fit assessments; process start-up coordination).
- Review critical documentation (pre/post-execution batch records, SOPs, raw material specs, development reports, GMP protocols).
- Act as person-in-plant during production campaigns; provide real-time support to maintain process parameters and quality standards.
- Perform process monitoring, data trending, and support process improvement for Drug Substance and Drug Product manufacturing.
- Drive timely closure of process deviations in Veeva with cross-functional teams; ensure compliance and traceability via document management systems.
- Support change control for process versions and process comparability assessments.
- Support process characterization and Process Performance Qualification (PPQ).
- Provide technical support for MSAT initiatives (e.g., SOW review/submission) and contribute to supply chain risk mitigation.
Qualifications
- Bachelor’s degree + 5 years relevant experience in Biotechnology, Chemical Engineering, Pharmaceutical Engineering, or related field.
- Solid technical background in upstream cell culture (suspension HEK293) and/or downstream purification; and/or drug product operations.
- Hands-on experience with GMP manufacturing, process validation, and tech transfer.
- Experience supporting gene therapy regulatory requirements (early and late phases).
- Strong interpersonal skills; ability to work independently and in a fast-paced, multidisciplinary environment.
- Strong verbal and written communication.
Nice to Have
- Expertise of drug product fill process.
Work/Travel
- Fully remote; occasional travel for team meetings/events.
- Frequent global travel (up to 40%) to CDMO sites.
Pay Range
- $127,000.00–165,500.00 annual.
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday.
Manager, Manufacturing Science & Technology (Manufacturing team). Reporting to the Associate Director, Manufacturing Sciences & Technology, support external manufacturing partners to bring rAAV-based therapies to market. Serve as a technical bridge between Process Development, CMC, and GMP manufacturing to ensure process robustness, technology transfer, and manufacturing excellence across development and commercial stages.
Responsibilities
- Lead and execute end-to-end technology transfer from process development through commercial-scale GMP manufacturing (facility fit assessments; process start-up coordination).
- Review critical documentation (pre/post-execution batch records, SOPs, raw material specs, development reports, GMP protocols).
- Act as person-in-plant during production campaigns; provide real-time support to maintain process parameters and quality standards.
- Perform process monitoring, data trending, and support process improvement for Drug Substance and Drug Product manufacturing.
- Drive timely closure of process deviations in Veeva with cross-functional teams; ensure compliance and traceability via document management systems.
- Support change control for process versions and process comparability assessments.
- Support process characterization and Process Performance Qualification (PPQ).
- Provide technical support for MSAT initiatives (e.g., SOW review/submission) and contribute to supply chain risk mitigation.
Qualifications
- Bachelor’s degree + 5 years relevant experience in Biotechnology, Chemical Engineering, Pharmaceutical Engineering, or related field.
- Solid technical background in upstream cell culture (suspension HEK293) and/or downstream purification; and/or drug product operations.
- Hands-on experience with GMP manufacturing, process validation, and tech transfer.
- Experience supporting gene therapy regulatory requirements (early and late phases).
- Strong interpersonal skills; ability to work independently and in a fast-paced, multidisciplinary environment.
- Strong verbal and written communication.
Nice to Have
- Expertise of drug product fill process.
Work/Travel
- Fully remote; occasional travel for team meetings/events.
- Frequent global travel (up to 40%) to CDMO sites.
Pay Range
- $127,000.00–165,500.00 annual.
Application Instructions
- Current Insmed employees: apply via Jobs Hub in Workday.