Senior Principal Engineer/Associate Director, Drug Product MSAT

About the Company

Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Responsibilities

• Provide technical expertise for phase-appropriate drug product process development, characterization, validation, and technology transfer for sterile drug product (DP)
• Assess and manage process risks arising from manufacturing or process changes
• Serve as a primary or supporting technical interface with external CDMOs and internal manufacturing teams
• Lead or significantly contribute to implementation of process, product, and site changes across the product lifecycle
• Support and guide execution of clinical and commercial batch manufacturing activities
• Assist in the authorship, data verification, update, and/or 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
• Manage process deviation investigations and change controls
• Travel as needed to support technology transfer and process scale-up

Requirements

• Bachelor’s degree in chemical engineering, biotechnology, pharmaceutical science, or a related field
• Minimum of 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
• Strong communication, management, and interpersonal skills
• Ability to work under pressure and deliver high-quality results to tight deadlines

Preferred Qualifications

• Advanced degree (Masters or PhD)
• IND/IMPD and BLA/MAA Module 3 authorship experience
• Continuous Process Verification planning and execution experience
• Data Analytics experience including JMP or other data organization platforms