Director, Attribute Sciences

Allogene Therapeutics•South San Francisco, CA

10d•Onsite

About The Position

Allogene Therapeutics is seeking a highly motivated technical leader to join Allogene’s Process and Product Development organization to lead product characterization strategy in support of successful BLA filing. This individual will work in close collaboration with key stakeholders, including Research and Translational Sciences, Quality, and Regulatory Affairs to align and execute CAR T cell characterization and process-to-product understanding in accordance to ICH and regulatory guidelines. This position is based from our headquarters in South San Francisco.

Requirements

PhD, MS, or BS in Immunology/ cell and molecular biology or equivalent with at least 10 years relevant experience in the development of cell therapy analytical methods; T cell phenotype/ genotype and functional characterization preferred
Proven ability to successfully lead teams in elucidating complex cell therapy product understanding
Demonstrated technical and strategic leadership and problem-solving skills
Strong interpersonal skills with the ability to establish, motivate and lead highly-functioning teams, and influence across organizational boundaries
Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines
Strong verbal and written communication skills are essential in this fast-moving and collaborative work environment.
Candidates must be authorized to work in the U.S.

Nice To Haves

Demonstrated understanding of ICH and global regulatory agency guidance and direct experience contributing to regulatory filing and BLA authorship of product characterization and related sections
Prior industry experience in cell therapy analytical development and characterization

Responsibilities

Responsible for developing strategy and authoring of product characterization sections of regulatory filings from IND to BLA for cell therapy products
Contribute to/ drive relevant and impactful innovation programs to enhance CAR T cell characterization and process-to-product understanding to align with regulatory expectations
Collaborate with Process Science leads in process characterization for identification and/or evaluation of Critical Quality Attributes and to support building phase appropriate control strategies
Responsible for analytical characterization of gene editing (e.g. TALEN and CRISPR) and gene insertion (viral and non-viral) technologies for impacts on cell therapy products, such as on/off-target editing
Demonstrate strong leadership, personal accountability and interpersonal skills, and capability for mentoring junior colleagues (direct reports and others), and uphold safe, high-quality lab practices
Build strong relationships and collaborate effectively to ensure seamless interactions with internal and external partners and stakeholders
Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports, contribute to Regulatory Filing strategy and content, and responses to Regulatory questions as appropriate
Maintain awareness of current state of the field (literature, regulatory expectations and competitive surveillance)