Principal Scientist - CMC

Whittlesford - UK

Monthly Salary: Not Disclosed

Posted on: 19-09-2025

Vacancies: 1 Vacancy

Job Summary

The Role

The Principal Scientist will be a key member of the development team responsible for leading CMC activities for selected monoclonal antibodies within the companys portfolio. They will guide the selection of suitable 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 teams 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.

Responsibilities

Lead CMC projects to meet Alchemab development project goals and timelines.
Guide selection implementation of external contractors including CROs/CDMOs reviewing contracts and quality agreements.
Able to adapt to the changing requirements of Alchemabs 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.

Essential

A highly competent and organised self-starter with extensive biologics CMC experience and strong cross-functional communication skills to support antibody development activities.
Advanced experience of upstream and downstream processes for biologics in Chinese Hamster Ovary (CHO).
Extensive knowledge of state-of-the-art approaches to assess the developability/manufacturability assessment of monoclonal antibodies.
Excellent knowledge and experience of CMC development of monoclonal antibodies through process development and GMP manufacturing scale up.
Demonstrated expertise in managing outsourced activities on a day-to-day basis with responsibility for multiple projects at varying stages of development in parallel

Desirable

Experience contributing to early clinical planning strategies.
Skilled in implementing and working within fit for purpose quality management.
Strong knowledge of current and emerging regulatory standards and requirements for phase I/II clinical studies experience filing regulatory documentation with global regulatory agencies (FDA EMA MHRA etc.).
Experience overseeing drug product fill-finish packaging and labelling activities for clinical supply.

Qualifications

PhD in a biological discipline plus experience in a relevant area or equivalent relevant

industry experience 5 years. Strong background in biologics CMC manufacturing processes.

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 if you think you can help in the future.

Required Experience:

Senior IC

The Role The Principal Scientist will be a key member of the development team responsible for leading CMC activities for selected monoclonal antibodies within the companys portfolio. They will guide the selection of suitable CDMOs to outsource CMC projects taking molecules through cell line developm...