About LabCorp Drug Development

As a leading contract research organization, LabCorp provides comprehensive drug development solutions for a range of industries. We are a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Together with our clients, we support the development of innovative, life-changing treatments.

The Role

Our UK site in Harrogate, North Yorkshire is currently recruiting for a Senior Assay Development Scientist, specialising in cell based potency assays, to join the CMC(Chemistry Manufacturing Controls) team.  

The CMC business unit provides dedicated release and stability testing from preclinical phases through the commercial life of a product. The CMC team support method development, transfer, phase appropriate validation & assay establishment of large molecules. We structure ourselves to deliver scientific expertise to our clients; collaborating closely with them to support the development of medicinal products through the drug development process and onto market.

Job responsibilities include

• Development and establishment of cell-based potency assays within BioPharm CMC that demonstrate the biological function of therapeutics

• Development and optimisation of analytical methods, in accordance with client requirements and associated protocol and procedures

• Acting as a Subject Matter Expert in cell-based methods.

• Managing the scientific process associated with studies assigned to them, including review and approval of data and documentation where relevant

• Liaising with clients, the QC operations teams, project managers and GMP Quality Assurance to ensure client studies are carried out to proposed timescales and regulations

• Managing the scientific discussion with clients and providing advice on scientific escalation and assay troubleshooting where necessary

 What Labcorp Drug Development can offer you

• A comprehensive onboarding training plan covering laboratory, technical and regulatory training packages.

• Unsurpassed career development opportunities, with the ability to develop your technical and managerial skills.

• Ability to work with a variety of different clients on wide ranging projects.

• Competitive salaries and a comprehensive benefits package including health cover and contributory pension.

Education/Experience

• Educated to BSc/MSc/PhD in an appropriate scientific field

• Proven experience in the development of cell based potency assays directly related to advanced medicinal products

• You will be able to clearly demonstrate your skillset and success in the development of fit-for-purpose plate-based bioassays to determine product potency

• Excellent communication skills, with the ability to work with individuals in wide ranging teams at all levels and the ability to lead and influence

• In depth knowledge of GMP regulatory guidelines applicable to analytical methods

• A quality by design approach is a pre-requisite together with an understanding on potency assay validation requirement.

• Extended experience in the development of potency assays  for one n or more of the following therapeutic areas is a distinct advantage:  Adeno-associated virus (AAV), Lentivirus, Chimaeric Antigen Receptor (CAR) T-Cells, lipid nanoparticles, exosomes, nucleic acid therapies and vaccines.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.