Senior Scientist, CMC Cell Process Analytical Development

CMC · Oxford, Oxfordshire
Department CMC
Employment Type Full-Time
Minimum Experience Experienced

Senior Scientist - CMC Cell Process Analytical Development                                           image

T-Cypher Bio is a seed-stage, innovative biotechnology company aiming to unlock an expansive target space to build a pipeline of novel, T-cell receptor (TCR)-based therapeutics. We are seeking a highly motivated Analytical scientist with experience in development and validation of methods to either ICHQ2R1, or WHO TGS-4, guidance. Experience in either Molecular or Cell based methods is desirable. Candidates should independently optimise methods, write method SOPs and experience in writing validation protocols. In this role the candidate will be working with third parties to develop and implement highly sophisticated, novel and disruptive devices, replacing the more traditional methods.

The ideal candidate is a good team player and is comfortable training out their skills and knowledge to junior team members. Knowledge and/or experience developing clinical assays is also desirable but not essential. Awareness/experience of antibody labelling is also desirable. The individual should be comfortable exploring and leading new ideas for developing and delivering CGT medicinal product. The candidate will work closely with the VP-CMC, process development and preclinical development members, to deliver critical in-process and release methods.

What you will do

  • Work with Vice President, CMC to identify analytical equipment that aligns with CMC vision and strategy
  • Work with Vice President, CMC to get Equipment Qualification process (IQ/OQ/PQ) in place
  • Help identify Critical Quality Attributes (CQA’s)
  • Review the requirements of the manufacturing process to help design panels for in-process and release analytics as well as process validation and product characterisation purposes
  • Lead analytical studies to help justify the manufacturing process
  • Work with Quality teams to help develop validation protocols
  • Lead analytical method tech transfers
  • As subject matter expert, technically lead collaborations on third party co-development therapies projects to deliver novel technologies suitable for commercialisation of gene modified cell
  • Participate in identifying and recruiting resource to build up the team as well as identify development opportunities for self and team
  • Challenge proposals at each stage of the drug development lifecycle to ensure T-Cypher are not over-engineering CMC process and analytics but also delivering methods that are fit for purpose

Key Responsibilities

  • Autonomously design and develop methods, deploying QbD principals to develop robust methods suitable for GMP environments
  • Lead on collaborations to transfer developed methods onto novel devices suitable for GMP environments
  • Write up experiments clearly in a manner to allow replication if required
  • Author/review method SOPs
  • Train and mentor junior members of the team
  • Assume responsibility of hardware ensuring the equipment is maintained and functioning optimally and those using the equipment are appropriately trained
  • Maintain awareness of latest Analytical technologies/developments that align to the CMC vision

To be successful you will need

  • Extensive experience in development and validation related to cell therapies or gene-modified cells
  • Experience in cell-based assays such as bioassays, flow cytometry, and molecular biological methods 
  • Ability to independently develop analytical methods and author method SOPs
  • Experience in writing validation protocols, executing validation studies and completing reports is desirable
  • Experience working in GxP environment would be an advantage for an appreciation of the environment methods will be developed for and awareness of ICHQ2 R1 method validation requirements is also an advantage
  • Experience working with third parties to co-develop novel consumables/reagents and method protocols
  • Knowledge and/or experience developing clinical assays is desirable
  • Awareness/experience of antibody labelling is also desirable

What we offer

  • Competitive salary and benefits
  • Modern, well equipped shared office and laboratory facilities on Oxford Science Park
  • Training and development opportunities in-line with the company’s goals and growth plans
  • An exciting opportunity to help establish an early-stage biotech with ambitions to impact patient’s lives
  • All applicants must be able to demonstrate the right to work in the UK

Thank You

Your application was submitted successfully.

  • Location
    Oxford, Oxfordshire
  • Department
  • Employment Type
  • Minimum Experience