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Manufacturing Manager
2 months 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 affordable, high-quality medications.
Job DescriptionThe Manager, Manufacturing, Nested Fill will play a critical role in the facility start-up at our Civica Rx Petersburg, VA site. This position will support daily manufacturing operations and the timely production of pharmaceuticals. The successful candidate will develop and support the Manufacturing team by participating in equipment qualifications, identifying and implementing process improvements, and leading the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products.
Key Responsibilities- Participate in new equipment and process qualifications under the Director of Manufacturing's direction.
- Develop and create standard operating procedures, specifications, and governing documents to delineate manufacturing process requirements.
- Ensure the Manufacturing organization operates to meet approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
- Identify opportunities to improve customer service, quality, safety performance, scrap minimization, or reduce manufacturing costs using effective project management, cost control techniques, and Lean Manufacturing.
- Mentor, coach, and teach Manufacturing Associates in statistical tools, Lean/Six Sigma methodologies, and change management/control techniques.
- Utilize scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing.
- Bachelor's degree with 8+ years of demonstrated ability in a cGMP production environment. An Associate degree and 10 years of cGMP production experience may be considered.
- Experience in a sterile fill-finish facility. 3+ years' supervisory experience in a GMP manufacturing environment.
- Strong writing and documentation skills.
- Strong interpersonal, collaboration, communication, and leadership skills.
- Experience in a process improvement environment, including change management, optimizing process flow, and participating in Lean/Six Sigma project teams.
