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.
Shift: Night shift, 7pm-7m on a 2-2-3 rotating schedule
Location: Harmans, MD - BWI
100% Onsite
The Role
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.
The Candidate
Minimum 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
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.
Preferred Skills & Background
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
Pay
The anticipated hourly rate for this position in MD is $43.26 - $52.88 Plus Bonus. The final hourly rate offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the @type and length of experience within the job, @type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.
Why You Should Join Catalent
Defined career path with annual performance reviews and feedback
Diverse and inclusive culture
Opportunities for career growth within an organization dedicated to preserving and improving lives
Competitive paid time off plus 8 paid holidays
Community engagement and green initiatives
Medical, dental, and vision benefits effective day one of employment
Tuition reimbursement
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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