Senior Director, Process Sciences

About the role

Allogene Therapeutics is seeking a Senior Director, Head of Process Sciences group within the Process and Product Development organization. This role will be responsible for driving innovation, developing new cell therapy technologies, and implementing robust CAR-T processes to advance Allogene’s core technologies in our GMP manufacturing facilities. This individual will be responsible for leading Drug Substance and Drug Product teams developing early and late-stage CAR-T processes across Allogene’s pipeline. This role is onsite in our HQ in South San Francisco, CA and reports directly to the Executive Director, Process and Product Development.

Responsibilities

• Lead Cell Starting Material, Drug Substance, and Drug Product process development teams responsible for early and late-stage manufacturing processes
• Build strong relationships and collaborate effectively to ensure seamless interactions with internal and external partners and stakeholders; Lead and contribute to Project Technical Teams as appropriate
• Apply Quality by Design principles to develop a deep understanding of process-to-product relationships to define and enable robust, integrated BLA enabling control strategies
• Lead the development of robust risk assessments that set the foundation for platform process knowledge and process/raw material characterization. Responsible for process development and process characterization plans utilizing Design of Experiments and Quality by Design methodologies
• Ensure high-quality across teams, timely documentation in electronic laboratory notebooks and Technical Reports
• Contribute to Regulatory Filing strategy and content, and responses to Regulatory questions as appropriate (IND through BLA)
• Demonstrate strong leadership, personal accountability and interpersonal skills, and capability for mentoring junior and senior colleagues (direct reports, their direct reports and others), and establish safe, high-quality lab practices
• Maintain awareness of current state of the field (literature, Regulatory expectations and competitive surveillance) and collaborate on/ author external publications and present at external conferences as appropriate

Position Requirements & Experience

• PhD, MS or BS in Chemical Engineering, Biochemistry, Molecular & Cell Biology, Immunology or the related field with 12+ years of relevant experience required with at least 5 years in a management role leading a team
• A demonstrated foundational understanding of mammalian or primary cell culture, biochemistry, molecular & cell biology and immunology (required for enhanced product & process understanding)
• Experience with development and manufacture of viral vectors and gene editing technologies desired
• Proven ability to successfully manage multiple process development functions in complex biological processes is expected, including significant experience with process characterization/ validation/ commercialization; Cell and gene therapy experience a plus
• Demonstrated technical and strategic leadership and problem-solving skills
• Experience in cell therapy manufacturing processes and technology transfer
• Ability to work in a fast-paced, dynamic, startup environment
• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously
• Experienced leader of scientific teams
• Experienced project management/leadership 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
• Ability to work independently and as part of a team