Associate Director, Analytical Development
3 weeks ago
Adaptimmune is a fully integrated cell therapy company, designed and built from the ground up with four U.K.- and U.S.-based biotechnology hub locations. Our comprehensive capabilities and teams include preclinical research, clinical development, translational sciences, autologous and allogeneic manufacturing, and in-house commercial and corporate operations.
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
PRIMARY RESPONSIBILITY
We are looking for an Associate Director to lead our Analytical Development work within Autologous T-cell Process and Analytical Development group. Our Group is responsible for early-stage and late-stage analytical assay development/optimization and tech transfer of release and characterization testing for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness. Additional responsibilities will include authorship and/or review of CMC sections of regulatory filings and supporting documents. You will be expected to collaborate in a cross functional and matrix manner to support successful analytical development and QC testing of manufactured T-cell drug products for clinical trials across our portfolio. As a subject matter expert in analytical assay development of novel T cell products with familiarity of CMC cross-functional dynamics, you will be expected to demonstrate leadership while you provide strategic direction of analytical development activities and enable the tactical scientific assistance work of a team of Senior Scientists, Scientists and Associates, based on CMC needs.
KEY RESPONSIBILITIES
- Lead analytical assay development, optimization, qualification, and tech transfer to QC team, CRO or CMO partners for clinical stage of T cell Therapy products with a focus on pivotal and commercial readiness
- Effectively manage and mentor a diverse team of Senior Scientists, Scientists and Associates by communicating clearly, holding people accountable for their responsibilities, providing strategic guidance, enabling decision making and facilitating career development opportunities (30%)
- Review protocols, reports, risk assessments, and other related procedures for regulatory support, technology transfer, and internal use
- Collaborate with cross-functional teams across CMC, Quality, Regulatory, Translational and Research and interact with contract manufacturing organizations (CMOs) to ensure appropriate release and characterization assay implementation and conduct of analytical methods
- Author and review CMC content for IND submissions, amendments and BLA filing
QUALIFICATIONS & EXPERIENCE
Required
- Ph.D., M.Sc. or B.Sc. in cell and/or molecular biology, engineering, or relevant discipline with a minimum of 6 years (PhD), 8 years (M.S.) or 10 years (B.S.) of industry experience.
- Experience of successfully working in cross-functional teams, familiar with CMC team matrix environment and internal/external collaborations to support successful manufacturing of T-cell drug products for clinical trials.
- Excellent track record of people management and career development support.
- Expert in analytical assay development, including bioassays, qPCR/ddPCR and flow cytometry.
- Experience with method qualification and/or validation and analytical comparability
- Strong technical skills with industry experience in writing regulatory documents, including CMC sections of INDs and BLA. Additional experience writing technical protocols, reports, and procedures required.
- Experience in transferring analytical assays into cGMP facility and serving as an SME with external CRO/CDMO.
- Outstanding critical thinking, collaborative mindset and organizational skills, leadership, and attention to details.
- Comfortable in a fast-paced environment.
Desirable
- Prior experience with cell and gene therapy products and processes.
- Good understanding of the interface of analytical development with process development.
- Prior experience of interacting with regulatory agencies via written and teleconference responses.
OTHER REQUIREMENTS
- Potential travel to other office locations for the company and CMOs to assist with tech transfer and troubleshooting activities.
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