Principal Scientist, Process Development and Technology

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 Principal Scientist- Drug Product will be responsible for providing subject matter expertise for the drug product development and technology transfer support for oncolytic virus manufacturing. This includes, drug product formulation development, process characterization, optimization, and validation support, ownership, and support of change controls, CAPAs and deviations, new technology evaluation and post marketing life cycle management of commercial product.This position is based in our Framingham location and typically has a 5-day on-site expectation.Key responsibilities:Provide cross functional leadership and technical oversite to support development, characterization, optimization, and validation of drug product manufacturing steps (e.g. Thawing, filtration, filling, stoppering, visual inspection, labeling, freezing and packaging of the drug products) of an oncolytic virus.Lead the design, execution, and documentation of experiments to develop stable formulations and robust manufacturing processes for preclinical, clinical supply production and to scale-up these processes to the commercial space. Serve as a subject matter expert to support drug product development, process characterization and validation of manufacturing operations with technical evaluation of change controls, deviations, corrective, and preventative actions (CAPA). Manage 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. Provide effective life cycle management through CAPA/Change Control execution and deviation resolution.Provide technical leadership in development activities to support post marketing life cycle management.Liaison to external vendors for new technology evaluation, technology onboarding, process equipment / materials specifications, user requirements, procurement and technical support. 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. Collaborate cross functionally with the Analytical Development team to develop subvisible particle characterization assays, along with other relevant assays for product characterization. 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 drug product characterization and manufacturing operations and support.Perform laboratory tasks including general housekeeping, equipment monitoring and maintenance.Some travel may be required, both in country and international.Education: PhD in chemical or biomedical engineering, chemistry, biochemistry, biotechnology, pharmaceutics, or related subject area and 6 to 8 years of related work experience.Bachelor’s or master’s degree in chemical or biomedical engineering and 8 to 10+ years of related work. Required Experience:Minimum of 6-10 years’ work experience with biologics drug product formulation development, process development, and manufacturing support role.Experience with sterile product manufacturing and aseptic techniqueExperience developing biologics drug product formulation, manufacturing processes, including advanced knowledge of key unit operations (freeze/thaw, formulation, mixing, filtration, filling, stoppering, visual inspection etc.). Experience conducting formulation development and process characterization studies with minimal supervision.Ability to work in a dynamic and fast-paced team environment and strong team player.Ability to prioritize, plan, and execute work with limited guidance.Demonstrated ability to work in cross-functional teams across the business.Strong organizational skills and attention to detail. Excellent written and oral communication skills.Desired Experience and Skills Experience with sub-visible and submicron particle characterization. Familiar with Quality by Design principles and have experience applying the Quality by Design tools and principles to products in development.Familiar with ISO, CFR, ICH, and USP guidelines as they relate to sterile products.Experience with process modeling.Experience with liquid and lyophilized drug product formulation development.Understanding of compliance and regulatory issues for sterile injectable products manufactured by aseptic processing. 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.#LI-onsite

Created: 2025-10-31