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Location

Boston, Lincolnshire | United Kingdom

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Job description

EPM Scientific is partnered with a small biopharmaceutical company dedicated to pioneering advancements in therapeutic solutions. With a significant focus on Antibody-Drug Conjugates (ADCs), the team seeking a Manager of Process Development to lead tech-transfer, process characterization, scale-up, and CDMO management for late-stage ADC development.

Responsibilities:

• Lead and manage the successful transfer of ADC processes from development to manufacturing, collaborating with internal and external partners.
• Ensure alignment between development and manufacturing teams for a smooth transition of processes.
• Design and execute robust process characterization studies to understand critical process parameters and optimize process performance.
• Implement statistical methodologies to ensure process robustness and reliability.
• Oversee the scale-up of ADC processes to meet the demands of late-stage clinical trials and commercial production.
• Identify and address scale-up challenges to maintain product quality and yield.
• Work closely with analytical development, quality, regulatory affairs, and manufacturing teams to integrate processes seamlessly.
• Collaborate on the implementation of process improvements and technology advancements.

Qualifications:

• Ph.D. in a relevant scientific or engineering discipline with a minimum of 6 years of experience in biopharmaceutical process development, specifically focused on ADCs.
• Proven expertise in successful tech transfer and scale-up of ADC processes in late-stage development.
• Strong background in process characterization and statistical methodologies.
• Experience with regulatory requirements for late-stage development and commercial manufacturing of biologics.
• Excellent leadership, communication, and interpersonal skills.

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Job tags

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Salary