Senior Engineer, Technical Operations

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:

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.

• 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

• 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

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