Description
Process Development Scientist – Cell Therapy
A growing biotechnology organization is seeking a Process Development Scientist to support the advancement of a late-stage cell therapy program. This role is responsible for developing and optimizing scalable, reproducible, and robust manufacturing processes to support clinical and future commercial production of a novel cell-based therapeutic.
The position offers a dynamic and collaborative environment where you'll work cross-functionally to translate lab-scale methods into GMP-compliant manufacturing processes for human therapeutic use.
Key Responsibilities-
Design and execute experiments for process development and optimization, including cell expansion, purification, formulation, and cryopreservation.
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Analyze data, interpret results, and contribute to technical documentation including protocols and study reports.
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Identify and implement process improvements aimed at increasing efficiency, reducing cost, and ensuring product quality.
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Collaborate with internal manufacturing teams and external partners to support technology transfer and GMP production.
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Conduct process risk assessments (e.g., FMEA), and define or validate critical process parameters (CPPs).
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Utilize QbD principles, including Design of Experiments (DoE) and statistical tools, to drive robust process design.
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Remain current on trends and innovations in cell therapy, bioprocessing, and relevant regulatory developments.
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Support internal knowledge sharing and, where appropriate, contribute to scientific communications.
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Degree in Biological Sciences, Bioengineering, Biochemical Engineering, or a related field.
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PhD with 2+ years
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MS with 8+ years
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BS with 12+ years
Strong hands-on experience with cell culture, cell selection, and cell purification techniques.
Proven contributions to process development and successful technology transfer into GMP manufacturing.
Familiarity with analytical methods such as flow cytometry, PCR, ELISA, and cell counting/viability assays.
Strong problem-solving skills and experience troubleshooting cell-based manufacturing challenges.
Clear and concise communication skills, both written and verbal.
Ability to work independently and collaboratively in a fast-paced, cross-functional environment.
Preferred Qualifications-
Experience supporting or preparing regulatory filings (e.g., IND, BLA).
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Knowledge of GMP regulations and regulatory expectations in the cell therapy space.
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Proficiency with data analysis tools such as JMP, Minitab, or equivalent.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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