Job Description
About the role: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.
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)
Position Requirements & Experience:- 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.
Preferred Qualifications:- 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
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $200,000 - $230,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
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