[ref. b09472820] Technical Operations Engineer I/II
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. We imagine a world where cancer is a curable disease.
At Replimune, we live by our values:
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.
Job Summary:
The Technical Operations Engineer I/II will be responsible for providing drug substance and/or drug product technical support for oncolytic virus manufacturing. This includes life cycle management of commercial processes, including ownership and support of change controls, CAPAs and deviations.
This position is based in our Framingham location and typically has a 5-day on-site expectation.
Responsibilities:
Key responsibilities:
- Support oncolytic virus drug substance and/or drug product manufacturing process technology transfer and post transfer manufacturing support.
- Provide technical expertise in troubleshooting issues with drug substance and/or drug product processing technologies and equipment.
- Provide effective life cycle management through CAPA/Change Control execution and deviation resolution
- Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through change requests or technology builds for commercial processes
- Monitor commercial process performance and perform evaluation of continuous process verification data and trends
- Serve as a subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective and preventative actions.
- Coordinates cross functionally with other departments to achieve company goals.
- Author protocols, reports, risk assessments, SOPs, and other technical documentation
- Assist with authoring sections of applicable regulatory filings to support change requests to the commercial process.
- Additional duties and responsibilities as required.
- Practices and promotes safe work habits and adheres to safety procedures and guidelines.
- Provide technical representation during internal and external audits.
- Keeps up to date with current technologies and trends in biologics manufacturing operations and support.
Qualifications:
Education:
- Master’s degree in chemical or biomedical engineering or equivalent and 0 to 3 years of related work experience or Bachelor’s degree in chemical or biomedical engineering or equivalent and 2 to 5 years of related work experience.
Required Experience:
- Minimum of 2 years working in biologics drug substance and/or drug product technical operations / MSAT / process development / manufacturing support role.
- Experience with setting up, supporting, and/ or troubleshooting multiple pieces of drug substance and/or drug product manufacturing equipment (e.g. production bioreactors, TFF skids, chromatography skids, fill machine)
- Experience with single-use manufacturing technologies.
- Demonstrated ability to work in cross-functional teams across the business.
- Strong organizational skills and attention to detail.
- Excellent written and oral communication skills and strong team member.
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.
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