Onsite GMP Central Services Manager - Biotech Manufacturing

Catalent; Harmans (MD); On-site; USD 135,000 - 165,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Tuition Reimbursement

Paid time off & holidays

Job summary

Catalent is seeking a capable Manager, Central Services to lead GMP manufacturing operations for buffer and media preparation at our Harmans, MD site. You will plan production, oversee start-ups and changeovers, and drive efficiency and compliance while guiding a team of professionals.

The role requires strong leadership, cGMP expertise, and commitment to safety, with collaboration across internal teams to ensure batch success and continuous improvement.

Qualifications

• Bachelor’s Degree with 8+ years of related experience or Associate’s Degree with 10+ years of related experience.
• 6+ years manufacturing experience in the pharmaceutical/biotech industry.
• Proficient understanding of FDA cGMP regulations.
• 4 years of direct or progressive people leadership experience.
• Strong scientific/technical expertise with equipment knowledge.
• Committed to safety and compliant operations.
• Quality systems knowledge, right-first-time focus.
• Excellent documentation and computer skills (SOPs, deviations, reports).
• Catalent leadership program experience may substitute external experience.

Responsibilities

• Manage buffer and media weigh/dispense/production suites, clean/sterile assembly prep, and material sampling.
• Drive design, acquisition, and implementation of new buffer/media prep technologies.
• Assist with transfer of new buffers/media formulations with GMP Operations and Development labs.
• Supervise cGMP suite cleaning, waste removal, stocking, and material movement within suites.
• Supervise production staff training and hands-on operation for various batches.
• Coordinate change-over activities; own maintenance, calibration, and validation of equipment/suites.
• Prepare/revise master batch records, SOPs, deviations, and close-out cGMP documents.
• Troubleshoot equipment issues and deviations; report and resolve deviations and change controls.

Skills

Leadership

cGMP knowledge

FDA regulations

Cross-functional collaboration

Documentation

Safety orientation

Problem solving

People leadership

Shift adaptability

Education

Bachelor’s Degree

Associate’s Degree

Tools

Microsoft Office

Job description

Catalent is seeking a capable Manager, Central Services to lead GMP manufacturing operations for buffer and media preparation at our Harmans, MD site. You will plan production, oversee start-ups and changeovers, and drive efficiency and compliance while guiding a team of professionals.

The role requires strong leadership, cGMP expertise, and commitment to safety, with collaboration across internal teams to ensure batch success and continuous improvement.