Manager Production - Aseptic

Location:

Windsor, CO

Shift: Monday - Friday days with flexibility to support off shifts as required

About Tolmar

Tolmar is an innovative pharmaceutical company focused on developing and manufacturing specialty therapies for patients with unmet medical needs. Headquartered in Northern Colorado, Tolmar combines scientific rigor, operational excellence, and a collaborative culture to make a meaningful impact on patients and communities.

Why Tolmar

At Tolmar, leaders are empowered to make decisions, improve processes, and grow their careers. Our culture is rooted in putting people first, accountability, continuous improvement, and ethical leadership. We foster an environment where transparency, respect, and ownership drive meaningful results.

Why This Role Matters

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.

What You'll Do

• 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.

What Sets This Role Apart

• Opportunity to lead complex operations with high visibility and impact on patient outcomes.
• Strategic influence on process improvement, compliance readiness, and operational performance.
• Hands-on leadership in a collaborative manufacturing environment that values continuous improvement and people development.
• Direct contribution to regulatory excellence and long-term manufacturing capability.

What You Bring

• 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.
• Ability to lead change, support management decisions, and communicate proactively and positively.

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…