Aseptic Process Simulation Manager
5 days ago
Job Summary:
The Aseptic Process Simulation Manager will lead Aseptic Simulation studies from early planning, building strategies in a collaborative manner across internal disciplines and external partners and contractors. This role will support Aseptic Simulation Studies performing for Sterile Products and Bio-similar products at a nonprofit pharmaceutical company.
Key Responsibilities:
- Design and develop the Aseptic Process Simulation (APS) program for Aseptic and Biosimilar injectables.
- Conduct risk assessments and mitigate risks associated with aseptic processing operations.
- Manage the APS activities for sterile injectable vials, cartridges, pre fill syringes, and pens.
- Share knowledge and expertise with respect to start up and validation including utilities and equipment.
- Drive enhancement of sterile standards within the manufacturing environment.
- Investigate Deviations and conduct Root Cause Analysis.
- Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
- Support product preapproval inspection. The role has direct interaction with regulatory agencies during site inspections.
Requirements:
- Bachelor's degree in microbiology, engineering, or a related discipline.
- 8+ years in a sterile cGMP production environment.
- Direct experience with APS including knowledge of the requirements of Annex 1 and PDA technical reports.
- Direct Experience with sterile injectibles.
- Must have extensive hands-on experience in the development of aseptic programs including Clean Room Qualification, and Environmental Monitoring.
- Experience with biological production processes.
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
About Our Company:
Our client is a nonprofit pharmaceutical company founded in 2018, aimed at addressing drug shortages and providing essential medications at affordable prices. It focuses on manufacturing generic sterile injectables, particularly those used in hospitals. They collaborate with health systems and the government to ensure reliable access to critical medicines, helping to stabilize the supply chain and reduce dependence on expensive alternatives. The company prioritizes quality, reliability, and patient-centric outcomes in its production processes.
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