Sr. Manager, Quality Control

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. We imagine a world where cancer is a curable disease.

United:
We Collaborate for a Common Goal. Audacious:
We Are Bold and Innovative. 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, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients.

Join us, as we reshape the future.

The Sr. Manager, Quality Control has the responsibility of managing and overseeing the work of direct reports, managing individuals or a team, leading method transfer and validation activities, stability study coordination, management of external testing, writing and approving CoAs, assay control, reference material and sample management, writing, reviewing and approving various QC related documents as required.

This role also requires performing QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) as required, setting up and maintaining systems and processes for QC Laboratory, scheduling, review and approval of test results, management of the QC laboratory and interactions with other groups.

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

• Manage direct reports including their training, scheduling of work, coaching as well as leading them to achieve departmental goals and objectives
• Lead QC assay transfer/validation activities to introduce new assays into QC lab within given time frame
• Set-up GMP compliant QC processes and maintain them appropriately for audit readiness
• Review and approve QC test data and CoA (Certificate of Analysis)
• Write, review and QC approve change controls, CAPA, deviations, protocols, reports forms and templates related to QC operations as applicable
• Lead investigations for OOS (Out of Specification), OOT (Out of Trend) results in timely manner
• Participate in regulatory inspections and submissions
• Oversee and manage maintenance of QC laboratory and equipment
• Lead QC laboratory equipment introduction and participate in equipment validation
• Oversee sampling and storage of QC samples and maintain inventory
• Coordinate shipping and receipt of QC samples and other QC related material
• Training others within department on methods and processes in accordance with GMP practices
• Become SME for QC methods, monitor method performance and lead trouble shooting/ method optimisations as required
• Interact within internal as well as across other functional groups to communicate QC requirements
• Deputize for other roles during periods of absence or when responsibilities have been delegated
• Perform QC testing following Standard Operating Procedures (SOPs)
• Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP)

• Troubleshoot equipment and analytical methods
• Manage technical studies performed with external companies
• Represent QC at inter-departmental meetings and interact with external vendors, as necessary.

Education:

• BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
• More than 5 years GLP / GMP experience in a relevant work environment.

Required Experience:

• 6 years or GLP / GMP experience in a relevant work environment.
• Prior line management experience preferred.
• Computer literacy (including MS Word and Excel)
• Ability to work well with others and lead a team
• Effective communication skills
• Good organizational and time management

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

We are an Equal Opportunity Employer.