Senior Research Scientist - Biopharma Process Development

Overview

Oversee bioprocess technical transfer activities for biotechnology therapeutics programs, with a focus on 3rd party CDMOs, bridging internal process development and external manufacturing teams.

What you'll do

• Oversee all aspects of process transfer activities for biotechnology products to internal and/or external CDMOs.
• Manage all associated relationships with sending and receiving site SMEs, project leaders, and tech transfer leads.
• Author, review, and edit technical documents, protocols, and reports, ensuring compliance with Good Manufacturing Practice (GMP) or other applicable regulatory/quality requirements.
• Communicate regularly to project and technical teams, as well as senior management regarding project progress, risks, gaps, and mitigation strategies.
• Travel to both sending site and receiving site as needed to ensure successful process transfer and facilitate timely communication.

What you'll need

• Ph.D. in biology, biochemistry, biotechnology or a related field with a minimum of 5 years of experience in the pharmaceutical industry, OR M.S. in the above listed fields with a minimum of 10 years of experience.
• Demonstrated experience with either upstream or downstream process development for mammalian cell culture derived biotechnology products.
• Experience managing technical activities with external CDMOs or CDMO experience managing client projects.
• Execution or oversight of work in a regulated environment.
• Excellent communication and organizational skills; attention to detail.
• Demonstrated experience with authoring and editing technical documents.

Nice to have

• Experience in both upstream and downstream process development with CHO-cell bioprocess for mAbs and/or protein therapeutics.
• Thorough understanding of GMP requirements, quality systems, and associated regulatory structures.
• Experience with technical and process transfer of mammalian bioprocess from development to manufacturing, preferably to 3rd Party CDMOs.
• Experience with statistical approaches to experimental design (DoE) and the ability to analyze, interpret, and document complex data.
• Demonstrated ability to lead projects and contribute to technical risk assessments and root cause investigations.
• Experience working with a global technical team across multiple geographies and technical backgrounds.

Details

• Expected travel approximately 25%.
• Flexible working hours needed to accommodate global programs and stakeholders in APAC, UK/EU and USA.