Sr. Scientist, Process Development & Technology

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 Process development and Technology Senior Scientist- Material attributes and Technologies will be responsible for providing drug substance and/or drug product process technical support for oncolytic virus manufacturing. This includes material compatibility assessment, development of control strategies for materials used in the manufacturing, process characterization, DS/DP process development, life cycle management of commercial processes, including ownership and support of risk assessments, change controls, CAPAs and deviations. In addition, there will be opportunities to lead and support new process technology  introduction projects.

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

Responsibilities

Key responsibilities:

• Serve as the material subject matter expert in defining the suitability, compatibility and robustness for use of processing materials and support manufacturing operations with technical evaluation of change controls, deviations, corrective, and preventative actions, and supplier change notifications.
• Provide cross functional leadership & technical support to the development of control strategies for predominantly single use disposable materials used in the clinical and commercial manufacturing of Replimune products.
• Lead technical material risk assessments to consider impact to supply, processes, products, and customers.
• Provide technical expertise to troubleshoot material issues within drug substance and drug product production.
• Interface with contract research organizations (CROs) to evaluate, test, and assess extractables and leachables from polymeric/plastic component materials used in the production process. Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through technological innovation and application of alternative technologies.
• Support drug substance and/or drug product manufacturing process technology transfer and post transfer manufacturing support. Provide technical leadership in troubleshooting issues with product processing technologies and equipment.
• Drive continuous improvement in our cGMP process steps by identifying and implementing process improvements through technological innovation and application of experimental findings.
• 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, risk assessments, SOPs, and other technical documentation.
• Assist with authoring sections of applicable regulatory filings.
• 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.

Qualifications

Education:   

• PhD in chemical or biomedical engineering, chemistry, biochemistry, biotechnology, pharmaceutics or related subject area and 4 to 5 years of related work experience

OR

• Master’s degree in chemical or biomedical engineering, chemistry, biochemistry, biotechnology, pharmaceutics or related subject area and 5 to 6 years of related work experience

OR

• Bachelor’s degree in chemical or biomedical engineering, chemistry, biochemistry, biotechnology, pharmaceutics or related subject area and 6 to 8 years of related work experience

Required Experience: 

• Minimum of 4 years working experience with a materials science role, preferably in a biologics drug substance and/or drug product process development/manufacturing support role.
• Experience with materials of construct (e.g., plastics) evaluations of single-use manufacturing technologies.
• Experience with applying risk management methods and tools.
• Data analysis with statistical methods
• Demonstrated ability to work in cross-functional teams across the business.
• Strong organizational skills and attention to details.
• Excellent written and oral communication skills and strong team player.

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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