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Cell Therapy Process Development Jobs in North Carolina

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Cell Therapy Process Development information

What is cell therapy process development?

Cell Therapy Process Development refers to the design, optimization, and scaling up of manufacturing processes for cell-based therapies, such as CAR-T cells or stem cell products. Professionals in this field work on translating laboratory research into reproducible, efficient, and safe production methods that meet regulatory standards. This involves working with cell culture techniques, bioreactors, quality control, and process validation to ensure that therapies can be produced consistently for clinical and commercial use. The goal is to develop robust processes that deliver safe and effective cell therapies to patients.

What are the key skills and qualifications needed to thrive as a cell therapy process development professional?

To thrive in Cell Therapy Process Development, you need a solid background in cell biology, biotechnology, or a related field, often supported by a relevant degree and experience with cell culture techniques. Familiarity with bioprocessing equipment, Good Manufacturing Practice (GMP) regulations, and analytical tools such as flow cytometry and PCR is typically required. Strong problem-solving skills, attention to detail, and effective teamwork enhance performance in this collaborative and innovative environment. These competencies ensure the safe and efficient development of cell therapies, meeting rigorous quality standards and advancing clinical applications.

What are some typical challenges faced by professionals in cell therapy process development, and how are they addressed?

Professionals in Cell Therapy Process Development often encounter challenges such as scaling up production processes from laboratory to clinical or commercial scale while maintaining product quality and consistency. Additional hurdles include adhering to strict regulatory requirements and managing complex collaborations across cross-functional teams, like quality assurance, regulatory affairs, and manufacturing. These challenges are typically addressed through rigorous process optimization, thorough documentation, and ongoing communication with stakeholders to ensure that all aspects of the process meet industry standards and regulatory expectations.

What is the difference between Cell Therapy Process Development vs Cell Therapy Manufacturing Specialist?

AspectCell Therapy Process DevelopmentCell Therapy Manufacturing Specialist
CredentialsTypically requires a degree in biology, biochemistry, or biomedical engineering; certifications in GMP or cell therapy are commonSimilar credentials; often holds degrees in related fields and GMP certifications
Work EnvironmentResearch labs, development facilities, early-stage process optimizationManufacturing plants, production floors, quality control labs
Industry UsageFocuses on developing and optimizing cell therapy processesInvolved in large-scale production and process execution

Cell Therapy Process Development professionals focus on designing and refining cell therapy procedures, while Cell Therapy Manufacturing Specialists handle the production and quality assurance in manufacturing settings. Both roles require similar educational backgrounds and certifications but differ mainly in their work environment and specific responsibilities.

What are popular job titles related to Cell Therapy Process Development jobs in North Carolina?

For Cell Therapy Process Development jobs in North Carolina, the most frequently searched job titles are:

What job categories do people searching Cell Therapy Process Development jobs in North Carolina look for?

The top searched job categories for Cell Therapy Process Development jobs in North Carolina are:

What cities in North Carolina are hiring for Cell Therapy Process Development jobs?

Cities in North Carolina with the most Cell Therapy Process Development job openings:

Cell Therapy Process Development jobs near you
Infographic showing various Cell Therapy Process Development job openings in North Carolina as of August 2026, with employment types broken down into 1% As Needed, 79% Full Time, 11% Part Time, 7% Temporary, and 2% Contract. Highlights an 89% Physical, 3% Hybrid, and 8% Remote job distribution.

Associate Director, Process Analytics, Analytical Development Gene Therapy

Durham, NC • Hybrid

Novartis
Pharmaceutical and Medicine Manufacturing • 10K+ employees

7.8

Company rating: 7.8 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

49th of 86 rated pharmaceutical

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Learn more about Novartisexternal

Full-time

Retirement

Re-posted 13 days ago

Job description

Job Description Summary

What if your scientific leadership could help accelerate the next generation of gene therapies for patients with serious and life-changing diseases? As Associate Director, Process Analytics, Analytical Development Gene Therapy, you will play a pivotal role in shaping the analytical strategy that supports innovative cell and gene therapy programmes from development through technology transfer. Working at the intersection of science, strategy and leadership, you will lead talented teams, provide technical oversight across complex development activities, and influence critical programme decisions. This is an exciting opportunity to join a growing Gene Therapy Analytical Development organisation and help advance cutting-edge therapies that have the potential to transform patients' lives.
Location: Durham, US #LI-Hybrid


Job Description

Responsibilities:

  • Lead analytical strategy and testing activities supporting cell and gene therapy process developmentprogrammes.

  • Provide technical oversight for process development,optimisation,characterisationand technology transfer activities.

  • Serve on the Gene Therapy Analytical Development Leadership Team, shapingorganisationalgoals and strategy.

  • Lead,coachand develop scientists to deliver high-quality results and achieveprogrammeobjectives.

  • Partner with cross-functional stakeholders across development, manufacturing,qualityand regulatory functions.

  • Drive technical assessments and influence keyprogrammedecisions through scientificexpertiseand insight.

  • Author, review and approve analytical documentation, ensuring accuracy,qualityand compliance.

  • Champion laboratory innovation, supporting technology evaluation,adoptionand laboratory expansion initiatives.

  • Present technical findings, projectupdatesand strategic recommendations to senior leaders and stakeholders.

  • Support regulatory submissions, health authorityinteractionsand responses to technical information requests.

Essential for the role:

  • PhD in Biology, Chemistry, Biochemistry, Biotechnology, BiomedicalEngineeringor a related scientific discipline.

  • Significant experiencesupporting analytical development within the cell and gene therapy field.

  • Strongexpertisein analytical methods used for cell and gene therapy process development.

  • Provenpeopleleadership or matrix leadership experience within a scientific environment.

  • Deep understanding of scientific principles underpinning analytical development andbiologicsdevelopment.

  • Strong knowledge of phase-appropriate compliance expectations within regulated development environments.

  • Excellent communication and presentation skills, with the ability to influence cross-functional stakeholders.

  • Demonstrated problem-solving, decision-makingand technical leadership skills in complex developmentprogrammes.

Desirable for the role:

  • Experience authoring laboratory Standard Operating Procedures and technical instructions.

  • Experience supporting regulatory submissions, health authorityinteractionsand technical information requests.

Benefits & Rewards:

At Novartis, we're committed to reimagining medicine together - and rewarding the people who make it happen.

Expected Annual Base Salary Range for role: 145,600.00 to 270,400.00 USD

The base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.

The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.

In addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters. Long-term equity awards granted at group level may also be part of your package. Further details will be provided during the application process.

Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverse, equitable and inclusive environment that treats all employees with dignity and respect, as outlined in our Code of Ethics.

Read our brochure to learn more about our global total rewards offering: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Note: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.


EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.


Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.


Salary Range

$145,600.00 - $270,400.00


Skills Desired

Analytical Chemistry, Biotechnology, Business Acumen, Chemical Analysis, Chemical Laboratory, Chemical Synthesis, Chemistry, Collaboration, Data Analysis, Deep Learning, Drug Development, Employee Development, Innovation, Machine Learning (ML), Medicinal Chemistry, Molecular Biology, Organic Chemistry, Pharmaceutical Industry, Project Team Management, Results-Oriented, Science, Strategic Planning, Strategic Thinking, Team Management

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