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Director, Drug Substance Process Sciences

3 months ago

South San Francisco, United States Allogene Therapeutics Full time

About Allogene:

Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.

About the role:

Allogene Therapeutics is seeking a head of Drug Substance 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 multiple teams developing early and late-stage CAR-T drug substance processes across Allogene’s pipeline.

We encourage applicants who believe they have the skills and drive to succeed at Allogene to apply for this role.

Responsibilities include, but are not limited to:

• Lead Drug Substance 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; 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 control strategies

• Lead the development of robust risk assessments that set the foundation for platform process knowledge, process/raw material characterization. Responsible for process development and process characterization plans utilizing Design of Experiments and Quality by Design methodologies

• Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports, and contribute to Regulatory Filing strategy and content, and responses to Regulatory questions as appropriate

• Demonstrate strong leadership, personal accountability and interpersonal skills, and capability for mentoring junior colleagues (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

• Other duties as assigned

Position Requirements & Experience:

• PhD, MS or BS in Chemical Engineering, Biochemistry, Molecular & Cell Biology, Immunology or the related field

• 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

• 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

• Candidates must be authorized to work in the U.S.

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 to $240,000. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.

As an equal opportunity employer, Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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