About the role
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.
Summary of job description
This role includes responsibility of QC testing according to Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP), managing or overseeing the work of more junior QC staff, setting up and maintaining systems for QC laboratory, assist with scheduling, reviewing of tests results, assist in the management of the QC laboratory, participation in assay transfer and validation activities.
This position is based in our Milton Park location and typically has a 5-day on-site expectation.
Key responsibilities
- Perform QC testing following Standard Operating Procedures (SOPs).
- Assist with the maintenance of QC laboratory and equipment.
- Generate protocol and report for assay transfers/validation.
- Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
- Author and review SOPs, forms, Deviations, Change controls CAPA, CoA (Certificate of Analysis) reports
- Lead or assist with OOS, OOT, and lab investigations as needed.
- Participate in regulatory inspections and submissions, as needed.
- Lead QC laboratory equipment introduction and participate in validation activities.
- Interact within internal as well as across other functional group to communicate QC requirements.
- Manage receipt and storage of QC samples, reagents and maintain retain inventory.
- Coordinate shipping of samples to Milton Park and contract testing laboratories.
- Training others within department for methods and processes according to GMP standards.
- Become SME/Trainer for method or process and lead troubleshooting or method optimization as required
- Line management responsibility for direct reports if applicable
Other responsibilities
- Manage technical studies performed with external companies.
- Represent QC at inter-departmental meetings and interact with external vendors, as necessary.
Preferred Educational requirements
- A BA or BS in Chemistry/Biochemistry/Microbiology or other related science.
Experience and skill requirement
- 4 years or more GLP / GMP experience in a relevant work environment.
- Computer literacy (including MS Word and Excel)
- Ability to work well with others
- Effective communication skills
- Good organizational skills
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.