Senior Engineer, Technical Operations

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 becausepatient’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:

The Technical Operations Senior Engineer will be responsible for providing drug substance, drug product, and/or secondary packaging 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.

Key responsibilities:

· Cross functional leadership and technical oversite of an oncolytic virus manufacturing process at the site’s manufacturing facility.

· Manage technology transfer and post transfer manufacturing support. Provide technical leadership in troubleshooting issues with 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 technological innovation and application of experimental findings

· Monitor commercial process performance, perform evaluation of continuous process verification data and trends, investigate possible variability and identify opportunities for process improvement.

· Conduct process optimization modeling and lead implementation of process improvements.

· Serve as a subject matter expert to support manufacturing operations with technical evaluation of change controls, deviations, corrective and preventative actions

· Collaborate cross functionally with other departments to ensure efficient execution of commercial manufacturing process and transfer of new assets and process enhancements.

· Author protocols, reports, SOPs, and other technical documentation

· Lead and facilitate process risk assessments (e.g., FMEA, risk analyses, and impact assessments) to identify potential risks, implement mitigation strategies, and support robust process performance, product quality, and regulatory compliance.

· Assist with authoring sections of applicable regulatory filings to support change requests to the commercial process

· Support the review, assessment, and implementation of supplier change notifications to ensure compliance, product quality, and continuity of supply.

· Support Process Performance Qualification (PPQ) and commercialization activities, including technology transfer, process validation, manufacturing readiness, and cross-functional execution to ensure successful product launch and sustained commercial performance.

· Additional duties and responsibilities as required

Other responsibilities

· 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

Educational requirements:

· Master’s degree in chemical or biomedical engineering and 4 to 6 years of related work experience or Bachelor’s degree in chemical or biomedical engineering and 6 to 8 years of related work experience

Experience and skill requirement:

· Minimum of 4 years working in biologics drug substance and/or drug product process development / manufacturing support role.

· Experience with setting up, supporting, and troubleshooting multiple pieces of drug substance, drug product and or packaging equipment (e.g. production bioreactors, TFF skids, chromatography skids, fill machine)

· Experience with single-use manufacturing technologies

· Experience with process validation lifecycle activities, including process characterization, Process Performance Qualification (PPQ), Continued Process Verification (CPV), and commercialization.

· Experience conducting process risk assessments using tools such as FMEA, risk analysis, and change impact assessments.

· Strong technical writing skills with experience authoring and reviewing validation protocols, reports, risk assessments, and technical documentation.

· Proficiency with data analysis and statistical tools (e.g., JMP, Excel,) for process performance evaluation and decision-making.

· Experience supporting commercial manufacturing processes in a regulated environment.

· 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

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 $146,000 -$189,000. 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. 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.