Pharmaceutical Manufacturing Manager

Responsibilities

• Lead a team of manufacturing supervisors to compliantly meet the production schedule in controlled environments
• Interview, hire, coach, and develop staff while providing timely performance feedback
• Partner with quality and technical services leaders to author, review, and approve investigations
• Approve SOPs, validations, and protocols in a timely manner
• Support client projects and client audits
• Manage organizational budget and maintain expenses within the plan
• Foster a culture of safety and adhere to all environmental, health, and safety SOPs
• Implement lean manufacturing principles and a "go and see" culture

Requirements

• Bachelor’s degree in a scientific or engineering discipline preferred
• Minimum 5 years of experience in aseptic pharmaceutical manufacturing
• Minimum 3 years in a leadership role, preferably in parenteral manufacturing
• Strong knowledge of GMPs and worldwide regulatory agency guidelines
• Experience with Lean Manufacturing (value stream mapping, kaizen events)
• Proficiency in Microsoft Office and enterprise software (e.g., JDE, Trackwise)
• Ability to gown qualify for Grade A/B clean room areas
• Ability to stand for extended periods and wear respirators if required

About the Company

Simtra BioPharma Solutions is a world-class Contract Development Manufacturing Organization (CDMO) partnering with pharmaceutical and biotech companies to bring sterile injectable products to market, including biologics, small molecules, and vaccines.