We are seeking an experienced Senior Microbiologist to join a team at a leading Biologics Manufacturing site. This individual will provide expert microbiological and analytical support to ensure that all necessary microbiological procedures and requirements are consistently met in this sterile biologic's facility. This facility specializes in the sterile fill-finish of both liquid and lyophilized products in vial formats.
Key Responsibilities:
- Implement the sterility assurance program and microbiological support activities, including facility design, sterile product filling, and aseptic practices.
- Lead microbiological and analytical services to meet and maintain aseptic processing, facility design, and sterile product filling requirements.
- Oversee the environmental monitoring (EM) and utilities programs, aseptic practices, and contamination control strategy within a multi-product facility.
- Provide microbiological/sterility assurance and technical governance for in-process and finished product requirements.
- Ensure compliance with regulations and business processes to meet industry standards, including cGMP, and sterile product requirements, particularly around facility design, cross-contamination controls, microbiological lab standards, and data integrity.
- Develop and update microbiological and environmental monitoring procedures for the site.
- Collaborate with regulatory and corporate inspectors and auditors.
- Deliver training to support the sterility assurance program in line with the training plan.
- Contribute to a culture of EHS excellence by identifying opportunities for improvement.
- Ensure adherence to all environmental health and safety (EHS) policies, procedures, and best practices.
Qualifications:
- Bachelor's degree in Biology or Microbiology.
- Solid understanding of aseptic and sterile processes, with experience in a GMP environment.
- At least 3-5 years of experience in microbiology, in a sterile/aseptic or pharmaceutical environment.
- Experience supporting regulatory inspections is advantageous.
- Cleaning validation knowledge is advantageous.
