Senior Director, Head of Product Sciences
Affini-T
- Watertown, MA
- Permanent
- Full-time
Affini-T Therapeutics is a biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of gene editing and synthetic biology, we aim to enhance T-cell fitness to overcome the immunosuppressive tumor microenvironment, with the goal of inducing long-term responses in patients with solid tumors.Affini-T Therapeutics is announcing a Senior Director, Head of Product Sciences opportunity at our headquarters in Watertown, MA.Position Summary
The Head of Product Sciences role is situated within the larger CMC organization responsible for process development, analytical development, technology transfers, manufacturing, and supply of our drug product TCR T cell candidates, drug substance and critical intermediates such as gene editing reagents, viral (LVV) and non-viral vectors.The Head of Product Sciences is a key leader at Affini-T Therapeutics who will have oversight of an eight person team, as well as the overall CMC Analytical Development effort and will partner with multiple interfaces (CMC functions, Regulatory, Quality, Discovery, Translational Medicine, Program Teams, and Contract Laboratories) to define the analytical control strategies for our cell therapies. They will drive scientific, technical, and executional excellence in the development and technology transfer of assays (immuno-, molecular, cytometry, and cell-based assays) used in the characterization and quality control of our TCR T cell therapy products and intermediates.This is a unique opportunity to shape the analytical control strategy and roadmap to product licensure in a rapidly growing biotechnology company with a highly people- and patient-centric, science-driven culture. The ideal candidate will have extensive experience leading large teams in the robust interrogation of the structure-function of complex biologics, cell, or gene therapies, and embraces the privilege of leadership with humility, grace, and an indomitable will to succeed.Essential Duties and Responsibilities
The major tasks for this position are as follows:
- Manage, grow, and mature the Analytical Development function and balance and prioritize resource allocation based on program priorities.
- Develop and provides strategic vision and tactical direction across multiple teams, laboratories (incl. contractors) and analytical techniques to develop a comprehensive understanding of our gene-modified cell therapy products from preclinical development through commercial launch.
- Lead and manage teams focused on analytical method design, development, technology transfer, qualification, and validation.
- Work with other functions (e.g., Process Sciences, MSAT, Translational Medicine) to establish appropriate analytical supports for process and product characterization.
- Maintain high autonomy and science-driven decision making throughout the Product Sciences teams within the context of a matrixed development organization and through processes fostering frictionless communication of development progresses and risks.
- Communicate very effectively to leadership team, peers, reporting lines and key partners and stakeholders across the organization.
- Drive excellence in the execution and continuous improvement of appropriate laboratory controls for sample management, data integrity, analytical instrumentation, and reagent performance.
- Author, Review and/or approve IND, IMPD, BLA and MAA sections and participate in interactions with regulatory bodies throughout the product development lifecycle.
- Maintain awareness of the current state of the field (literature, regulatory expectations, and competitive surveillance), and contribute to the broader cell and gene therapy industry and academic ecosystem through publications and conference presentations.
- Coaching and Mentorship of a high-performing team of Directors, Associate Directors, Principal Scientists, Scientists, and Research Associates in the fundamentals of rigorous and sound analytical development and product characterization, including creating opportunities for continuous professional development.
Education and Experience:
- PhD in chemical or biological sciences with 12+ years of biopharmaceutical experience, or equivalent.
- Experience in all stages of analytical development and product characterization from preclinical through product licensure, including intra- and inter-company technology transfers, CRO/CDMO management, and the evaluation of novel analytical technologies.
- Experience across a broad range of analytical cellular, genomic, proteomic, metabolomic, and biomolecular analytical techniques (incl. compendial methods, FACS, qPCR and ddPCR, NGS, cell-based bioassays, RNASeq, HPLC, and mass spectrometry)
- Experience with the management and operations of BSL2 laboratories.
- Expert proficiency deploying ICH principles for analytical method development, qualification, and validation.
- Expert proficiency in the statistical design of experiment and large dataset analytics
- Expert proficiency streamlining the generation, review, and approval of test methods, development reports, qualification reports, stability protocols, and product characterization studies in support of technology transfers and IND/IMPD/BLA/MAA filings.
- Fluency with global regulatory guidelines and requirements for advanced therapy medicinal products.
- Experience with analytical development for cell and gene therapies is a strong plus.
- Experience with the evaluation of exploratory biomarkers is a strong plus.
- Ability to explore creative approaches to accelerate analytical method development, evaluation of exploratory biomarkers, technology transfer, and comparability assessments.
- Ability to thoughtfully balance the three pillars of Quality, Speed, and Cost for effective product development.
- Outstanding leadership and management skills to inspire, coach, mentor, and grow a strong organization.
- Instinctive personal alignment with Affini-T’s values, mission, and vision.