Formulation Filling Lyophilization Supervisor - for a leading Pharmaceutical Company
- Formulation Filling Lyophilization Supervisor
- Marietta, PA
A leading pharmaceutical production company is seeking a Formulation Filling Lyophilization Supervisor - who is genuine, talented, and collaborative to join their ever-growing team. Do you have Management, Supervisor, or Lead biotech manufacturing experience, or enjoy providing leadership, preparation, and resources to help create a high-functioning work environment? If you answered yes to any of these questions, enjoy being part company with a steady path of evolution and are looking to take your career to the next level, then apply now!
Summary:
The Formulation Filling Lyophilization Supervisor - will be responsible for supervising under guidance from manager and higher-level supervisory staff the aseptic buffer and vaccine formulation, vial filling lyophilizing, vial capping and vial inspection lines in secondary manufacturing operations to meet mandatory quality, compliance and delivery targets of process validation lots and commercial products. This role will also ensure manufacturing operations are completed in cGMP compliant manner and complies with company conformance standards and all pertinent regulations. Responsibilities also include managing the training and qualifications for staff to ensure all operating processes are followed and compliant with all company set standards and federal guidelines.
The Formulation Filling Lyophilization Supervisor - should have the following skill set:
- BS or BA in a biological, chemical science, or engineering or equivalent technical discipline
- 2+ years of pharmaceutical production experience in vaccines or biopharmaceuticals
- 2+ years in a role leading cross functional teams
- Preferred experience should include supervising and managing production including aseptic technique, filling, and lyophilization, and product visual inspection
- Prior user experience with planning software.
- Experience with cGMPs
- Full understanding of GMP's, and other applicable regulatory agency requirements
The Formulation Filling Lyophilization Supervisor - will:
- Oversee manufacturing processes, automation equipment and personnel to ensure quality operations.
- Manage product risk and escalate risks through site management, consult with manager
- Supervise the day to day activities of operations associates and Electro Mechanical Technicians performing aseptic buffer and vaccine formulation, filling, lyophilization, capping and inspection manufacturing operations.
- Organize resources required to complete routine work and assigned special projects in a timely manner.
- Aid and assist Process PQMP and PQ/PV Execution.
- Support the development and implementation of productivity improvement plans using Industrial Excellence methodologies.
- Examine and report progress of safety objectives, performance against schedule and number of defects.
- Pinpoint the cause of the problems and continue to educate staff on solutions, accident avoidance and error reductions.
- Assist the process for and troubleshoots process deviations and equipment failures.
- Perform job responsibilities in accordance with applicable EHS and GMP regulations
