Director, Vector Development

Primary Responsibility

This role is to provide strategic and operational leadership to the Vector Development group at Adaptimmune. The scope includes the day to day management of the upstream and downstream process development teams, oversight and review of the Vector Development projects, strategic updating Adaptimmune’s vector development roadmap and interfacing with other key functions (MS&T, Manufacturing, Quality and Regulatory), and especially focusing on the tech transfer of new processes and innovations out of process development.

Key Responsibilities

  1. Day to day management and leadership of the of the bioprocess development function within the vector development team – 20%
  2. Lead project governance of all vector development projects. Provide technical review of experimental designs, results, conclusions and the process development plans of the bioprocess development function within Vector Development – 25%
  3. In conjunction with their team provide strategic direction for vector bioprocessing at Adaptimmune to drive increased process optimisation, process understanding and decreased COGS – 20%
  4. Work collaboratively with the Vector MS&T on the tech transfer of new process into GMP manufacturing – 15%
  5. Manage any outsourced development activities for vector bioprocessing with subcontractors – 20%

 

Qualifications & Experience

Required

  • BSc or higher qualification in relevant area.
  • Experience with bioprocess development in the gene therapy, vaccine and/or biopharmaceutical fields, significant relevant industrial experience is required.
  • Depth of expertise in people leadership and development is also key to this role.

The role requires a depth of experience in the process development, optimization, scale-up and technology transfer of bioprocesses. The role would lead the vector bioprocess development effort within Vector Development group and would be responsible for the development of the entire bioprocess including the upstream production of the vector and downstream purification and concentration unit operations. Therefore a deep understanding of technologies suitable for scale-up of bioprocesses is required including

  • bioreactors (suspension or adherent based cell culture),
  • chromatography
  • dead-end / tangential flow filtration is required.
  • significant knowledge and experience of the scale-up and scale-down of upstream and downstream unit operations

Desirable

  • Experience in live virus or gene therapy product formulation would be an advantage.
  • Knowledge of viral vector biology and molecular biology would be an advantage but is not essential.
  • Experience of assisting in the authoring of regulatory submissions (IND/IMPD) would also be a significant advantage.
  • Experience of BLA/MAA preparation including process understanding, risk assessment and control strategy implementation with any category of biopharmaceutical (recombinant protein, vaccine or an ATMP) would also be an advantage.

 

Skills & Competencies

Required

  • The relevant skills and competencies to provide line management of a process development team are necessary. These skills include the ability to, motivate, delegate, and provide personal development insight for direct and indirect reports. Furthermore the ability to simultaneously improve both efficiency and quality within the team are required through driving efficient team work is required.
  • The role requires an excellent communicator who is able to provide clear messages, both internally and to external partners.
  • Skills and knowledge relating to the development, scale-up and tech transfer of bioprocesses destined for GMP manufacture are key for this role. These skills should include the ability to critically examine in-process data, evaluating both yield and product quality leading to a risk based approach to further optimise and understand the bioprocess. An attention to detail is also key to enable thorough review of development reports, tech transfer documents and batch records.

Desirable

  • Knowledge of statistical experimental design (such as DoE) would be a significant advantage.

 

Decision Making Authority

  • The responsibility of the role is to provide the leadership of the Vector Development group.
  • Size and scope of team  :4 direct reports and up to 10 indirect reports

 

Other Requirements

Travel to CMOs and conferences is likely to be required.

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