Process Development Scientist

Job Title:

Process Development Scientist Cell Therapy (Contract)Job Description This contract Process Development Scientist role supports cell therapy process development activities in a hands-on laboratory setting. You will independently manage the full experimental lifecycle, from designing scientifically robust studies and executing experiments at the bench, through data analysis, interpretation, and preparation of clear technical reports. The position focuses on developing, optimizing, and characterizing cell therapy manufacturing processes, with strong emphasis on experimental design, Design of Experiments (DOE), and rigorous documentation. You will collaborate closely with cross-functional technical teams and contribute to late-stage development activities that support process characterization, validation, and eventual commercialization of cutting-edge cell therapy and mRNA-based technologies. Responsibilities

• Independently design and cell therapy process development experiments with limited day-to-day technical supervision.
• Translate process development objectives and technical questions into appropriate experimental strategies, protocols, and study plans.
• Design of Experiments (DOE) and other structured experimental approaches to evaluate process parameters, interactions, operating ranges, and overall process performance.
• Perform hands-on laboratory studies to support development, optimization, and characterization of cell therapy manufacturing processes, including CAR-T and related modalities.
• Analyze and interpret experimental data, identify meaningful trends, and draw scientifically supported conclusions that inform process development decisions.
• Troubleshoot experimental issues and process performance deviations, and recommend appropriate follow-up studies or process adjustments.
• Prepare clear, technically rigorous study reports that document experimental rationale, methods, results, statistical analyses, conclusions, and recommendations.
• Develop and maintain experimental protocols, batch records, and related technical documentation to support process development and knowledge transfer.
• Present experimental results, data interpretations, and recommendations to Process Development and cross-functional technical teams in a clear and concise manner.
• Maintain complete, accurate, and contemporaneous experimental records to ensure appropriate traceability of data, methods, and conclusions.
• Collaborate with MSAT, Manufacturing, Analytical Development, Quality, and other technical functions to support process development objectives and cross-functional initiatives.
• Support the transfer of process knowledge from development studies into process control strategies, manufacturing instructions, and validation documentation.
• Contribute to late-stage development activities, including process characterization, process validation, PPQ readiness, and commercial process development, as applicable.
• Support risk assessments related to process development, characterization, and technology transfer activities.
• Utilize statistical analysis software, such as JMP or equivalent tools, to support DOE, process characterization, and data-driven decision making. Essential Skills
• BS, MS, or PhD in biological sciences, bioengineering, chemical engineering, biotechnology, or a related scientific or engineering discipline.
• For BS-level candidates, at least 5 years of post-degree industry experience in process development.
• For MS-level candidates, at least 3 years of post-degree industry experience in process development.
• For PhD-level candidates, at least 2 years of post-degree industry experience in process development; postdoctoral experience alone is not sufficient and must be followed by industry experience.
• Direct industry experience in process development, preferably in cell therapy and/or cell culture processes.
• Demonstrated ability to independently design, plan, and process development experiments from concept through completion.
• Experience with statistical analysis software used for DOE and process characterization, such as JMP or equivalent tools.
• Strong hands-on laboratory skills applicable to cell therapy and cell culture process development.
• Proven ability to analyze experimental data and translate results into scientifically defensible conclusions and recommendations.
• Strong technical writing skills, including preparation of experimental protocols, study summaries, and formal technical reports.
• Ability to work independently while clearly communicating experimental plans, results, risks, and recommendations to the broader team.
• Strong collaboration mindset and effective verbal and written communication skills.
• Familiarity with GMP-oriented development practices and working in regulated environments. Additional Skills & Qualifications
• Experience with late-stage process development in the cell therapy space, including autologous cell therapies.
• Experience conducting or supporting process characterization studies for cell therapy or related biologics.
• Experience establishing or evaluating critical process parameters, process operating ranges, and relationships between process parameters and product quality attributes.
• Experience supporting process validation, PPQ readiness, process transfer, or commercialization activities for biologics or cell therapies.
• Familiarity with control strategy development and application of process characterization results to define late-stage processes.
• Experience with CAR-T or other cell therapy modalities.
• Experience with technology transfer activities between development and manufacturing or external partners.
• Experience performing risk assessments related to process development and technology transfer.
• Interest in working with leading-edge technologies such as mRNA and autologous cell therapy.
• Motivation to contribute in a fast-moving environment approaching key clinical or commercial milestones.
• Ability to influence and collaborate within an integrated manufacturing and development organization.

Work Environment This role is fully on site, with a standard schedule of five days per week, typically 8:00 a.m. to 5:00 p.m., with occasional weekend work as needed to support laboratory activities and process development timelines. You will work in a laboratory and development environment focused on cell therapy and mRNA technologies, using equipment and methods aligned with GMP-oriented and regulated development practices. The setting emphasizes hands-on experimental work, close collaboration with Manufacturing, MSAT, Analytical Development, and Quality, and integrated manufacturing capabilities that support end-to-end process development. The culture encourages builders who enjoy working with leading-edge technologies, contributing to key milestones, and learning in a highly collaborative, science-driven environment. Job Type & Location This is a Contract position based out of Frederick, MD. Pay and Benefits The pay range for this position is $60.00 - $75.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/... Visit the Employer site for more details