Location: Bedford, MA
The Manufacturing Supervisor is responsible for providing leadership in the production of clinical and commercial drug product and injectable medical devices. Supervision includes aseptic and terminal sterilized processes involving compounding, filtration, organic synthesis, formulation, and filling operations in a cleanroom environment.
Strategic Focus Areas:
The position drives continuous improvement in the areas of safety, quality, compliance, on time in full delivery and staff involvement. The Supervisor will actively participate in projects advancing site operations.
Specific Tactical Responsibilities:
- Prepare job schedules and assigns duties for a team of 10 -15 production personnel.
- Attends daily production meetings providing schedule adherence metrics and required cross functional support to meet manufacturing goals.
- Maintains procedures to ensure content is current and clear.
- Ensures employee training is adequate. Provides feedback and direction to personnel regarding their skill development.
- Completes root cause investigations, corrective actions and exception management reports with Quality Assurance support.
- Performs project related activities with Engineering involving process improvements, proof of concept pilot scale batches, and technology transfer.
- Completes material transactions, cycle counts and physical inventory activities. Actively resolves inventory issues and transactional errors with Supply Chain management.
- Coordinates all maintenance and calibration activities with Facilities management.
- Conducts performance management activities taking appropriate action when required.
- Maintains accurate records of employee time sheets for financial reporting.
The Manufacturing Supervisor has the primary responsibility for aseptic manufacturing and delivery of product meeting internal and external customer expectations. Erroneous or mistimed decisions may cause an unfavorable impact to the business. The job entails strong analytical, aseptic technique, leadership and team-building skills.
Responsible for front line supervision of floor personnel and projects.
- Bachelor’s degree in the life sciences, Chemical Engineering or Chemistry preferred.
- Minimum of 5 years of cGMP experience in an aseptic environment in a leadership role.
- At least 3 years of experience with Materials Requirement Planning transactions and reporting
- Thorough knowledge of applied pharmaceutical and/or medical device GMPs in a commercial manufacturing operation involving process improvements and cost savings
- Demonstrated experience as a floor change agent implementing manufacturing process improvements.
Desired Experience, Knowledge, and Skills:
- Direct participation in Regulatory and Quality inspections/walkthroughs.
- Experience validating aseptic manufacturing equipment and processes
- Ability to solve aseptic problems and deal with a variety of situations where critical thinking and problem solving is required.
- Budgetary experience involving the tracking and managing of departmental expenses.
- Experience using software such as SAP and Microsoft Office.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.