Group Lead, Manufacturing
$89,981–$109,990 year
On-siteHarmans, Maryland, United States
Job Summary
Lead Tier 1 operational meetings and drive performance across safety, quality, delivery, cost, and employee engagement metrics for Manufacturing Associates and Technicians. Provide day-to-day leadership and work direction, ensuring personnel are properly trained and compliant with cGMP requirements, manufacturing procedures, and safety standards. Troubleshoot process and equipment challenges, complete and review manufacturing documentation including Batch Production Records and SOPs, and lead deviation investigations and CAPAs. Collaborate with cross-functional teams to support technology transfers, new product introductions, and facility expansions while promoting operational excellence and continuous improvement initiatives. Work a night shift (7pm-7am) on a 2-2-3 rotating schedule in an FDA-licensed CGMP facility supporting Phase 3 through commercial manufacturing of viral vector therapies.
Required Qualifications
- Bachelor's or Master's degree in a technical discipline (e.g., biology, biotechnology, engineering) or related life science field
- Minimum of 4 years of related experience
- Associate's degree with a minimum of 6 years of related experience
- High School Diploma with a minimum of 7 years of related experience
- Outstanding knowledge and ability to apply scientific principles to solve operational and routine production tasks
- Demonstrated focus on safe behaviors and ability to recognize unsafe conditions
- Thorough understanding of quality systems in a regulated environment and commitment to right first time (RFT) execution
- Excellent documentation skills including comprehension, review, and establishing Batch Production Records, SOPs, deviation, and summary reports
- Proficient knowledge and ability to apply scientific principles to solve operational and routine production tasks
- Team-oriented and able to build strong working relationships across departments
- Actively pursues learning of required skills, new skills, and new equipment
- Proficient understanding of equipment function and application
- Proficient in MS Office and related PC skills
- Ability to work a set shift with flexibility for overtime when required
- Extended amount of time walking, standing, bending, reaching, pushing, and pulling
- 100% Onsite
- Night shift, 7pm-7m on a 2-2-3 rotating schedule
- Location: Harmans, MD - BWI
Desired Qualifications
- Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent‐sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW)
- Experience with bacterial fermentation processes in a GMP manufacturing environment, including bioreactor setup and operation, aseptic processing techniques, process monitoring, sampling, troubleshooting, and batch record documentation
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