Group Lead, Manufacturing

Catalent•Harmans, MD

3d•Onsite

About The Position

Group Lead, Manufacturing About Site Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. Position Summary We have an opportunity for a Group Lead, Manufacturing to join our team. In this role, you will support the execution of clinical and commercial manufacturing in compliance with GMP standards. You will help drive process optimization, efficiency, and continuous improvement to maximize capacity. This position combines hands-on production with leadership responsibilities to ensure safe, compliant, and efficient operations. You will play a key role in guiding the team and supporting the transfer of new projects into GMP production.

Requirements

Bachelor's or Master’s degree in a technical discipline (e.g., biology, biotechnology, engineering) or related life science field with a minimum of 4 years of related experience, OR Associate’s degree with a minimum of 6 years of related experience, OR 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

Nice To Haves

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) may be considered in place of external experience.
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

Responsibilities

Provide day-to-day leadership and work direction for Manufacturing Associates and Technicians, including indirect supervisory responsibilities.
Lead Tier 1 operational meetings and drive performance across safety, quality, delivery, cost, and employee engagement metrics.
Promote operational excellence and continuous improvement initiatives, acting as a change agent to enhance manufacturing efficiency and effectiveness.
Support rapid issue resolution by troubleshooting process and equipment challenges and partnering with Facilities, Validation, and Engineering teams.
Ensure personnel are properly trained and compliant with cGMP requirements, manufacturing procedures, documentation practices, and safety standards.
Complete, review, and revise manufacturing documentation, including Batch Production Records (BPRs), Standard Operating Procedures (SOPs), and related GMP records.
Collaborate with Process Development, Manufacturing Sciences & Technology (MS&T), and Production Management to support technology transfers, new product introductions, and manufacturing projects.
Lead or support deviation investigations, CAPAs, validation activities, facility expansions, and continuous process improvement initiatives.
Serve as a key manufacturing representative for clients, cross-functional teams, and external stakeholders, supporting manufacturing campaigns, project execution, and production readiness.
Perform other duties as assigned.