Senior Qualification Validation Specialist

Job Description

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:

The Senior Qualification / Validation Specialist develops, implements, and manages equipment qualification and validation strategies and activities supporting Allogene Therapeutics’ cGMP Manufacturing area and QC laboratories. This role ensures that programs are delivered on time, on budget, and at the required level of quality, and that they comply with regulatory agency requirements and applicable SOPs. This is a 5 day a week onsite role in Newark, California.

Responsibilities include, but are not limited to:

• Support the commissioning, qualification, and validation lifecycle (URS, RA, IQ, OQ, PQ, and final reports) and associated execution activities for: Manufacturing equipment: CliniMACS Prodigy, Sepax C-Pro, Controlled temperature units, cold rooms, Automated fillers, isolators, etc.
• QC equipment: NC-200, FACSLyric, QuantStudio, ddPCR, Endoscan-V, BACT, SoftMaxPro, etc.
• Partner with Production and MSAT to define requirement updates and requalification activities that support process validation.
• Lead the resolution of complex validation and technical challenges.
• Partner with Quality to translate feedback (e.g., regulatory inspection findings, changes in regulations) into a common approach for qualification and validation activities.
• Maintain a high-level overview of the state of equipment qualification and validation across the business and establish equipment and project prioritization.
• Keep all activities inspection-ready ahead of internal and external audits, with the goal of no critical observations related to validation. • Ensure validation activities comply with current Allogene Therapeutics requirements and cGMP, including managing associated deviations and overseeing pre-validation and validation resulting from major or complex changes. • Serve as Systems Administrator for equipment and systems (LabVantage, MODAEM). CONFIDENTIAL
• Support periodic review of equipment and systems.
• Benchmark against external industry standards to drive best-in-class practices and share knowledge across Allogene Therapeutics.

Qualifications:

• Bachelor’s degree required combined with 8+ years of experience equipment Validation, manufacturing, manufacturing science and technology (MSAT), or Quality Validation
• Thorough understanding of qualification and validation requirements per ICH, GAMP 5, and 21 CFR Part 11
• Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities
• Strong Technical writing skills to author protocols and reports
• Expertise in reviewing and writing technical reports
• Excellent communication and technical writing skills
• Proficiency with Microsoft Word, Excel, and PowerPoint Physical Demands The physical demands described here are representative of those required to perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.
• Regularly required to use hands to finger, handle, or feel objects, tools, or controls; reach with hands and arms; and stoop, kneel, or crouch
• Specific vision requirements include close vision and the ability to adjust focus
• Gown in and enter classified areas (cleanroom environments)
• 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 $ 145,000.00 to $160,000.00 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.

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