Senior Manager, Manufacturing


Job ID 19-00097

Industry Pharma

Job Type Permanent

Location Somerset, NJ

Description

Job description:
- Schedules production activities with the Director of Operations, according to sales orders.
- Conducts new production employee training according to current Standard Operation Procedures (SOP's) and General Manufacturing Procedures (GMP) requirements.
- Manages the following departments: Pharmacy, Compounding, Aseptic Filling, Packaging, Autoclaving and Cleaning Sanitization.
- Reviews filling and compounding operations to verify conformance with established specifications.
- Coordinates and manages the re-certification of aseptic manufacturing via media fills and smoke studies.
- Perform (in conjunction with the QA department) investigations within the manufacturing department. Must have an understanding of the TrackWise investigation system
- Develops departmental Standard Operating Procedures.
- Co-chair employee action committee.
- Assist in annual budgeting process and monthly department variance analysis.
- Must pass the gown certification process.
- Audits daily sterilization records, sanitization records and equipment log books.
- Performs production department intermediate and final batch record audits when required.
- Evaluation and purchase of production supplies and suppliers.
- Manage manufacturing personnel required to support aseptic filling and compounding activities during assigned shift.
- Interviewing, hiring, training, reviewing, and issuing disciplinary action, as necessary, for all manufacturing personnel.
- Interaction with Regulatory Agencies (FDA, DEA, OSHA) and contract clients.



Qualifications

Bachelor of Science degree and a minimum of five+ years related experience in an aseptic pharmaceutical environment is required. Must have experience managing employees. Extensive experience in aseptic behaviors and techniques is a must.