Supervisor, Central Services - Severn Maryland

Company: Disability Solutions
Location: Severn, Maryland
Posted On: 11/20/2024

Supervisor, Central ServicesCatalent Pharma Solutions is looking to hire a Supervisor, Central Services (Night Shift) to support our Gene Therapy Team in Harmans, MD This position will take place on night shift, (7:00pm-7:00am on a 2-3-2 rotation). This role will require a rotating schedule that will include working on Weekends.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--. 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.The Supervisor, Central Services is responsible for supporting the overall cGMP manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk products from microbial and cell culture systems for Phase I/II GMP manufacturing.The Supervisor, Central Services performs production operations including but not limited to preparation of media and buffer solutions as well as being involved in both start-up and product changeover activities, and completing daily manufacturing tasks as well as supporting more in-depth, long term projects.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

• Completes daily manufacturing tasks per standard operating procedures and batch document instructions and monitors critical process parameters.
• During technical transfer and the start-up activities, provide input on design and operation of equipment and effectively troubleshoot equipment and processing problems.
• Lead resolution of technical and process problems, initiate change control for equipment/process modifications.
• Identify, develop and implement process improvements, equipment improvements/upgrades.
• Actively participates in the creation and revision of Batch Records, Standard Operating Procedures and other GMP documents.
• Receive, stage and track materials.
• Ensures all production activities are completed in a safe and compliant manor.
• Communicate assignments, milestones and deadlines to the team and individuals based on supervisor's instructions.
• Monitor and audit work processes to ensure compliance and completion of targets.
• Trains new and less experienced team members.
• Other duties as assignedThe Candidate
  • Bachelor's Degree with 5+ years of directly related experience OR Associates Degree with 7+ years of directly related experience
  • 5+ years prior manufacturing experience in the pharmaceutical or biotechnology industry, with the demonstration of a high level of performance.
  • Proficient and a high level of understanding of the basic FDA cGMP regulations.
  • 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 experience.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.Why you should Join Catalent
    • Defined career path and annual performance review and feedback process
    • 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 ReimbursementCatalent 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 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 . 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 . More...

          

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