Senior Manager, QC Raw Materials

About Us:

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.

About the role:

We are seeking a highly motivated Senior Manager, QC Raw Materials to join our team. You will work within the Quality team in supporting our efforts in an exciting area of cancer immunotherapy. The successful candidate will oversee the raw materials management program including inspection, sampling and testing programs at Allogene and oversight of RM testing at external laboratories. The position will report to the Director, Quality Control and requires onsite presence 5 days a week at our manufacturing facility in Newark, CA.

Responsibilities include, but are not limited to:

• Responsible for the overall strategy, direction, oversight, planning, implementation and day to day operation of the raw material program and ensuring the compliant inspection, sampling and testing of raw materials within agreed upon turn-around time (TAT)
• In collaboration with QA and Process and Analytical Development, support the Allogene raw materials program to create phase appropriate raw materials specifications and qualify vendors
• Support vendor qualification program, ensuring project timelines and budget are met
• Provides technical guidance to external contract laboratories related to RM testing and investigation as needed
• Hire, train, and manage QC analyst(s) responsible for raw materials inspection
• Represent QC on SAP team to build raw materials related metadata
• Oversee the raw materials sample management and testing in LIMS system
• Author submission documents related to RM specifications and testing.
• Interact with internal auditors/external inspectors as needed
• Support activities related to raw materials vendor changes and represent QC on RM review board.
• Collaborate cross functionally and builds relationships with internal stakeholders within QC, QA, Regulatory Affairs, Development, Manufacturing and with external customers to meet target milestones
• Other duties as assigned

Position Requirements & Experience:

• Bachelor’s degree in chemistry, biochemistry or related field (advanced degree preferred) with at least 6 years of relevant experience in the biotechnology or pharmaceutical industry
• Experience of managing external contract laboratories and vendors
• Strong understanding of GMP requirements and QC systems as well as regulations pertaining to raw materials management
• Strong technical knowledge and writing skills to draft protocols, reports, and investigations
• Experience using LIMS and/or SAP systems to manage sampling, testing and release of raw materials
• Experience interacting with regulatory agencies, supporting inspections as well as experience with regulatory filings
• Experience in managing and investigating deviations
• 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
• Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• 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 $150,000 to $180,000 per year. 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, designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

#LI-EL #LI-Onsite