Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category:People Leader
All Job Posting Locations:Malvern, Pennsylvania, United States of America
Job Description:We are searching for the best talent for an
Associate Director, Product Characterization - In Vivo CAR-T to be in Malvern, PA.
Purpose: The Therapeutics Development and Supply, Analytical Development (AD) organization is seeking a highly skilled and dedicated Associate Director of Analytical Development to join our Cell and Gene Therapy Analytical Development leadership team. The individual will work with cross-functional teams to develop comprehensive, phase-appropriate product characterization approaches for in vivo CAR-T that support product understanding, development decisions, and health authority expectations. This role is critical in driving the development and execution of innovative analytical comparability and product characterization strategies, ensuring the successful advancement of our innovative therapies through global regulatory filings.
You will be responsible for:- Lead and manage a team of scientists focused on analytical comparability and product characterization for In Vivo and ex vivo cell therapy, ensuring robust strategy development in alignment with statistical rigor and global health authority expectations
- Oversee the ideation, development, and implementation of advanced analytical methodologies associated with comparability and deep characterization of cell and gene therapy products.
- Set the overarching scientific and technical strategy for in vivo CAR-T lentivector characterization, shaping cross-functional product understanding and control strategy to support portfolio decisions, regulatory readiness, and advancement of next-generation cell and gene therapy platforms.
- Lead development of phase-appropriate CQA and control strategy frameworks for targeted lentiviral vectors, linking process parameters, product quality attributes, mechanism of action, transduction efficiency, biodistribution, insertional risk, and functional CAR-T cell generation to support development decisions.
- Apply deep immunology and lentivector mechanism expertise to guide product characterization strategy, including understanding of immune cell targeting, in vivo transduction biology, vector-mediated CAR expression, and functional generation of therapeutic CAR-T cells.
- Drive strategic scientific communication for internal governance, senior leadership, external partners, and regulatory interactions, ensuring complex technical data are translated into clear recommendations and development decisions.
- Collaborate cross-functionally with Process Development, Translational, Discovery, quality assurance, regulatory affairs, and manufacturing teams to integrate analytical strategies within the broader development processes.
Qualifications:- Ph.D. in Immunology, Biochemistry, Virology, Molecular Biology, Bioengineering, or Analytical Chemistry, Pharmaceutical Sciences, or a related field.
- A minimum of 6-8+ years of relevant industry experience in analytical development for advanced therapy modalities, including demonstrated scientific leadership, cross-functional influence, and strategy ownership in cell and gene therapy development.
- Deep scientific expertise in immunology and lentivector mechanisms, with strong understanding of immune cell biology, in vivo gene delivery, vector targeting, transduction, CAR expression, and functional T cell biology as applied to in vivo CAR-T therapeutic development.
- In-depth knowledge of regulatory requirements and industry best practices related to analytical comparability and product characterization.
- Strong leadership, communication, and interpersonal skills with a proven ability to influence stakeholders and drive collaborative efforts.
Required Skills: Preferred Skills:Analytical Reasoning, Biochemistry, Chemistry, Manufacturing, and Control (CMC), Clinical Research and Regulations, Clinical Trial Designs, Developing Others, Drug Discovery Development, Inclusive Leadership, Leadership, Molecular Diagnostics, Pharmacovigilance, Process Improvements, Productivity Planning, Program Management, Quality Assurance (QA), Scientific Research, Tactical Planning, Team Management, Troubleshooting
