Supervisor, Manufacturing

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 110,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, and vision benefits

Competitive PTO and 8 holidays

Tuition reimbursement

Job summary

Catalent Pharma Solutions in Harmans, MD is seeking a Supervisor, Manufacturing to lead upstream production teams and ensure compliant, efficient operations on site. You will oversee process monitoring, media preparation, and harvest while training staff and maintaining quality records.

The role requires strong GMP experience, leadership, and collaboration with QA, MS&T, Engineering, Facilities, and clients to drive campaigns and technology transfers. Onsite day shift.

Qualifications

• Master’s degree in a Scientific, Engineering, or Biotech field with 4–6 years of upstream biologic production under GMP
• Bachelor’s degree in a Scientific, Engineering, or Biotech field with 6–8 years of upstream production under GMP
• High School or Associate with 8–10 years of upstream production under GMP
• Experience in mammalian or microbial cell culture is required
• Solid experience with large-scale centrifuges, washers, and autoclaves
• Demonstrate ability to apply scientific/technical knowledge to solve production challenges
• Maintain GMP documentation including batch records, SOPs, deviations
• Strong communication and teamwork with technical and non-technical stakeholders
• Commitment to continuous learning and process improvement
• Leadership experience at Catalent may substitute external experience

Responsibilities

• Supervise day-to-day manufacturing operations, personnel, and production activities to ensure safe, efficient, and compliant execution.
• Lead, train, coach, and develop teams in GMP requirements, safety standards, and operational excellence.
• Build high-performing, engaged teams through collaboration and accountability.
• Manage employee performance including coaching, reviews, hiring support, onboarding, and retention.
• Ensure batches meet quality, regulatory and GMP requirements including QA closeout.
• Author and maintain manufacturing documentation (SOPs, batch records, logbooks).
• Lead deviation investigations, CAPA activities, and regulatory readiness.
• Partner with QA, MS&T, Engineering, Facilities, Project Management, and clients to execute campaigns and transfers.
• Oversee critical processes, equipment operation, maintenance coordination and validation activities.
• Drive continuous improvement and provide regular production updates.
• Other duties as assigned.

Skills

Leadership

GMP compliance

Team supervision

Process monitoring

Cross-functional collaboration

Quality Assurance

Documentation control

Education

Master’s degree in Science/Engineering/Biotech

Bachelor’s degree in Science/Engineering/Biotech

High School or Associate with extensive experience

Tools

Centrifuges

Washers

Autoclaves

Job description

Job Description

Supervisor, 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 Supervisor, Manufacturing to join our team. In this role, you will lead teams to execute procedures for upstream manufacturing and support areas using standard operating procedures and batch records. You will oversee production equipment operations for upstream processing, including process monitoring, media preparation, and harvesting. You will ensure all team members are fully trained and compliant before entering the production floor, while maintaining high standards of quality and safety.

Shift: Day shift 7pm-7am on a 2-2-3 rotation
Location: Harmans, MD - BWI
100% Onsite

The Role

• Supervise day-to-day manufacturing operations, personnel, and production activities to ensure safe, efficient, and compliant execution.

• Lead, train, coach, and develop teams in GMP requirements, safety standards, and operational excellence.

• Build high-performing, engaged teams by fostering collaboration, accountability, diversity, and continuous development.

• Manage employee performance through coaching, performance reviews, hiring support, onboarding, and talent retention initiatives.

• Ensure production batches meet quality, regulatory, and GMP requirements, including batch review and closeout with Quality Assurance.

• Author, review, and maintain manufacturing documentation, including SOPs, batch records, logbooks, validation protocols, and related records.

• Lead deviation investigations, CAPA activities, and compliance initiatives to drive quality improvements and regulatory readiness.

• Partner with cross-functional groups, including QA, MS&T, Engineering,

• Facilities, Project Management, and clients, to execute production campaigns and technology transfers.

• Oversee critical manufacturing processes, equipment operation, maintenance coordination, validation activities, and accurate scientific data analysis.

• Drive continuous improvement initiatives by identifying process efficiencies, resolving operational challenges, and providing regular production updates to stakeholders.

• Other duties as assigned

The Candidate

Minimum Requirements

• Master’s degree in a Scientific, Engineering, or Biotech field with 4–6 years of experience in upstream biologic production processes under Good Manufacturing Practice compliance OR

• Bachelor’s degree in a Scientific, Engineering, or Biotech field with 6–8 years of experience in upstream biologic production processes under Good Manufacturing Practice compliance OR

• High School Diploma or Associate Degree with 8–10 years of experience in upstream biologic production processes under Good Manufacturing Practice compliance

• Experience in mammalian or microbial cell culture is required

• Solid experience with large-scale centrifuges, washers, and autoclaves

• Apply scientific and technical knowledge to solve routine production challenges, operate equipment effectively, and support manufacturing operations.

• Maintain accurate GMP documentation, including batch records, SOPs, deviations, summary reports, and related manufacturing records.

• Demonstrate strong communication, collaboration, and teamwork skills while working effectively with both technical and non-technical stakeholders.

• Exhibit continuous learning, adaptability, creativity, and multitasking abilities, with a commitment to professional growth and process improvement.

• 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 Good Manufacturing Practice environment, including bioreactor setup and operation, aseptic processing, process monitoring, sampling, troubleshooting, and batch record documentation

Pay

The anticipated salary range for this position in MD is $110,000 – $130,000 Plus Bonus. 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.

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 improving lives

• Competitive paid time off plus 8 paid holidays

• Community engagement and green initiatives

• Medical, dental, and vision benefits effective day one

• 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.

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 [e-mail]. 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.

Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.

Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.