Manufacturing Manager
3 days ago
Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States.
Our mission is to ensure that patients have access to affordable, high-quality medications. We achieve this by developing and manufacturing essential generic medications, partnering with healthcare systems and pharmacies to reduce costs, and advocating for policy changes that promote access to affordable medications.
Job Description:Manager, Manufacturing, Science and Technology (MSAT)The Manager, MSAT will lead the technical transfer and process support activities for New Product Introduction for the Civica Rx Petersburg site. Reporting to the Director, MSAT, you will work with Civica's manufacturing and engineering teams and lead technology transfers.
Key Responsibilities:
- Lead the transfer of production processes and technologies from R&D into site operations.
- Develop process control strategy documents, technology transfer change controls, engineering, clinical, and PPQ batch protocols in coordination with R&D.
- Responsible for process stewardship throughout lifecycle management of commercial manufacturing processes.
- Design Process Performance Qualification (PPQ) plans to demonstrate manufacturing process performance.
- Oversee product technical lifecycle management, including process control strategy, process/yield improvement, and regulatory CMC registration detail.
- Support product pre-approval inspections and prepare cGMP documents as needed.
Requirements:
- Bachelor of Science Engineering or a similar technical degree.
- Minimum of 6 years' experience in technical transfer and process validation.
- Experience working in FDA-regulated environments and parenteral facility operations settings.
- Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.
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