Sr Manager Production - Aseptic

Purpose and Scope

The Senior 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 & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• Bachelor's degree in scientific discipline or related field or equivalent experience strongly preferred.
• Seven or more years of experience in pharmaceutical manufacturing, with at least 5 years in aseptic/sterile production leadership roles.

Additional Requirements

• Shift work in a manufacturing and warehouse environment.
• May require weekend and evening work

Compensation and Benefits

• Annual pay range $155,000 - $170,000
• Bonus eligible
• Benefits information: https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.