Principal Scientist, Vector Process Development

2 weeks ago

Abingdon, United Kingdom Adaptimmune Full time

Primary Responsibility


 

Functional focus: The Vector Process and Analytical Development team is responsible for developing, characterising vector manufacture to support Adaptimmune’s cell based drug product manufacture.

The primary purpose of this role is to lead and provide late phase development expertise on cross-functional projects across the Vector Process and Analytical function, including leading technical transfer of protocols and methods to GMP laboratories, authoring IND submissions and supporting BLA submissions.

The Principal Scientist will be accountable for the progression of project work streams to solve complex problems and/or troubleshoot existing processes within dedicated teams.

The candidate will be expected to have experience of working in a matrix management environment. The Principal Scientist will work collaboratively with the team leadership to ensure a cohesive workstream strategy and alignment to project delivery.

This role will require the supervision/mentorship of other junior scientists in a matrixed manner within the team, working closely with their line managers.

Performance in this role (including functional and project objectives and behaviours) will be monitored through group performance and stakeholder feedback from peers, senior management and workstream team members.



Key Responsibilities Leading the planning, execution and delivery of Late Phase development activities Able to collate and share knowledge needed to enable others to deliver their objectives Demonstrate communication appropriate to the purpose and audience Supervision/mentorship of other junior scientists, and project work-stream leadership/management In partnership with the Director/Associate Director designing experiments appropriate for the individual function and/or discipline to enable group and/or project objectives Qualifications & Experience

Required Degree in Biological Sciences Direct experience of writing documents submitted to regulatory bodies e.g. IND Relevant post-graduate experience within academic or industry setting. Desirable Tech transfer of vector manufacturing processes to GMP laboratories Tech transfer of vector analytical methods to GMP laboratories Small scale model qualification Practical experience of lentiviral vectors GMP experience. Scientific project and/or people leadership experience. Experience of implementation of CMC and Regulatory requirements for viral vector manufacture in cell/gene therapy. Skills & Competencies

Ability to write and follow standard operating procedures and experiment plans. Knowledge and skills in the use of standard laboratory equipment (such as pipettes, pH meters, centrifuges). Ability to design experiments and studies to address key scientific questions. Experience and understanding of ‘Quality by Design’ approaches. Experience with process design software tools. Advanced experimental design skills (e.g. design of and execution of multifactorial experiments) Advanced data analysis and interpretation skills, including attention to detail. Ability to write study plans and protocols. Good time management skills. Strong team player, but with the ability to work independently as necessary. Excellent communication skills (both written and verbal). Excellent numeracy and English language skills (both written and verbal). Computer literate and ability to familiarise with different IT systems.
Desirable
  Familiarity with more specialist lab equipment e.g. flow cytometers, bioreactors, filtration systems, TFF, chromatography. Ability to plan and progress studies in an efficient manner to achieve objectives in the context wider department objectives and company goals. Work-stream leadership and planning experience
other requirements Occasional travel for tech transfer purposes may be required.

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