Supervisor - Parenteral Operations - Formulation (Days)

Role Summary

Supervisor - Parenteral Operations - Formulation (Days) leads the Parenteral (PAR) manufacturing team during startup and ongoing operations, focusing on product formulation, aseptic isolator barrier filling, and visual inspection. The role develops an inclusive culture, ensures staffing of trained personnel, enforces safety and quality standards, and drives operational readiness at a new Concord, North Carolina site with up to domestic and international travel as needed.

Responsibilities

• Integrity: Lead with a Safety first, Quality Always mindset; promote Stop Work Authority when safety or product quality is at risk; maintain a safe work environment and support HSE goals; act as administrator and technical leader ensuring adherence to procedures and quality systems.
• Excellence: Collaborate with area supervisors to maintain high standards of communication and consistency; manage shop floor execution to meet production goals and cGMP standards; drive continuous improvement and develop training plans; ensure adequate, trained personnel; develop area documentation; investigate deviations and support corrective actions.
• Respect for People: Build a diverse, empowered team; manage direct reports across multiple lines; coach and evaluate operators; communicate with support teams on quality, equipment, and operations issues.

Qualifications

• Required: High School Diploma or equivalent
• Required: Prior supervisory experience
• Required: Basic computer skills (desktop software, MS Office)
• Required: Experience in operations or supporting a manufacturing operation (Pharma, Food, Clean-room, or similar)
• Required: Excellent interpersonal, written, and oral communication skills
• Required: Strong organizational skills and ability to manage multiple priorities
• Required: Strong technical aptitude and ability to train and mentor others
• Preferred: 4+ years in manufacturing/operations with 2+ years in a supervisory role
• Preferred: cGMP standards and FDA guidelines for production
• Preferred: STEM degree or certification
• Preferred: Experience with aseptic filling, single-use assemblies, isolator technology
• Preferred: Experience with automated, semi-automated, and/or manual inspection; highly automated equipment
• Preferred: Manufacturing Execution Systems and SAP or equivalent systems
• Preferred: Continuous improvement methodologies (lean, Six Sigma); root cause analysis and corrective actions
• Preferred: Ability to organize and motivate teams; experience with facility, equipment, and startup processes
• Preferred: Willingness to travel domestically and internationally for training and collaboration

Skills

• Leadership and people development
• Effective cross-functional communication
• Problem-solving and root cause analysis
• Quality systems and cGMP compliance
• Operational readiness and project coordination

Education

• High School Diploma or equivalent