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Process Development Cell Gene Therapy Jobs in California

GeneFab

Senior Process Engineer, MSAT

Alameda, CA · On-site

$117K - $152K/yr

Lead the GMP implementation of internal platform processes for cell and gene therapy modalities, including upstream and downstream unit operations. * Collaborate closely with Process Development to ...

GeneFab

Senior Process Engineer, MSAT

Alameda, CA

$117K - $152K/yr

Lead the GMP implementation of internal platform processes for cell and gene therapy modalities, including upstream and downstream unit operations. * Collaborate closely with Process Development to ...

GeneFab

Senior Process Engineer, MSAT

Alameda, CA

$72 - $89/hr

Lead the GMP implementation of internal platform processes for cell and gene therapy modalities, including upstream and downstream unit operations. * Collaborate closely with Process Development to ...

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All JobsProcess Development Cell Gene Therapy JobsProcess Development Cell Gene Therapy Jobs in California

Process Development Cell Gene Therapy information

What is the difference between Process Development Cell Gene Therapy vs Process Development Associate?

AspectProcess Development Cell Gene TherapyProcess Development Associate
CredentialsBachelor's/Master's in Biotechnology, Molecular Biology, or related fields; experience in cell therapy preferredBachelor's/Master's in Life Sciences; entry-level to mid-level experience in bioprocessing
Work EnvironmentLaboratories focused on cell therapy manufacturing, GMP facilitiesBiotech or pharmaceutical labs, manufacturing support roles
Industry UsagePrimarily in cell and gene therapy companies, biotech firmsBroadly in biotech, pharma, and contract manufacturing organizations

The Process Development Cell Gene Therapy role specializes in developing and optimizing processes for cell-based gene therapies, often requiring specific expertise in cell culture and GMP compliance. In contrast, the Process Development Associate has a broader scope, supporting various bioprocessing activities across different products. Both roles require strong laboratory skills, but the Cell Gene Therapy position emphasizes specialized knowledge in cell therapy manufacturing.

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Process Development Cell Gene Therapy jobs near you
Infographic showing various Process Development Cell Gene Therapy job openings in California as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 11% Part Time, and 2% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution.

Associate Director, Process Development, Cell Therapy

AstraZeneca

Santa Monica, CA • On-site

$138K - $207K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 11 days ago

AstraZeneca rating

8.4

Company rating: 8.4 out of 10

Based on 45 frontline employees who took The Breakroom Quiz

22nd of 86 rated pharmaceutical

Job description

Position Summary
The Associate Director, Late-Stage Cell Therapy Process Development, will provide scientific and technical leadership for the development, characterization, and transfer of manufacturing processes for cell therapy products. This role is responsible for leading a team of scientists and engineers supporting process development activities from clinical development through commercialization, including BLA and global regulatory submissions. The successful candidate will partner cross-functionally with Manufacturing, Quality, Regulatory Affairs, Analytical Development, and CMC teams to ensure robust, compliant, and scalable manufacturing processes.
Key Responsibilities
Technical Leadership
  • Lead the late-stage process development for cell therapies within the Process Engineering function, managing multiple development projects

  • Direct and guide engineers/scientists to deliver high-quality technical documentation for the study design, laboratory execution and report authoring activities

  • Perform risk assessment, data analysis, write technical reports, and present outcome of the studies to cross-functional teams and governance forums

  • Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes

  • Apply AI-enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding

Team Leadership and Management
  • Build, develop, and manage a high-performing team of process development scientists and engineers

  • Establish project priorities, resource allocation, and departmental objectives

  • Foster a collaborative and innovation-driven culture

PPQ & Technology Transfer
  • Support PPQ activities including but not limited to protocol authoring, batch record authoring and planning

  • Support technology transfer of cell therapy processes to internal manufacturing sites including make-a-batch assessments and drafting manufacturing batch records

Lifecycle Management
  • Lead lifecycle management activities for commercial cell therapy products, including process monitoring, continuous improvement, post-approval changes, comparability assessments, and regulatory commitments.

  • Partner with Manufacturing, Quality, Regulatory Affairs, and Technical Operations to implement process improvements, maintain process control, and support ongoing commercial readiness.

Manufacturing Support & Scientific Deviation Management
  • Serve as the Process Development and Engineering SME for manufacturing operations, providing scientific support for deviations, investigations, atypical events, and process-related issues.

  • Lead root cause analyses, impact assessments, and CAPA development using data-driven and risk-based approaches to ensure product quality, compliance, and uninterrupted manufacturing operations.

Regulatory Support
  • Contributes to authoring and reviewing CMC documentation, including cell therapy process descriptions, characterization summaries, PPQ protocols and reports, and control strategy elements.

  • Support preparation of BLA/MAA submissions and responses to regulatory questions related to cell therapy manufacturing.

Cross-Functional Collaboration
  • Work closely with analytical sciences, quality, regulatory, and manufacturing teams to ensure end-to-end process alignment.

  • Represent cell therapy characterization activities in technical meetings, reviews, and governance discussions.

Required Qualifications
  • Ph.D. in Chemical Engineering, Biochemical Engineering, Biological Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline with 6+ years of industry experience; or M.S. with 10+ years of relevant experience; or B.S. with 12+ years of relevant experience.

  • Strong technical expertise in cell therapy process development, GMP operations and late-stage / commercial readiness.

  • Experience with late-stage development, and PPQ for cell therapy processes.

  • Demonstrated proficiency in applying AI tools and digital solutions to data analysis, documentation, and workflow automation.

  • Strong technical writing, data analysis, and problem-solving skills.

Preferred Qualifications
  • Experience with commercial-stage cell therapy or biologics products.

  • Experience supporting PPQ, process validation, and post-approval changes.

  • Familiarity with global regulatory requirements and lifecycle management strategies.

  • Experience designing and executing DOE and multivariate data analysis for cell therapy processes.

Key Competencies
  • Strong team management and talent development experience

  • Excellent cross-functional communication and collaboration.

  • Ability to operate effectively in fast-paced, late-stage development environments.

  • Scientific curiosity, ownership mindset, and willingness to support manufacturing operations.

The annual base pay for this position ranges from $138K to $207K. Our positions offer eligibility for multiple incentives an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.
# Hybrid # Cell Therapy
Date Posted
10-Aug-2026
Closing Date
30-Aug-2026
Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

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About AstraZeneca

Sourced by ZipRecruiter

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. A place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes. Empowered to lead at every level, free to ask questions and take smart risks that write the next chapter for our pipeline and Oncology team. Make a meaningful impact that brings real benefits to society. By applying your knowledge of data, you will help to redefine our industry and ultimately save lives. Work with experts who share a common goal: to accelerate the potential of medicines and the science of tomorrow.

Industry

Pharmaceutical product wholesalers and pharmaceutical and medicine manufacturing

Company size

10,000+ Employees

Headquarters location

Cambridge, Cambridgeshire, GB

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