Senior Quality Control Analyst

Replimune; Framingham (MA); Hybrid; USD 93,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k match

Flexible time off

Paid holidays incl. year-end shutdown

Job summary

Replimune, located in Framingham, MA, is seeking a Senior QC Microbiology Analyst to lead setup and routine testing in the new QC Microbiology Laboratory. The role ensures GMP-compliant operations, environmental monitoring, and data review for bioburden, endotoxin, growth promotion, Gram stain, and species identifications.

The ideal candidate has 3–5 years of microbiology lab experience, strong technical microbiology skills, and proficiency with MS Word/Excel.

Qualifications

• Three to five years of Microbiology laboratory-based experience in a QC testing capacity.
• Excellent microbiological skills and technical experience is a must.
• Thorough understanding of industry testing requirements for QC Microbiology and experience of cGMP.
• Computer literacy (MS Word and Excel), good communication and organizational skills.
• Ability to work well independently and with others in a team.

Responsibilities

• Set up and maintain the QC microbiology laboratories and systems needed to enable testing requirements in support of the facility.
• Assist in scheduling and oversight of environmental monitoring testing performed in QC Microbiology laboratories.
• Execute the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.
• Perform routine QC Microbiology sampling and testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications.
• Perform water sampling and associated water testing (such as chemical analysis to include visual appearance, heavy metals, nitrates, pH, conductivity, etc.).
• Sampling and testing of gas supplies to manufacturing suites.
• Trend environmental monitoring data and compile trend reports.
• Write and revise SOPs, protocols and technical reports as necessary.
• Coordinate shipment of samples to contract testing laboratories and review of testing data reports.
• Review testing data of other QC Analysts, as applicable.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory and ordering of supplies, etc.
• Maintain QC Microbiology related systems in compliance with industry standards.

Skills

Microbiology experience

cGMP knowledge

Independent worker

Team collaboration

Communication skills

Education

BA/BS in Microbiology

Tools

MS Word

MS Excel

Job description

Overview

Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it.

At Replimune, we live by our values:

United: We Collaborate for a Common Goal.

Audacious: We Are Bold.

Dedicated: We Give Our Full Commitment.

Candid: We Are Honest With Each Other.

People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.

Join us, as we reshape the future.

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. The Senior Quality Control (QC) Microbiology Analyst will be responsible for the performance of the routine QC sampling and testing within the function of the Quality Control (QC) Microbiology Laboratory. Additionally, the Senior QC Microbiology Analyst will assist in setting up and maintaining the QC Microbiology laboratories, scheduling the routine QC Microbiology testing and oversee the performance of non-routine / investigational testing performed within the Microbiology Laboratories. It is expected that the Senior QC Microbiology Analyst maintains GMP compliance in the QC Microbiology laboratory. This position is based at the Replimune Framingham facility.

Key Responsibilities:

The responsibilities of the Senior QC Microbiology Analyst include, but are not limited, to the following:

• Setting up and maintaining of the QC microbiology laboratories and systems needed to enable testing requirements in support of the facility.
• Assist in scheduling and oversight of environmental monitoring testing performed in QC Microbiology laboratories.
• Execute the environmental, water and gas monitoring program, including environmental qualification of the clean room suites.
• Perform routine QC Microbiology sampling and testing such as bioburden, endotoxin, growth promotion, Gram stain, and microbial identifications.
• Perform water sampling and associated water testing (such as chemical analysis to include visual appearance, heavy metals, nitrates, pH, conductivity, etc.).
• Sampling and testing of gas supplies to manufacturing suites.
• Trend environmental monitoring data and compile trend reports.
• Write and revise SOPs, protocols and technical reports as necessary.
• Coordinate shipment of samples to contract testing laboratories and review of testing data reports.
• Review testing data of other QC Analysts, as applicable.
• Complete documentation in accordance with current Good Manufacturing Practices (cGMP).
• Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance, inventory and ordering of supplies, etc.
• Maintain QC Microbiology related systems in compliance with industry standards.

Other Responsibilities:

• Act as deputy for the QC Manager with regards to QC Microbiology matters (in absence of QC Manager, Microbiology).
• Represent QC at inter-departmental meetings and interact with external vendors as necessary.
• Raise change control and deviations related to QC Microbiology operations including assisting with laboratory and OOS investigations.
• Assist in regulatory audits/inspections, as needed.
• Troubleshooting of equipment and QC methods.
• Train other QC Analysts within scope of knowledge.

Educational Requirements:

• BA or BS in Microbiology or other related science, preferably with Microbiology modules or coursework as part of the study program.

Experience and Skill Requirements:

• Three to five years of Microbiology laboratory-based experience in a QC testing capacity.
• Excellent microbiological skills and technical experience is a must.
• Thorough understanding of industry testing requirements for QC Microbiology and experience of cGMP.
• Computer literacy (MS Word and Excel), good communication and organizational skills.
• Ability to work well independently and with others in a team.

REVISION HISTORY

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

Salary Range

Replimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $92,500 - $120,000The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.

At Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.

About Replimune

Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.