The Senior Manager Microbiology & Contamination Control, will be accountable for the Microbiology QC testing and Contamination Control program at all BioLife facilities. This role will report into the BioLife Director of Quality & liaise closely with Engineering & Operations on Facility design and controls required to mitigate contamination risk. Ability to problem solve and coach others on Microbiology & Contamination control risks and mitigations is essential.
Must have expert understanding and working knowledge with Microbiology & Sterility Assurance standards Quality Control principles and concepts such Microbial Assays, Immunoassays, Analytical assays, water systems, EM programs, etc.
Must have thorough understanding of Good Documentation Practices (GDP), identification and review and approval of deviation investigations and Out of Specifications (OOS) results, able to perform root cause analysis and generate corrective actions to improve processes/systems.
Responsibilities:- Maintain compliance to facility ISO QMS requirements including but not limited to Internal and External Auditing, Nonconforming Materials, CAPA, Method Validation.
- Lead BioLife facility Contamination Control programs in collaboration with Engineering.
- Must be proficient in understanding of Good Documentation Practices (GDP), identification and review and approval of deviation investigations and Out of Specifications (OOS) results, Non-conforming Materials (NCM) to be able to perform root cause analysis and generate corrective actions to improve processes/systems
- Manage the Environmental Monitoring Program and RODI water testing Program.
- Tracking and trending of QC data, directing appropriate corrective actions, as necessary.
- Responsible for Microbiology QC owned Corrective Actions.
- Recommends improvements to methods and assay performance.
- Maximizing productivity.
- Ensures microbiology & contamination control procedures are in place & maintained.
- Reviews and or approves validations related to assays, instruments, processes, environment, and utilities.
- Responsible for team development & performance management
Education and/or Work Experience Requirements:- BS/BA in Microbiology or other related science degree.
- Minimum 10-13 years' related Quality Control experience required.
- Minimum 6-8 years of experience mentoring and supervising direct reports.
- Expertise with microbiology techniques such as aseptic handling of materials and working within a BioSafety Cabinet
- Strong understanding of ISO 9001 & ISO 13485 requirements is required.
- Proficient in managing a department and mentoring direct reports
- Ability to identify continuous improvement to maximize productivity
- Excellent cross-functional team participation and presentation skills.
- Highly organized and detail oriented.
- Lead/Internal auditor certification preferred.
The US base salary range for this position at full-time is $142,000-$206,000 per year.
Typically, new hires are brought in at or near the midpoint of the range to allow for future growth and advancement within the role. This range represents the full compensation range for this position, with consideration given to experience, skills, and qualifications. Our salary ranges are determined by position, level, location, and market competitive benchmarks. Individual pay within a level is determined by work location (including geographic pay zone region), job related skills, experience, education, and training.
The BioLife Solutions (now part of Repligen) total rewards program includes, but is not limited to medical, dental, vision, 401K with generous match, life and disability insurance as well as time off programs of Vacation and Sick time. Additionally, we believe in our team members sharing the success of our business and therefore we may provide cash bonus or stock equity grants based on company performance and department goals as a part of our total rewards package.
