Manager, Sterility Assurance

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.

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:

• 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 Scientific, Engineering or Biotech field with 3 years’  experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities
• Bachelor’s Degree in relevant discipline required with 5 years experience in cGMP production &/or quality experience, with knowledge and understanding of process, documentation requirements and activities
• Minimum 3 years of progressive leadership experience, including performance management and people development.
• Highly experienced in Bio pharmaceutical manufacturing and/or aseptic processing working in a GMP environment.
• Advanced experience in Aseptic Processing
• Excellent communication and technical writing skills

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 401K
• 152 hours PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity 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, b