Description Core Hours Monday - Friday, 8:00 am - 5:00 pm Purpose and Scope The Manager Production - Aseptic is responsible for leading and overseeing aseptic manufacturing operations within the pharmaceutical facility. This role ensures consistent compliance with cGMP, regulatory standards, and company quality objectives while driving operational excellence, efficiency, and safety. The Senior Manager will provide strategic direction, people leadership, and technical expertise to ensure high-quality, timely, and cost-effective production of sterile drug products. Key Responsibilities Lead, manage, and develop aseptic production teams to achieve departmental goals and ensure high performance. Oversee daily aseptic manufacturing operations, ensuring compliance with FDA, EMA, and other global regulatory requirements. Maintain strict adherence to cGMP, SOPs, and aseptic processing standards. Partner with Quality Assurance, Engineering, and Supply Chain to ensure smooth and compliant production processes. Monitor and improve manufacturing performance through KPIs, root cause analysis, and continuous improvement initiatives. Ensure readiness for internal and external audits; lead responses to regulatory inspections and compliance findings. Drive operational excellence by identifying and implementing process improvements, automation opportunities, and lean manufacturing practices. Collaborate with the planning and scheduling teams to manage production scheduling, capacity planning, and resource allocation to meet business needs. Provide technical support and guidance on aseptic techniques, cleanroom behavior, contamination control, and process troubleshooting. Actively conduct and attend Tier Board meetings at all levels. Actively supervise and manage the performance of supervisors in the aseptic manufacturing group. Prepare and track KPIs related to OEE, process efficiencies and changeover times. Actively track and problem solve, if necessary, batch rejections based on product cost analysis. Manage the performance of operators when situations require additional management support. Conduct interviews and make hiring decisions on supervisory employees, and provide oversight on employment decisions. Interact with peers and members of other departments in team settings in a professional manner. Ensure open and transparent communication to manufacturing employees about company priorities, policies and general company announcements. Provide guidance to supervisory employees for the delivery of information. Conduct employee performance evaluations. Communicate and set daily production priorities with supervisors and manufacturing employees. Create, revise and implement Standard Operating Procedures (SOPs) and Production Batch Records. Assist with Batch Record review, as necessary, including prioritization, reviewing corrections, and following up to ensure timely completion. Ensure timely and accurate postings of all Manufacturing Orders (MOs) for month end closing. Review and take action related to monthly overhead variance report to ensure accuracy of inventory. Coordinate the completion of investigations and CAPA implementations for non-conforming events. Pre-approve expiration dates on batch records prior to manufacturing. Perform functional area management review and approval of deviations and associated CAPA actions. Complete and approve change assessments for Change Controls impacting aseptic operations area. Review and approve Inventory and Purchase Requisitions in accordance with company procedures. Identify missing items for pending manufacturing processes. Attend manufacturing department meetings. Foster a culture of safety, compliance, accountability, and continuous improvement. Demonstrate a high degree of honesty, initiative, integrity, drive, reliability and trustworthiness. Actively model and foster a positive, respectful, and harassment-free work environment for all employees. Perform other related duties as assigned. Special Skills and Knowledge Mastered knowledge of current Good Manufacturing Procedures (cGMP) as they relate to production packaging activities. Deep knowledge of aseptic processing, sterile filling, cleanroom operations, and contamination control strategies. Proficient in Microsoft Office (Excel, Word, Outlook). Excellent verbal and written communication skills. Ability to adhere to written production records and validation protocols. Strong understanding of basic math and writing skills to document production activities in batch records and/or log books. Excellent attention to detail for documentation in production documents and to compare produced goods against specified requirements. Strong analytical and problem solving skills. Strong technical writing and review skills. Process improvement and Lean transformation experience. Ability to support management's decisions and communicate change positively. Ability to analyze and make decisions within time and schedule constraints. Ability to quickly make decisions and understand the impact on processes and employees. Ability to lead by example and have a proven record of excellence in attendance, dependability and safety. Core Values This position is expected to operate within the framework of Tolmar's Core Values: Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together. Are Proactive
Read Less
