Senior Principal Engineer​/Associate Director, Drug Product MSAT

Senior Principal Engineer/Associate Director, Drug Product MSAT

Princeton, NJ

Summit Therapeutics Inc. is a biopharmaceutical oncology company focused on improving quality of life and addressing unmet medical needs. Our core values include integrity, passion for excellence, purposeful urgency, collaboration, and a commitment to people.

Summit is engaged in multiple global Phase 3 clinical studies, notably in non-small cell lung cancer (NSCLC) therapies such as ivonescimab. Our headquarters are in Miami, Florida, with additional offices in California, New Jersey, the UK, and Ireland.

We are seeking a highly experienced Senior Principal Engineer/Associate Director of MSAT - Drug Product to lead process development, technology transfer, validation, and regulatory interactions for our main asset’s commercialization and batch production.

• Provide technical expertise for phase-appropriate drug product process development, characterization, validation, and technology transfer for sterile drug product.
• Assess and manage process risks arising from manufacturing or process changes.
• Serve as primary or supporting technical interface with external CDMOs and internal manufacturing teams.
• Lead or contribute significantly to implementation of process, product, and site changes across product lifecycle.
• Support and guide execution of clinical and commercial batch manufacturing to meet development and supply timelines.
• Assist in authorship, data verification, update, and review of regulatory filings.
• Provide technical feedback during regulatory agency inquiries.
• Lead PPQ execution and manufacturing oversight in alignment with GMP and quality system requirements through person in plant.
• Collaborate closely with Regulatory, Quality, Supply Chain, and other CMC functions to ensure integrated planning and execution.
• Ensure GMP compliance across all assigned activities.
• Support audits, inspections, and continuous improvement initiatives.
• Manage process deviation investigations and change controls.
• Travel as needed to support technology transfer, process scale-up, and collaboration with external partners.
• All other duties as assigned.

• Bachelor’s degree in chemical engineering, biotechnology, pharmaceutical science, or related field required; advanced degree (Master’s or PhD) preferred.
• Minimum 10+ years of relevant experience within the life sciences industry.
• Demonstrated experience in process development, MSAT, and/or manufacturing with a focus on sterile drug product and late-phase development (preferably mAbs).
• Experience with technology transfer across different systems, scales, and sites.
• Experience in late-stage process development, characterization, and validation.
• IND/IMPD and BLA/MAA Module 3 authorship experience and CPV planning and execution.
• Data analytics experience, including JMP and other data organization platforms.
• Strong communication, management, and interpersonal skills to influence across the organization and with CDMOs/CMOs.
• Excellent attention to detail and organizational skills, focusing on quality and technical excellence.
• Good information-management and data organization skills.
• Exceptional interpersonal skills for working individually or within multi-disciplinary teams and with external partners and regulators.
• Track record of working under pressure and delivering high-quality results to tight deadlines.

Pay: $180,000 - $195,000 USD (annual salary). Actual compensation may vary based on experience, location, and other factors, and may include bonus, stock, benefits, and other variable components.

Summit Therapeutics Inc. is an Equal Opportunity Employer. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.