Overview:
The Production Manager is accountable for the operational performance—including safety, quality, and delivery—within the Operations department. This role involves providing leadership, setting strategic direction, and coordinating personnel and resources to meet monthly schedules within a cGMP-compliant environment.
Key Responsibilities:
- Production Scheduling: Design and maintain the Production Schedule in collaboration with the Director of Operations.
- Process Transfer: Offer critical input to the process R&D team to ensure successful project transitions from lab scale.
- Root Cause Analysis: Lead and facilitate root cause analysis investigations to identify corrective actions for process deviations.
- Manufacturing Oversight: Supervise manufacturing and cleaning operations, ensuring they comply with cGMP standards and all safety requirements.
- Process Definition: Collaborate with R&D, Quality, and HSE departments to define process-critical parameters and safety aspects affected by scale (e.g., time, operative conditions, equipment properties).
- Budget Participation: Contribute to the preparation of annual budgets, including proposing new investments with sound rationale.
- Documentation: Draft Master Batch Records and review executed Batch Records for approval; draft and review campaign reports.
- SOP Management: Write and approve Standard Operating Procedures (SOPs) in collaboration with other departments.
- Training: Coordinate and conduct training for Operators on batch records prior to manufacturing processes, in collaboration with R&D, HSE, and Quality departments.
- Waste Management: Oversee waste management in coordination with external vendors and HSE.
- Safety Assessments: Conduct risk assessments to identify, analyze, and mitigate potential safety hazards during operations.
- Equipment Compliance: Ensure that all manufacturing/operations equipment complies with cGMP regulations where applicable.
- Technical Support: Provide technical input for the qualification of manufacturing/operations equipment in line with regulatory requirements.
- Regulatory Audits: Assist in the preparation for and interaction with various regulatory agency audits (e.g., FDA, DEA, OSHA), as well as corporate and in-house QA audits, ensuring regulatory documentation remains current.
- Regulatory Compliance: Perform duties in accordance with all state and federal regulations and guidelines, including FDA, EPA, OSHA, and DEA, as well as company and site policies.
- Safety and Quality Responsibility: Assume responsibility for the safety, environmental, quality, and business impacts of all work performed.
- Training Compliance: Successfully complete all regulatory and job-specific training requirements.
Qualifications
• Bachelor’s Degree Chemistry, Chemical Engineering or related field OR an equivalent
combination of education and work experience.
• Minimum 10 years.
• Progressively responsible work experience in a high-volume, multi-product manufacturing
environment
• Significant experience leading and implementing lean manufacturing/Six Sigma initiatives.
• Solid knowledge of GMP and ISO regulations.
• Significant experience in identifying and driving operational change and excellence.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and
constructive feedback respectfully to build positive relationships and improve business
results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at
multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in a timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to occasionally travel domestically and/or internationally.
