Manufacturing Manager
1 month ago
A unique opportunity exists for an exceptional individual to lead the transfer of sterile biologics production processes and technologies from R&D into site operations.
Key Responsibilities:- Develop and implement biologics process control strategy documents, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D.
- Conduct process stewardship throughout the lifecycle management of commercial biologics manufacturing processes.
- Design a Process Performance Qualification plan to demonstrate manufacturing process performance as expected to initiate commercial manufacturing.
- Oversee product technical lifecycle management, including process control strategy, process knowledge management, batch deviations, and ensuring the accuracy of regulatory CMC registration details.
- Support product pre-approval inspections, including direct interaction with regulatory agencies during site inspections.
- Prepare and review cGMP documents, such as batch records, technical protocols, and reports, change controls, deviation reports, validation protocols, and summary reports.
- Collaborate with the Operations and Validation Team to prepare an aseptic core package for submissions.
- 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.
- Work with the Site Leadership Team to build subject matter expertise across functions in the areas of compounding, sterilization, and Single Use assemblies for filtration and filling, device assembly, and visual inspection.
- Work closely with the Operation and R&D Team to perform gap assessments for new product introductions and provide innovative solutions and develop a control strategy.
- A university degree is required, with preference given to those with degrees in a relevant field.
- Appropriate full-time work experience is mandatory, with no students or fresh graduates considered.
- Recent experience in the pharmaceutical industry is strongly preferred.
- Preference will be given to candidates with recent experience in manufacturing management.
A highly competitive package, commensurate with experience, is offered to the successful candidate.
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