Manager, Manufacturing Science and Technology

Application Deadline: 29 January 2025

Department: Manufacturing - Reagent

Location: Wilmington, MA

Description

We 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.