Manufacturing Science and Technology Director
2 weeks ago
A challenging role exists for an experienced professional to lead the transfer of sterile biologics production processes and technologies from R&D into site operations. Our client, Sterling Life Sciences, is seeking someone who can bring added value to the team. Responsibilities include:
Key Responsibilities:- Develop and implement biologics process control strategy documents, technology transfer change controls, and engineering 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.
- Oversee product technical lifecycle management, including process control strategy, process/yield improvement, and batch deviations.
- Support product pre-approval inspection, including direct interaction with regulatory agencies.
- Prepare and review cGMP documents, such as batch records, technical protocols, and reports.
- Work 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.
- Work with the Site Leadership Team to build subject matter expertise across functions.
- Perform gap assessment for new product introduction and provide innovative solutions.
- A university degree is required, preferably in a relevant field.
- Appropriate full-time work experience is mandatory.
- Recent experience in the pharmaceutical industry is strongly preferred.
- Preference will be given to candidates with recent experience in manufacturing management.
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Petersburg, United States Sterling Life Sciences Full timeJob Description Our client, a leading pharmaceutical company, is currently recruiting a Director of Manufacturing Sciences and Technology who will infuse the Director of Manufacturing Sciences and Technology Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative...
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Petersburg, United States Sterling Life Sciences Full timeJob OpportunityA challenging role exists for an experienced professional to lead the transfer of sterile biologics production processes and technologies from R&D into site operations. Our client, a leading pharmaceutical company, is seeking someone who can bring added value to the team.Key ResponsibilitiesDevelop and implement biologics process control...
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