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.
