Manager, Sterility Assurance - Severn Maryland

Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/07/2025

The Manager, Sterility Assurance will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for Gene Therapy Drug Substance and Drug Product Operations. This individual should be able to work independently with little direction to develop and implement policies and procedures and related completed media fill/APS documentation, Environmental Monitoring sample plans, cleanroom qualifications, environmental monitoring excursions, deviations and sterility failures. Review of sterile filter validations, integrity testing and procedures is also required. The individual is expected to interact with Management, QC and QA leadership. Primary responsibility is to maintain sterility assurance of Aseptically manufactured sterile drug products and viral vector products to ensure its meet GMP compliance (EU Annex, 21CFRs, ISO, USP)Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.The role:

• Provide strategic plan and expertise for the development and implementation of the site Sterility Assurance Program.
• Develop, document and manage microbial control strategy for production processes from incoming raw materials through final product release.
• Develop and Lead Sterility Assurance Council
• Author high level investigations, CAPAs, change controls, related to product, process, OOS, and facility contaminations.
• Write, review, and approve GMP documents, examples: protocols, reports, microbial risk assessments, policies, audit observations, aseptic trainings, DE study and sterility assurance/contamination control related GMP documentations.
• Drive continuous improvement initiatives to improve sterility assurance programs and reduce contaminations.
• Provide technical support to new filling lines/equipment (isolator) during design, control, validations, and start-up activities.
• Lead implementation of rapid micro methods/automation - e.g., Bioburden, Sterility to reduce TAT and to enhance batch disposition process.
• Provide oversight and sterility assurance expertise to Operations to assure aseptic processing meets US and international aseptic processing requirements.
• Assesses facility, cleaning/disinfection and quality systems' state of compliance with internal requirements and appropriate regulations and participates in the development of action plans to correct deficiencies and improve quality processes.
• Provides microbiological expertise to support environmental excursions, deviations, CAPAs and complaints related to aseptic processing.The candidate:
  • Masters' degree in a Microbiology, Engineering or Biotech field with 8-10 years' experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities
  • Bachelor's Degree with 10-12 years in relevant discipline required (e.g., operations, Quality, Sterility Assurances, Contamination controls)
  • Highly experienced in Biopharmaceutical, pharmaceutical manufacturing and/or aseptic processing working in a GMP environment.
  • Advanced experience in Aseptic Processing.
  • Ability to succeed in a team-oriented environment under very dynamic conditions.
  • Excellent communication, technical writing, organizational skills and use of Microsoft office products.The anticipated salary range for this position in Maryland is $126,140-$170,660 plus an annual bonus target. 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:
    • Competitive medical benefits and 401K
    • 152 hours PTO + 8 Paid Holidays
    • Dynamic, fast-paced work environment
    • Opportunity to work on Continuous Improvement ProcessesCatalent 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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