Manager Production - Aseptic

About the role

The Manager Production plays a critical leadership role in ensuring the safe, compliant, and efficient manufacture of sterile pharmaceutical products. This position directly impacts patient safety, regulatory compliance, and business performance by leading aseptic operations that consistently meet quality, cost, and delivery expectations.

Responsibilities

• Lead, manage, and develop production teams, including direct supervision of supervisors, to achieve high performance and departmental objectives.
• Oversee daily manufacturing operations (in both an aseptic and Grade C environments), ensuring full compliance with cGMP, FDA, EMA, and other global regulatory requirements.
• Maintain strict adherence to SOPs, processing standards, cleanroom behavior, and contamination control practices.
• Partner cross-functionally with Quality Assurance, Engineering, Supply Chain, and Planning to ensure efficient, compliant production execution.
• Establish, monitor, and improve KPIs related to OEE, process efficiency, changeover times, cost performance, and quality.
• Drive continuous improvement initiatives, lean manufacturing practices, and support engineering with automation opportunities to enhance operational excellence.
• Ensure audit and inspection readiness, lead responses and serve as the manufacturing SME during internal audits, regulatory inspections, deviations, and compliance findings.
• Coordinate investigations, deviation management, and CAPA implementation for non-conforming events.
• Review and approve batch records, change controls, deviations, work instructions/SOPs, inventory actions, and purchase requisitions impacting operations.
• Manage production scheduling priorities, capacity planning, and resource allocation in alignment with business needs.
• Provide technical support and troubleshooting expertise for the manufacturing processes.
• Actively conduct and participate in Tier Board and manufacturing department meetings.
• Foster an environment of open communication, safety, accountability, and respect across manufacturing teams.
• Perform performance evaluations, support hiring decisions, and ensure consistent leadership practices across the organization.
• Demonstrate integrity, reliability, and proactive leadership while modeling Tolmar’s core values.

Qualifications

• Strong working knowledge of cGMP regulations related to pharmaceutical manufacturing.
• Proven leadership capability with experience managing supervisors and frontline manufacturing teams.
• Strong analytical, problem-solving, and decision-making skills within time-sensitive environments.
• Excellent written and verbal communication skills, including technical writing and document review.
• Deep expertise in aseptic processing, sterile filling operations, cleanroom environments, and contamination control strategies.
• Proficiency in Microsoft Office (Excel, Word, Outlook).
• High attention to detail, strong documentation practices, and commitment to data integrity.
• Able to lead change, support management decisions, and communicate proactively and positively.

Skills

• Strong leadership and team management skills.
• Effective communication and collaboration abilities.
• Compliance with cGMP regulations and regulatory requirements.
• Experience in aseptic and sterile production.
• Technical proficiency in Microsoft Office.
• Attention to detail and strong documentation practices.

Benefits

Tolmar offers a competitive benefits package including:

• Annual pay range: $125,000 - $130,000
• Bonus eligibility
• Employee benefits details available at this link

Pay

The final compensation offered may vary from the posted range based on the selected candidate's qualifications and experience.

Schedule

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

Additional Requirements

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

Core Values

This position is expected to operate within the framework of Tolmar’s Core Values:

• Center on People: Support the well-being of our patients and treat employees and those we serve as valued partners.
• Are Proactive & Agile: Embody a culture of engagement and action with a hands-on approach to adapt to change.
• Act Ethically: Conduct business in an ethical, compliant, and socially aware manner, and cultivate diversity, equity, inclusion & sustainability in the workplace.
• Constantly Improve: Collaborate and proactively improve products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality.
• Are Accountable: Think, act, and communicate with honesty, transparency, and clarity in alignment with core values and take accountability & ownership of work, actions, successes, and setbacks.