Supervisor, Manufacturing
Summary:
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
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 (https://biologics.catalent.com/our-locations/north-america/baltimore-usa/) . 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.
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent's advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.
The Manufacturing Supervisor is accountable for leading teams to execute manufacturing procedures and support area of manufacturing using SOP's and batch records. Operating production equipment for upstream and downstream processing that may include process monitoring, media prep and harvesting. This position is accountable for ensuring all team members are trained and training is completed on time prior to entering the production floor. The Supervisor, Manufacturing will report to the Manager, Manufacturing. The Manufacturing Associates will report to the Supervisor, Manufacturing.
This is a full-time on-site position, 7am-7pm 2-2-3
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.
The Role:
Supervision of manufacturing processes and personnel, ensuring staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
Build effective teams that apply their diverse skills and perspectives to achieve common goals and drive engagement to create a culture where employees are motivated to do their best.
Oversee daily activity for the group to ensure quality results Performance management for direct reports.
Draft and revise official manufacturing documents, SOPs, Batch Records, Validation Protocols.
Lead initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs.
Coordinate with other production supervisors, managers, and project managers to execute production campaigns on-time as well as collaborate with MST and development groups to assist with tech-transfer, scale-up, and translation activities.
GMP batch review and close-out with Quality Assurance group, ensure batches adhere to established Quality standards.
Conduct performance reviews of manufacturing associates and provide input for hiring new manufacturing associates and conduct interviews.
Provide daily production updates to production managers, client representatives, and project managers.
Provide guidance for continuous improvement initiatives with the team.
Represent the department to clients and on cross-functional project teams.
Execute and monitor critical processes supporting mammalian and microbial production facilities- extensive experience with the following: large-scale centrifuges, washers, autoclaves.
Ability to contribute to the development of new concepts, techniques, and standards.
Assist Facilities and Engineering personnel as necessary on equipment maintenance and calibration.
Demonstrate understanding in scientific concepts, technical operations, safety, and Good Manufacturing Practice.
Lead by example, keeping in mind organizational values, policies and goals. Develop people and team coaching and collaboration.
The Candidate:
Masters' degree in a Scientific, Engineering or Biotech field with 4 - 6 years' direct experience with biologic production processes under GMP compliance.
OR
Bachelor's degree in a Scientific, Engineering or Biotech field with 6 - 8 years' direct experience with biologic production processes under GMP compliance.
OR
HS Diploma or Associate Degree with 8 - 10 years' experience with direct experience with biologic production processes under GMP compliance.
Proven professional leadership, with Catalent leadership program participation considered.
Solid experience in mammalian or microbial cell culture and large-scale bioprocessing equipment (centrifuges, washers, autoclaves).
Ability to apply scientific principles to solve production tasks and strong knowledge of GMP documentation (BPRs, SOPs, reports).
Actively seeks new knowledge and skills, possesses strong equipment understanding, excels in team environments, and communicates effectively across diverse audiences.
The anticipated salary range for this position in Maryland is $93,280 to $128,260 plus shift differential and annual bonus, when eligible. The final salary 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.
Position Benefits:
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of paid time off annually + 8 paid holidays
Competitive salary with yearly bonus potential
Community engagement and green initiatives
Generous 401K match and Paid Time Off accrual
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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any @type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .
