Director, Quality Control - Microbiology

Location

Framingham, MA | United States

Job description

Replimune is a fast-paced growing innovative company that is in the process of bringing on-line a new production facility purposefully designed to manufacture our Oncolytic Immunotherapies. This multi-product facility in Framingham contains cGMP manufacturing suites and Quality Control testing laboratories. Working in collaboration with cross functional teams, the Quality Control (QC) Director, QC- Microbiology will be responsible for setting up and maintaining the QC Microbiology and QC Analytical Laboratories at Replimune’s Framingham facility. The Associate Director/Director QC will be responsible for establishing procedures to support environmental monitoring and utilities testing (water, gas and air supplies) as well as running the raw materials laboratory. The Director, QC will be responsible for overseeing the routine and non-routine activities of the QC Laboratories. It is expected that the Director, QC-Microbiology maintains GMP compliance in the QC laboratories.

This position is based in our  Framingham location and typically has a 5-day on-site expectation.

The Director, QC- Microbiology will be responsible for the Quality Control group in support of the Framingham manufacturing facility. The responsibilities of the Director, QC include, but are not limited, to the following:

• Recruitment and leadership of the QC team ensuring appropriate skills are acquired, training is maintained current, individual goals are set and performance evaluations are complete.
• Setting up and maintaining of the QC Microbiology and Analytical laboratories and systems needed to enable testing requirements in support of the facility.
• Establishing and overseeing the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.
• Oversee the environmental monitoring program including aseptic fill finish (Grade A/B) monitoring. Play a leading role in any excursions and assessing the impact.
• Continually develop the environmental monitoring program in line with regulatory requirements and industry guidance. Develop robust procedures to monitor and proactively identify any trends.
• Play a leading role in the development of the contamination control strategy.
• Management and performance of routine QC testing such as bioburden, endotoxin, B&F testing, growth promotion, Gram stain, microbial ID analysis and raw materials testing.
• Management/planning of water sampling and associated water testing (basic chemical analysis to include USP test for heavy metals, nitrates, pH, conductivity, etc.).
• Management/planning of environmental monitoring sampling to coincide with manufacturing activities.
• Trending and reporting of environmental, water and gas test results.
• Oversee day-to-day operation of the QC Microbiology laboratories including sample management, testing schedules, identification and isolation of detected microbes, equipment maintenance and calibration, inventory control and supply orders.
• Establishing and maintaining procedures for QC testing, including w riting/reviewing SOPs, protocols and reports as necessary.
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Oversee routine raw material testing and ensure, raw material processes are complaint and testing is performed in a timely manner.
• Ensure all analytical and microbiological methods are appropriately qualified/validated.
• Ensure the QC group meets set KPIs and develop and monitor a program of continuous improvement.
• Play a leading role in regulatory inspections and the preparation for regulatory inspections.

Other responsibilities:

• Represent QC at inter-departmental meetings and interact with external vendors as necessary.
• Develop and maintain a culture of continuous improvement within the QC department.
• Ensure completion of change control and deviations related to QC Microbiology operations including assisting with laboratory and OOS investigations.
• Author QC regulatory documentation and assist in regulatory audits/inspections, as needed.
• Troubleshooting of equipment and QC methods.
• Manage / perform assay qualification, as necessary.
• Manage Microbiology related technical studies performed with external companies and review of reports.

Educational requirements:

• BA or BS in Chemistry/Biochemistry/Microbiology or other related science.

Experience and skill requirements:

• Minimum 10+ years GLP/GMP laboratory-based experience in a Microbiology testing capacity and at least 5 years of management experience in a GMP-regulated environment .

• Good analytical skills and technical experience is a must, preferentially with previous experience setting up a testing laboratory and/or supporting a manufacturing facility.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others
• Effective communication skills
• Good organizational skills

Location:  

• This position is based in our  Framingham location and typically has a 5-day on-site expection

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