Aseptic Production Manager

Role Overview

The Production Manager is a key leadership position responsible for ensuring the safe, compliant, and efficient manufacturing of sterile pharmaceutical products. This role has a direct impact on patient safety, regulatory adherence, and operational success by leading aseptic manufacturing operations that consistently meet quality, cost, and delivery targets.

Key Responsibilities

• Lead, mentor, and develop production teams, including direct supervision of front-line supervisors, to drive high performance and achieve operational goals.
• Oversee daily manufacturing activities within aseptic and Grade C environments, ensuring full compliance with cGMP and global regulatory standards (FDA, EMA, etc.).
• Enforce adherence to standard operating procedures (SOPs), process controls, cleanroom protocols, and contamination prevention practices.
• Collaborate cross-functionally with Quality, Engineering, Supply Chain, and Planning to support efficient and compliant manufacturing operations.
• Establish, track, and improve key performance indicators (KPIs), including OEE, process efficiency, changeover time, cost performance, and product quality.
• Lead continuous improvement initiatives and support the implementation of lean manufacturing principles and automation solutions.
• Ensure audit and inspection readiness; act as a subject matter expert during internal audits, regulatory inspections, and compliance reviews.
• Manage investigations, deviations, and corrective/preventive actions (CAPA) for non-conforming events.
• Review and approve operational documentation, including batch records, deviations, change controls, SOPs, inventory transactions, and purchase requests.
• Manage production scheduling, capacity planning, and resource allocation to align with business demands.
• Provide technical expertise and troubleshooting support for manufacturing processes.
• Participate in and lead operational meetings, including Tier Board discussions.
• Promote a culture of safety, accountability, open communication, and respect within the production organization.
• Conduct performance evaluations, support hiring decisions, and ensure consistent leadership practices across teams.

What Makes This Role Unique

• Opportunity to lead high-impact manufacturing operations directly tied to patient outcomes.
• Significant influence on operational excellence, compliance readiness, and process improvements.
• Hands-on leadership role within a collaborative and continuous improvement-focused environment.
• Direct involvement in maintaining regulatory excellence and advancing manufacturing capabilities.

Qualifications and Skills

• Strong knowledge of cGMP regulations related to pharmaceutical manufacturing.
• Demonstrated leadership experience managing supervisors and production teams.
• Excellent analytical, problem-solving, and decision-making skills in fast-paced environments.
• Strong communication skills, both written and verbal, including technical documentation review.
• Deep expertise in aseptic processing, sterile filling, cleanroom operations, and contamination control.
• Proficiency in Microsoft Office (Excel, Word, Outlook).
• Exceptional attention to detail and commitment to documentation accuracy and data integrity.
• Proven ability to lead change, support organizational decisions, and communicate effectively.

Education & Experience

• Bachelor's degree in a scientific or related discipline preferred, or equivalent experience.
• Minimum of 5 years of pharmaceutical manufacturing experience, including at least 3 years in a production leadership role.
• Experience in aseptic or sterile manufacturing environments strongly preferred.

Additional Requirements

• Ability to work shifts in a manufacturing and warehouse environment.
• Flexibility to work evenings and weekends as needed.