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Sr. Director Global Validation & Technical Services-Cell Therapy

Adaptimmune Philadelphia, PA
  • Posted: over a month ago
  • Full-Time
Job Description

Primary Responsibility

We are looking for an experienced expert in product development lifecycle and validation to lead the Quality Technical Services function at Adaptimmune.   We specialize in T-cell therapeutics for oncology and have multiple early and late phase clinical trials in the US and Europe.  Direct experience in establishing the validation lifecycle for Advanced Therapy Medicinal Products (ATMP), particularly in the area of cell therapy is essential, as is experience in product control strategy development, equipment qualification, aseptic processing, analytical methods (particularly Flow Cytometry) and application of risk assessment in development of lifecycle strategies.  Competitive compensation package is available.

This position is based in Philadelphia PA with key collaborations in Philadelphia PA, Stevenage UK, and Milton Park UK.

Key Responsibilities

Key strategic leader responsible for the T-Cell and Vector Lifecycle Management functions within the Quality Unit at Adaptimmune with staff located in the US Navy Yard and UK Stevenage Facilities.  The primary focus of the leader will be to advance comprehensive lifecycle strategies in support of the Adaptimmune early and late phase product portfolio.

In collaboration with technical heads in Quality Control, Process Development, MS&T and Manufacturing, establish and maintain essential lifecycle documentation including QTPP, Control Strategy, risk assessments, validation plans, protocols, and associated reports.

Define and execute strategies for effective stewardship of analytical methods used for vector and drug product release, stability and characterization.

Ensure regulatory claims are supported with applicable data and actions

Serve as the Adaptimmune subject matter expert for the product development lifecycle applicable to vector and T-Cell processes with particular focus on strategies that facilitate innovation within the Adaptimmune product portfolio.

Ensure that external contract manufacturers understand and implement Adaptimmune’s requirements for validation and lifecycle documentation.

Establish strategies required for control strategy development including establishment of critical process parameters, proven acceptable ranges, and critical quality attributes in order to facilitate regulatory submissions including IND, IMPD, MAA and BLA.

Provide company representation at regulatory and industry organizations involved in setting standards for the advancement of ATMPs toward commercialization.

Responsible for the Specification Committee and key member of the Material Review Board.

Qualifications & Experience

Required

  • Degree in Engineering or Science, PhD in cell/molecular biology preferred.
  • Experience in biologics, vaccines, or gene/cellular therapy field.
  • 10+ years’ experience in leading/managing multidisciplinary teams.
  • An effective strategic leader with a clear record of having managed a diverse portfolio of company critical projects.
  • Experience managing analytical methods transfer, qualification, and validation for biological products. Specific experience with potency assays for cell therapies is strongly desired.
  • Deep experience supporting the development of regulatory documentation including IND, IMPD, BLA and CTD.  Experience with post approval changes is desired.
  • Experience in face-to-face communications with regulatory agencies including direct experience representing complex validation strategies to regulators.
  • Experience leading the commissioning, validation and start-up of aseptic processing facilities.
  • A passion for addressing the critical unmet medical needs of patients.

Desirable

  • Development of BLA sections for a complex cell therapy product.
  • Experience facilitating post approval changes for US and EU approved products.

Skills & Competencies

Required

  • Recognized expert in the application of the process validation lifecycle supporting complex biologic products. 
  • Deep understanding of and experience establishing validation strategies compliant with current European and US FDA guidance for process validation. 
  • Expertise in worldwide requirements for manufacturing, analytical methods, stability, and technology transfer.
  • Expert in technology transfer, qualification, and validation of compendial and bespoke analytical methods with a particular understanding of assays used for cell therapies. 
  • Strong planning and resource management skills in a dynamic project environment located across multiple geographies.
  • Strong communication skills and a “do-what-it-takes” attitude that inspires others.
  • Self-directed individual who is able to work with limited direction in a fast-paced, goal-oriented environment.

decision making authority

  • Final decision maker and representative of the Quality Unit for the early and late stage programs at Adaptimmune as it relates to lifecycle strategies.
  • Approval of CMC sections of regulatory filings, validation protocols and reports, and applicable procedures related GMP operations, analytical methods, and validation.
  • Approval of Master Batch Production Records to ensure lifecycle documentation is appropriately reflective of the control strategy, particularly the final product specification, CPPs and CQAs.
  • Serve as the final approval to advance programs into and between lifecycle stages. 
  • Owner of all policies related to product, vector, and analytical methods lifecycle.

Size and scope of team (including number of direct reports)

5 Direct reports encompassing approximately 25 staff (20 US 5 UK).  Functions include:

  • T-Cell Lifecycle and Quality Engineering (US)
  • Vector Lifecycle and Quality Engineering (UK)
  • Quality Control Analytical Science and Technology (US)
  • Product Characterization (US)
  • Equipment and Facilities Validation (US)

other requirements

Travel is expected to be 25% (US and UK).

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

 

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

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Adaptimmune

Address

Philadelphia, PA
19112 USA

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