Manufacturing Specialist Line Lead
2 days ago
Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications.
Job SummaryThe Manufacturing Specialist Line Lead will play a critical role in the facility start-up at our Civica Rx Petersburg, VA site. This position will lead daily manufacturing activities on the floor, perform routine equipment and production activities, and ensure the timely production of pharmaceuticals.
Key Responsibilities- Lead the day-to-day production activities on the line, aligning and scheduling personnel and resources to meet daily and weekly production and equipment demands.
- Collaborate with cross-functional teams, including Manufacturing, Quality Operations, Environmental Health and Safety, to meet production needs.
- Support the onboarding and technical training of Manufacturing Operators on process equipment, including high-speed fill lines with integrated Isolators, Terminal Sterilizers, and Aseptic Process Simulations.
- Assist R&D and MSAT on new product introduction and tech transfer activities to ensure a steady stream of products to meet commercial demand.
- Initiate and complete manufacturing investigations, including root cause analysis and product impact assessment.
- Assist in the revision and management of manufacturing documents, such as Batch Records and SOPs.
- Provide technical expertise and support to production teams, addressing issues and challenges as they arise.
- Support regulatory inspections and adapt to changes in the production schedule due to unforeseen disruptions.
- A minimum of four+ years' experience in biopharmaceutical manufacturing in a GMP environment.
- An associate's degree or higher in Pharmaceutical Sciences, Biology, or a related field is preferred.
- Experience with sterile fill-finish manufacturing and knowledge of GMP, regulatory requirements, and industry best practices.
- Detailed-oriented with a focus on accuracy in creating and updating production documents.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Experience in a process improvement environment, including change management.
- Experience in using ERP systems and strong communication and collaboration skills.
- Experience performing as a shift lead of a team, training others, and developing training material.
- Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).
- Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
- Proficiency in Microsoft Office Suite.
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