Sr. Scientist, Process Development & Technology

Replimune Limited - Framingham, MA

Full-time - Senior

Framingham, MA

About the position

The Process Development and Technology Senior Scientist at Replimune will play a crucial role in providing technical support for the manufacturing of oncolytic viruses. This position focuses on material compatibility assessments, development of control strategies, and process characterization, ensuring the robustness and suitability of materials used in drug substance and drug product manufacturing. The role also involves leading new process technology introduction projects and collaborating cross-functionally to enhance manufacturing processes.

Responsibilities

• Serve as the material subject matter expert in defining the suitability, compatibility, and robustness for processing materials.
• Support manufacturing operations with technical evaluation of change controls, deviations, corrective, and preventative actions, and supplier change notifications.
• Provide cross-functional leadership and technical support to develop control strategies for single-use disposable materials used in manufacturing.
• Lead technical material risk assessments considering impacts 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 materials used in production.
• Drive continuous improvement in cGMP process steps by identifying and implementing process improvements through technological innovation.
• Support drug substance and/or drug product manufacturing process technology transfer and post-transfer support.
• Provide technical leadership in troubleshooting issues with product processing technologies and equipment.
• Collaborate cross-functionally to ensure efficient execution of commercial manufacturing processes and transfer of new assets and enhancements.
• Author protocols, reports, risk assessments, SOPs, and other technical documentation.
• Assist with authoring sections of applicable regulatory filings.

Requirements

• PhD in chemical or biomedical engineering, chemistry, biochemistry, biotechnology, pharmaceutics, or related subject area with 4-5 years of related work experience; OR a Master's degree with 5-6 years of experience; OR a Bachelor's degree with 6-8 years of experience.
• Minimum of 4 years working experience in a materials science role, preferably in biologics drug substance and/or drug product process development/manufacturing support.
• Experience with materials of construct evaluations of single-use manufacturing technologies.
• Experience 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 detail.
• Excellent written and oral communication skills.

Nice-to-haves

• Experience with biologics manufacturing operations.
• Familiarity with regulatory compliance and audit processes.

Benefits

• Competitive salary and total rewards program.
• Opportunities for professional development and growth.
• Collaborative and innovative work culture.