Senior Quality Control, Microbiology Analyst

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k match

Flexible time off

Paid holidays

Job summary

Replimune is seeking a Senior QC Microbiology Analyst to join our Framingham facility on-site. You will perform routine QC microbiology testing, environmental monitoring, and support cGMP compliance in a fast-paced production environment.

Two to five years of microbiology lab experience, strong attention to detail, and proficiency with MS Word/Excel are required; we offer competitive pay, benefits, and an equity component.

Qualifications

• BA or BS in Microbiology or related science.
• 3–5 years of Microbiology lab experience in QC.
• Solid understanding of QC testing and cGMP.

Responsibilities

• Set up and maintain QC microbiology laboratories and systems.
• Schedule and oversee environmental monitoring testing.
• Perform routine QC microbiology sampling and testing (bioburden, endotoxin, growth promotion, Gram stain, identifications).
• Perform water sampling and related testing (pH, conductivity, nitrates, metals).
• Test gas supplies for manufacturing suites; trend and report environmental data.

Skills

Microbiology

cGMP

Documentation

Communication

Teamwork

Education

BA/BS in Microbiology

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.

patient’s lives depend on it.

At Replimune, We Live By Our Values

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,

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

• 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 - $120,000 The 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.

• medical
• dental
• vision insurance
• 401k match
• flexible time off
• paid holidays including year-end shutdown

For more information, please visit www.replimune.com.

We are an Equal Opportunity Employer.