Position Summary
We are looking for a Manufacturing Manager who will be responsible in developing and leading the Manufacturing team by participating in equipment qualifications, identifying and implementing process improvements through process monitoring, conducting investigations, and impact assessments according to qualification, compliance, and business requirements.
Duties & Responsibilities
- Lead the Prep and Fill Operations team to execute daily and weekly production schedules to meet operations objectives.
- 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.
- Conduct training and ensure staff training is documented, current, and follows cGMP requirements.
- Assist in the revision, and management of manufacturing documents such as Batch Records and SOPs.
- Identify and address any potential quality issues.
- 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.
- Assist R&D and MSAT on new product introduction and tech transfer activities to meet commercial demand.
Required Qualifications
- 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.
- Experience in a process improvement environment including change management, optimizing process flow, and participating in Lean/Six Sigma project teams.
- Interact with other functions and must be able to take ownership of and follow through on assigned projects.