Supervisor, Manufacturing

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:

• 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.
• 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.
• 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.

Why you should join Catalent:

• 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!

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 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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