Manager, Sterility Assurance

Full-time - Manager

Harmans, MD

Chemical Manufacturing

About the position

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).

Responsibilities

• 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.
• Assess facility, cleaning/disinfection and quality systems' state of compliance with internal requirements and appropriate regulations and participate in the development of action plans to correct deficiencies and improve quality processes.
• Provide microbiological expertise to support environmental excursions, deviations, CAPAs and complaints related to aseptic processing.

Requirements

• 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.

Benefits

• Competitive medical benefits and 401K.
• 152 hours PTO + 8 Paid Holidays.
• Dynamic, fast-paced work environment.
• Opportunity to work on Continuous Improvement Processes.