Sterile Manufacturing Operations Lead
3 weeks ago
Civica Rx, a 501(c)(4) social welfare organization, aims to reduce chronic generic drug shortages and related high prices in the United States. Established in 2018, the organization has supplied essential medicines to the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile.
The Manufacturing Specialist Line Lead will play a critical role in the facility start-up at the Civica Petersburg, VA site. Primary responsibilities will focus on leading daily manufacturing activities on the floor, performing routine equipment, production, and line activities, and the timely production of pharmaceuticals.
The ideal candidate will have a consistent track record of achieving results in a fast-paced, sterile manufacturing environment and maintaining a positive culture. Key qualifications include a minimum of four+ years' experience in biopharmaceutical manufacturing in a GMP environment and experience with sterile fill-finish manufacturing.
Responsibilities will include leading the day-to-day production activities on the line, collaborating with cross-functional teams to meet production needs, and supporting the onboarding and technical training of Manufacturing Operators on process equipment. The Manufacturing Specialist Line Lead will also assist in the revision and management of manufacturing documents, provide technical expertise and support to production teams, and support regulatory inspections.
The estimated salary for this position is between $60,000 and $90,000 per year, depending on experience. The location is Petersburg, VA - 23803. Civica Rx offers a dynamic and challenging work environment, and the opportunity to make a meaningful impact in the healthcare industry.
Key Responsibilities:
- Lead daily manufacturing activities on the floor
- Collaborate with cross-functional teams to meet production needs
- Support the onboarding and technical training of Manufacturing Operators
- Assist in the revision and management of manufacturing documents
- Provide technical expertise and support to production teams
- Support regulatory inspections
Required Qualifications:
- Minimum of four+ years' experience in biopharmaceutical manufacturing in a GMP environment
- Experience with sterile fill-finish manufacturing
- Knowledge of GMP, regulatory requirements, and industry best practices
- Detailed-oriented with a focus on accuracy in creating and updating production documents
Preferred Qualifications:
- 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
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