Jobs in the United States

25+ jobs

Save this search

Added 5 hours ago
Research Associate, Cell Culture Process Development
Teva Pharmaceuticals
West Chester, PA
We are seeking a Research Associate to join our Cell Culture Process Development team within Biologics CMC in West Chester, PA. This is a hands-on, lab-based role ideal for a motivated…
Added 8 hours ago
Sr. Bioprocess Associate
Astellas Pharma
South San Francisco, CA
The Senior Associate, Technical Development Operations will participate in upstream and downstream areas of AAV development and production within process development and the pilot plant for…
Added 9 hours ago
SC
Clinical Cell Processing Associate
Seattle Children's
Seattle, WA
- $91,010 to $136,514 USD / year
This is an exciting position supporting the development of a new cell processing laboratory. This intermediate position requires significant understanding and some independent application…
Added 10 hours ago
Senior Counsel - Legal
Minaris Advanced Therapies
Philadelphia, PA
…creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments…
Added 1 day ago
D
Supply Chain Operator in Devens, MA
Devens
Devens, MA
- $30.81 to $37.33 USD / hour
Partner with Cell Therapy Manufacturing & Quality to support the readiness for prompt receipt, inspection and start of processing for patient material
Added 1 day ago
UT
Cell Manufacturing Associate I/II (iPSC)
United Therapeutics Corporation
Silver Spring, MD
- $30.05 to $36.06 USD / hour
Join a dynamic and innovative team at the forefront of induced pluripotent stem cell (iPSC) manufacturing. The Cell Manufacturing Associate I/II will play a vital role in the startup and…
Added 1 day ago
Associate, Insights Analyst, US Medical Affairs
Stemline Therapeutics Inc
Remote, United States
Added 1 day ago
AP
Associate Director, Process Development, Cell Therapy
AstraZeneca Pharmaceuticals LP Company
Santa Monica Colorado Avenue, CA
- $138,000 to $207,000 USD / year
The Associate Director, Late-Stage Cell Therapy Process Development, will provide scientific and technical leadership for the development, characterization, and transfer of manufacturing…
Added 1 day ago
A
Associate Director, Process Development, Cell Therapy
AstraZeneca
Santa Monica, CA · Santa Monica
- $138,000 to $207,000 USD / year
The Associate Director, Late-Stage Cell Therapy Process Development, will provide scientific and technical leadership for the development, characterization, and transfer of manufacturing…
Added 1 day ago
Research Associate, Cell Culture Process Development
Teva Pharmaceutical
West Chester
We are seeking a Research Associate to join our Cell Culture Process Development team within Biologics CMC in West Chester, PA. This is a hands-on, lab-based role ideal for a motivated…
Added 1 day ago
Sr. Manager/Assoc Director, Manufacturing Sciences & Technology (MSAT)
Genezen
Lexington, MA
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell…
Added 1 day ago
OB
Associate, Cell Therapy Production, 1st Shift
Orca Bio
Sacramento, CA
- $23 to $28 USD / hour
The Associate, Cell Therapy Production plays a critical role in the production of Orca's cell therapy products, ensuring adherence to strict quality standards, regulatory requirements and…
Added 1 day ago
Sr. Bioprocess Associate
Astellas
South San Francisco, CA
The Senior Associate, Technical Development Operations will participate in upstream and downstream areas of AAV development and production within process development and the pilot plant for…
Added 1 day ago
A
Quality Assurance Specialist I
Actalent
WINSTON SALEM, NC
- $26 to $32 USD / hour
Experience in cell or gene therapy and manufacturing quality.
Added 1 day ago
Team Lead, Value Stream Cryo Operations
Bristol Myers Squibb
Summit, NJ
This role oversees cryopreservation and handling of Cell Therapy products across multiple production areas and shifts, ensuring consistent and compliant execution. Assures individual and…
Added 1 day ago
VC
Senior Technician, Cell Therapy Manufacturing
Vericel Corporation
Burlington, MA
- $21 to $25 USD / hour
Responsible for the execution of process steps to manufacture commercial cell therapy products meeting internal and regulatory requirements.
Added 1 day ago
Core Technician– Cell Therapy
Lonza Houston Inc.
Houston, TX
As a Core Technician - Cell Therapy, you will play a critical role in the manufacturing of clinical and commercial cell therapy products within a highly regulated GMP environment. This…
Added 1 day ago
CT
Manufacturing Associate I
Capricor Therapeutics
San Diego, CA
- $25 to $32 USD / hour
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation…
Added 1 day ago
CT
Associate Director, Cost Accounting
Capricor Therapeutics
United States
- $150,000 to $200,000 USD / year
Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapies for rare diseases. At the forefront of our innovation…
Added 1 day ago
AP
Associate Director, CMC Program Management
AstraZeneca Pharmaceuticals LP Company
Santa Monica Colorado Avenue, CA
- $136,514 to $204,771 USD / year
The Associate Director, Cell Therapy CMC Project Manager is a member of the CMC Project Management – Portfolio Strategy team within Cell Therapy Technical Operations.
Added 1 day ago
AP
Associate Director, Distribution Analytics - Cell Therapy
AstraZeneca Pharmaceuticals LP Company
Gaithersburg, MD
- $155,516.8 to $233,275.2 USD / year
The Associate Director, Distribution Analytics – Cell Therapy will lead the use of data, analytics, and AI-enabled decision support to improve delivery performance across the Cell Therapy…
Added 2 days ago
A
Associate Director, Distribution Analytics - Cell Therapy
AstraZeneca
Gaithersburg, MD · Gaithersburg
- $155,516.8 to $233,275.2 USD / year
The Associate Director, Distribution Analytics – Cell Therapy will lead the use of data, analytics, and AI-enabled decision support to improve delivery performance across the Cell Therapy…
Added 2 days ago
A
Associate Director, CMC Program Management
AstraZeneca
Santa Monica, CA · Santa Monica
- $136,514 to $204,771 USD / year
The Associate Director, Cell Therapy CMC Project Manager is a member of the CMC Project Management – Portfolio Strategy team within Cell Therapy Technical Operations.
Added 2 days ago
A
Associate Director / Director - Biologics Drug Product Development
AbbVie
North Chicago, IL
- $160,500 to $305,000 USD / year
…peptides, neurotoxins etc.) and genetic medicine (AAV, LNPs, Cell…
Added 2 days ago
A
Associate Process Engineer, Cell Therapy Process Development
AstraZeneca
Santa Monica, CA · Santa Monica
- $67,000 to $101,000 USD / year
We are seeking a highly motivated Associate Process Engineer to support late-stage cell therapy process development and characterization activities. In this role, you will play critical…

AstraZeneca

Associate Director, Process Development, Cell Therapy

Santa Monica, CA, United States
Santa Monica, United States

$138,000 to $207,000 USD / year

Apply About employer

Applications open in a new tab.

Job details

Pay: $138,000 to $207,000 USD / year
Apply by: Apr 28, 2027
Posting language: English
Posted: Oct 30, 2026

Original 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 30-Oct-2026 Closing Date 19-Nov-2026Our 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.

Apply About employer

Report this job