Supervisor, Manufacturing

Catalent Pharma Solutions • Glen Burnie, MD

1d • Onsite

About The Position

Supervisor, Manufacturing (Upstream) Position Summary: Work Schedule: 7pm-7am 2-2-3 100% on-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. Catalent Pharma Solutions in Harmans, MD is hiring a Manufacturing Supervisor. The Manufacturing Supervisor is accountable for leading teams to execute manufacturing procedures and support areas of manufacturing using SOP’s and batch records. Operating production equipment for upstream and downstream processing 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 Manufacturing Supervisor will report to the Manufacturing Manager. The Manufacturing Associates on shift will report to the Manufacturing Supervisor. The Role: Supervision of manufacturing processes and personnel and ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines. Drive engagement and 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. 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. Ensure batches adhere to established Quality standards. Execute and monitor critical processes supporting mammalian and microbial production facilities. Provide support to cross-functional teams to meet production or timeline demands. Adhere to Quality standards and learn and comply with regulatory requirements. Complete manufacturing documents such as batch records and logbooks and write standard operating procedures (SOP’s) and other documents as necessary. Ensure the completeness and accuracy of manufacturing documentation per approved procedures. Identify and support the implementation of process efficiencies and areas for improvement and ensure solutions are consistent with organization's objectives. Ability to generate SOPs for equipment and procedures used in the manufacture of biological products. Other duties as assigned. The Candidate:

Requirements

• 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.
• Demonstrable professional leadership experience.
• Experience in mammalian or microbial cell culture is required.
• Solid experience with the following: large-scale centrifuges, washers, and autoclaves.
• Proficient knowledge and ability to apply scientific principles utilized to solve operational, as well as routine production tasks.
• Proficient knowledge of documentation including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports.

Nice To Haves

• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external leadership experience.

Responsibilities

• Supervision of manufacturing processes and personnel and ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines.
• Drive engagement and 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.
• 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.
• Ensure batches adhere to established Quality standards.
• Execute and monitor critical processes supporting mammalian and microbial production facilities.
• Provide support to cross-functional teams to meet production or timeline demands.
• Adhere to Quality standards and learn and comply with regulatory requirements.
• Complete manufacturing documents such as batch records and logbooks and write standard operating procedures (SOP’s) and other documents as necessary.
• Ensure the completeness and accuracy of manufacturing documentation per approved procedures.
• Identify and support the implementation of process efficiencies and areas for improvement and ensure solutions are consistent with organization's objectives.
• Ability to generate SOPs for equipment and procedures used in the manufacture of biological products.
• Other duties as assigned.

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager