QC Manager Microbiology – Framingham, MA
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) Manager for Microbiology will be responsible for setting up and maintaining the QC Microbiology Laboratories at Replimune’s Framingham facility. The QC Manager will be responsible for establishing procedures to support environmental monitoring and utilities testing (water, gas and air supplies). The QC Manager will be responsible for overseeing the routine and non-routine activities of the QC Microbiology Laboratories. It is expected that the QC Manager maintains GMP compliance in the QC Microbiology laboratory.
This position is based at the Replimune Framingham facility.
The QC Manager for Microbiology will be responsible for the Quality Control Microbiology group in support of the Framingham manufacturing facility. The responsibilities of the QC Manager include, but are not limited, to the following:
- Recruitment and leadership of the QC Microbiology 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 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.
- Management and performance of routine QC testing such as bioburden, endotoxin, B&F testing, growth promotion, Gram stain, and microbial ID analysis.
- 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 writing/reviewing SOPs, protocols and reports as necessary.
- Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
- 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.
Experience and Skill Requirements:
- Minimum 7 years GLP/GMP laboratory-based experience in a Microbiology testing capacity and at least 3 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
- BA or BS in Chemistry/Biochemistry or other related science.
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.