The Lead, Sterility Assurance will support the implementation and maintenance of highly performant Sterility Assurance Practices, Procedures and Systems on the Catalent MD sites. This position will lead the following areas: Aseptic processing in clean rooms, cleaning and disinfection process, environmental controls, and drug products compliance to regulations and standard in the subject of sterility assurance and contamination control. Review of sterile filter validations, integrity testing and procedures is also required. The individual is expected to interact with a cross functional team including validation, MS&T, QA, Facilities and QC. The primary responsibility is to maintain sterility assurance of aseptically manufactured sterile drug products and viral vector products to ensure meets GMP compliance standards (EU Annex, 21CFRs, ISO, USP)

Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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:

Lead all aspects of aseptic filling operations, ensuring the sterility of product environments, implementing contamination control strategies, and maintaining operational excellence in isolators ensuring compliance with regulatory and quality standards (FDA, EU GMP).Execution of the site’s Sterility Assurance Strategy and Practices in collaboration with other Business Stakeholders, including in the following areas: Facility Design, HEPA filter certification, Facility Cleaning and Disinfection Program, Aseptic Gowning qualifications and dis-qualifications, Aseptic practices techniques/behaviors, including training of staff, Environmental Monitoring (viable and non-viable) and Contamination, particulates, endotoxin Controls.Utilize microbiological knowledge to develop contamination control strategies, interpret/support microbiological results from media fills, environmental monitoring, and sterility testing.Identify opportunities for process improvement in aseptic techniques, isolator efficiency, and overall contamination control strategies.Implement best practices and corrective actions; perform risk assessments related to aseptic processing, and microbial contamination. Develop mitigation strategies for potential sterility risks.Regularly GEMBA the aseptic practices and environmental monitoring practices on the shop floor to ensure adherence to implemented standard practices, processes and systems by all sites.

The candidate:

Masters’ degree in a Microbiology, Engineering or Biotech field with 3-5 years’ experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activitiesBachelor’s Degree in a Microbiology, Engineering or Biotech field with 5-7 years in relevant discipline required (e.g., cGMP Aseptic operations, Quality, Sterility Assurances, Contamination controls)Highly experienced in Biopharmaceutical, pharmaceutical manufacturing and/or aseptic processing working in a GMP environment.Demonstrate strong scientific understanding of DP Sterility Assurance and ability to investigate contamination events.Advanced experience in Aseptic Processing.

The anticipated salary range for this position in Maryland is $118,720-$163,240 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 401K152 hours PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity to work on Continuous Improvement Processes

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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