Manager, Manufacturing Science and Technology
T2 Biosystems
Manager, Manufacturing Science and Technology
DescriptionWe are seeking an experienced technical leader to teach and supervise a small team responsible for the production of reagents and related materials. This position is based in Wilmington, MA and will report directly to the Vice President of Operations.
Responsibilities Supervise a team of technical manufacturing associates and direct the execution of reagent manufacturing processes in alignment with internal and external product demand and quality standards. Execute validation strategies for reagent manufacturing processes. Perform Batch Record reviews with assistance from team group leaders. Develop and execute process improvements for reagent manufacturing. Participate in on-the-floor manufacturing activities and become a subject matter expert in existing and new reagent manufacturing processes. Support established manufacturing processes and troubleshoot technical issues. Assist in the development of integrated schedules that facilitate production, release testing, and R&D testing when required. Support implementation of new manufacturing equipment and processes. Ensure the manufacturing team follows industry compliance standards (cGMP, FDA, ISO) for the formulation, fill, and finish of reagent trays. Work with Engineering throughout the execution of IQ, OQ, and PQ of equipment to support process development. Support NCR and CAR investigations. Support/manage sustaining activities and contribute towards cost reduction programs. Communicate product status to management as needed. Maintain lot traces of products and production schedule. Drive tech transfer activities as necessary. Conduct and oversee internal shipments between manufacturing-quality-operations departments. Perform and oversee inventory transactions to maintain inventory integrity.
Skills and Experience BS in a scientific or engineering discipline with relevant training and experience required. 5-7 years of manufacturing experience in an FDA-regulated, medical device/in vitro diagnostic, commercial-stage environment required. Experience with ERP systems applied to a manufacturing environment. Oracle experience a plus. Experience leading a highly-technical, collaborative and engaged manufacturing team required. Experience driving process improvements. Excellent organizational, recordkeeping, communication (verbal and written) and technical training skills. Experience with standards and working within a cleanroom environment. Strong work ethic and commitment to achieving/exceeding quality standards is required.
Application Deadline: 29 January 2025
Department: Manufacturing - Reagent
Employment Type: Full Time
Location: Wilmington, MA
Reporting To: Joseph Traut
DescriptionWe are seeking an experienced technical leader to teach and supervise a small team responsible for the production of reagents and related materials. This position is based in Wilmington, MA and will report directly to the Vice President of Operations.
Responsibilities Supervise a team of technical manufacturing associates and direct the execution of reagent manufacturing processes in alignment with internal and external product demand and quality standards. Execute validation strategies for reagent manufacturing processes. Perform Batch Record reviews with assistance from team group leaders. Develop and execute process improvements for reagent manufacturing. Participate in on-the-floor manufacturing activities and become a subject matter expert in existing and new reagent manufacturing processes. Support established manufacturing processes and troubleshoot technical issues. Assist in the development of integrated schedules that facilitate production, release testing, and R&D testing when required. Support implementation of new manufacturing equipment and processes. Ensure the manufacturing team follows industry compliance standards (cGMP, FDA, ISO) for the formulation, fill, and finish of reagent trays. Work with Engineering throughout the execution of IQ, OQ, and PQ of equipment to support process development. Support NCR and CAR investigations. Support/manage sustaining activities and contribute towards cost reduction programs. Communicate product status to management as needed. Maintain lot traces of products and production schedule. Drive tech transfer activities as necessary. Conduct and oversee internal shipments between manufacturing-quality-operations departments. Perform and oversee inventory transactions to maintain inventory integrity.
Skills and Experience BS in a scientific or engineering discipline with relevant training and experience required. 5-7 years of manufacturing experience in an FDA-regulated, medical device/in vitro diagnostic, commercial-stage environment required. Experience with ERP systems applied to a manufacturing environment. Oracle experience a plus. Experience leading a highly-technical, collaborative and engaged manufacturing team required. Experience driving process improvements. Excellent organizational, recordkeeping, communication (verbal and written) and technical training skills. Experience with standards and working within a cleanroom environment. Strong work ethic and commitment to achieving/exceeding quality standards is required.
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