Drug Product Manufacturing Group Lead

Responsibilities

• Perform manufacturing tasks in accordance with established SOPs and cGMP regulations
• Oversee non-exempt Drug Product Manufacturing staff, including scheduling and performance management
• Write deviations, OOS reports, and other investigations pertaining to the group
• Review GMP documents and batch records to ensure compliance and inspection readiness
• Troubleshoot mechanical issues with manufacturing equipment and semi-complex processes
• Implement process improvements, training, and new technologies to enhance operations
• Direct manufacturing associates to streamline processes and ensure operational oversight
• Maintain production equipment and manufacturing suites

Requirements

• High School Diploma required; Bachelor's degree in science or engineering preferred
• 5 years of manufacturing or laboratory experience (without a degree) OR 4 years of experience (with a degree)
• Minimum of 1 year of functional or day-to-day leadership experience
• Strong written and verbal communication skills
• Ability to work independently and follow detailed directions in a GMP environment
• Ability to stand for extended periods and lift up to 50 pounds
• Ability to perform duties while donning aseptic gowning

Benefits

• Competitive hourly rate with eligibility for an annual performance bonus
• 10% shift differential for 2nd shift hours
• Paid time off
• Health insurance coverage, including dental and vision
• Flexible spending account
• 401(k) plan

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on quality, operational excellence, and providing an industry-leading experience for our people and customers.