The Manager, Manufacturing, Vial Fill will play a part in the facility start-up with primary responsibilities focused on supporting daily manufacturing operations and the timely production of pharmaceuticals at the VA site. The Manager will develop and support the Manufacturing team by participating in equipment qualifications, identifying and implementing process improvements through process monitoring, conducting investigations, and impact assessments. Lead the manufacturing team to achieve efficient, cost-effective, safe, and compliant production of quality injectable products according to the Client's culture and vision of what is in the best interest of the patient.
Essential Duties and Responsibilities:
- Under the Director of Manufacturing's direction, actively participate in new equipment and process qualifications.
- Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements.
- Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
- Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization, or otherwise reduce manufacturing costs by using effective project management, cost control techniques, and Lean Manufacturing.
- Mentors, coaches, and teaches Manufacturing Associates in the use of statistical tools, Lean/Six Sigma methodologies, and change management/control techniques to ensure timely completion of projects at the expected results.
- Utilizes 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.
- Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis.
- Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, and packaging.
- Flex schedule to meet commitments and achieve milestones related to projects, production, and other demands of the role.
Minimum Qualifications (Knowledge, Skills, and Abilities)
- Bachelor's degree with 8+ years of demonstrated ability in a cGMP FDA, cGMP, ISO, or other regulated production environments. Equivalent education and experience may be considered.
- Advanced experience in a process improvement environment, including project management, change management, and leading Lean/Six Sigma project teams. Certification is a plus.
- Prior high-speed fill/finish (vial, cartridge, PFS, etc.) experience required.
- Expert facilitation skills with demonstrated results.
- Demonstrated excellence in oral and written communication.
- Self-directed with effective analytical and problem-solving skills.