Principal Scientist - CMC in Whittlesford

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The Principal Scientist will be a key member of the development team, responsible for leading CMC activities for selected monoclonal antibodies within the company’s portfolio. They will guide the selection and management of external CDMOs to outsource CMC projects, taking molecules through cell line development to scale up for GMP manufacturing. The role includes leading the transfer of preclinical research know-how of lead candidates from Alchemab research teams to external CDMOs and serving as the team’s CMC technical expert. With a strong focus on product quality and safety, the Principal Scientist will be responsible for ensuring successful process and formulation development, analytical development, technology transfer, manufacturing, and regulatory submissions.

The Principal Scientist will have the unique opportunity to be involved from the outset in growing the development function within a fast-growing, dynamic biotech environment.

• Lead CMC projects to meet Alchemab development project goals and timelines.
• Guide selection and implementation of external contractors including CROs/CDMOs, reviewing contracts and quality agreements.
• Able to adapt to the changing requirements of Alchemab’s programmes through research and development stages in a fast-paced environment.
• Support manufacturability and developability assessments of our products at CDMOs and in house for lead candidate selection and transfer to CDMOs. Responsible for transferring the project and know-how to select CDMOs for establishing assays and process development planning.
• Work as a key member of our development teams, plan and lead CMC campaigns which are currently outsourced to CDMOs, working closely with them as the point of contact for each project.
• Review CDMO project plans, reports and documentation, contributing to troubleshooting throughout CMC drug substance and drug product stages.
• Prepare and regularly review CMC team budgets, forecasting long-range plans and budgets for manufacturing.
• Lead CMC regulatory documentation in preparation for phase I/II clinical studies across different global regions and contribute to the regulatory submissions.
• Demonstrate extensive biologics CMC experience and strong cross-functional communication skills to support antibody development activities.
• Advance experience of upstream and downstream processes for biologics in Chinese Hamster Ovary (CHO) systems.
• Apply knowledge of state-of-the-art approaches to assess the developability/manufacturability of monoclonal antibodies.
• Demonstrate expertise in CMC development of monoclonal antibodies through process development and GMP manufacturing scale up.
• Manage outsourced activities on a day-to-day basis, coordinating multiple projects at varying stages of development in parallel.
• Contribute to early clinical planning strategies.
• Implement and operate within fit-for-purpose quality management systems.
• Maintain a strong understanding of current and emerging regulatory standards for phase I/II studies and support regulatory filings with global agencies (FDA, EMA, MHRA, etc.).
• Oversee drug product fill-finish, packaging, and labeling activities for clinical supply.

PhD in a biological discipline plus relevant industry experience of 5+ years. Strong background in biologics CMC manufacturing processes.

Alchemab has developed a highly differentiated platform which enables the identification of novel drug targets and therapeutics by analysis of patient antibody repertoires. The platform uses well-defined patient samples, deep B cell sequencing, and computational analysis to identify convergent protective antibody responses among individuals that are susceptible but resilient to specific diseases.

Alchemab is building a broad pipeline of protective therapeutics for hard-to-treat diseases, with an initial focus on neurodegenerative conditions and oncology. The highly specialized patient samples that power Alchemab’s platform are made available through valued partnerships and collaborations with patient representative groups, biobanks, industry partners, and academic institutions.

The company is based and headquartered in Cambridge, UK with Dr. Jane Osbourn as CEO.

NOTE: This job description is not intended to be all inclusive. Employees may perform other related duties as negotiated to meet the ongoing needs of the organisation.

Note to recruitment agencies: we are not looking for assistance at this stage so please contact the HR department only at hr@alchemab.com if you think you can help in the future.