Research Associate

Job Title: Research Associate Cell Therapy Process Development Job Description This Research Associate role supports the development, characterization, and optimization of cell therapy manufacturing processes within a late clinical-stage biotechnology environment. You will execute hands-on laboratory work across the full upstream process, analyze and communicate experimental data, and contribute to process development documentation in alignment with GMP and regulatory standards. The position offers the opportunity to work on a first-in-class autologous cell therapy candidate aimed at transforming treatment for Chronic Kidney Disease, collaborating closely with cross-functional scientific and quality teams. Responsibilities

- Execute laboratory experiments related to cell therapy process development, including media preparation, cell expansion, harvest, and product formulation.
- Perform cell culture processes in typical laboratory settings, from vial thaw through cell expansion and harvest, using aseptic techniques.
- Analyze experimental data, interpret results, and clearly communicate findings and recommendations to technical stakeholders.
- Support process characterization and optimization activities to improve robustness, scalability, and consistency of upstream biopharmaceutical processes.
- Participate in troubleshooting of process-related issues and contribute to the implementation of new technologies and methodologies in cell therapy manufacturing.
- Collaborate closely with MS&T, Analytical Development, QC, QA, and R&D teams to support development activities and ensure alignment across functions.
- Ensure all process development work complies with GMP, GLP, and applicable regulatory requirements for cell-based therapies.
- Prepare, review, and maintain technical documentation, including process development reports, batch records, standard operating procedures (SOPs), and change controls.
- Identify potential process and manufacturing risks and support the development and execution of corrective actions and risk-mitigation strategies.
- Handle human tissues and primary human cells safely and responsibly in accordance with established procedures and regulatory expectations.
- Manage multiple projects simultaneously, meet deadlines, and effectively prioritize tasks in a fast-paced development environment.
- Contribute to continuous improvement of laboratory practices, documentation standards, and cross-functional communication.
- Perform occasional weekend or off-shift work as required to support time-sensitive experiments or process activities.

Essential Skills

- Bachelors or masters degree in chemical engineering, biomedical engineering, biochemistry, cell biology, biotechnology, or a closely related scientific or engineering field.
- At least 2 years of experience in cell therapy and/or biopharmaceutical upstream process development.
- Hands-on experience executing mammalian cell culture processes, including vial thaw, cell expansion, and harvest in a laboratory setting.
- Proficiency in aseptic techniques and sterile handling of cultures and materials.
- Experience with cell culture and molecular biology techniques relevant to cell therapy and upstream biopharmaceutical development.
- Strong understanding of GMP and GLP principles and regulatory requirements for the development of cell-based therapies.
- Ability to analyze experimental data, apply critical thinking, and draw scientifically sound conclusions.
- Demonstrated ability to work effectively in cross-functional teams and collaborate with stakeholders from MS&T, Analytical Development, QC, QA, and R&D.
- Strong verbal and written communication skills, including the ability to prepare clear technical reports, batch records, SOPs, and other documentation.
- Solid problem-solving skills and the ability to troubleshoot process and assay-related issues.
- Comfort and competence in handling human tissues and primary human cells in a regulated environment.
- Ability to prioritize multiple projects and meet deadlines in a dynamic development setting.

Additional Skills & Qualifications

- Experience specifically in cell therapy process development, including autologous cell-based products, is highly beneficial.
- Experience in biopharmaceutical upstream process development, including media optimization and bioreactor-based expansion, is an advantage.
- Familiarity with assay development and analytical methods supporting process characterization and clinical research.
- Knowledge of risk assessment methodologies and experience supporting corrective and preventive actions (CAPA) for manufacturing and process risks.
- Exposure to working in cleanroom environments with sterile gowning requirements.
- Ability to adapt to evolving technologies and contribute to the implementation of new tools and approaches in process development.
- Strong organizational skills and attention to detail in documentation and experimental execution.
- Motivation to contribute to therapies that aim to preserve kidney function and potentially delay or eliminate the need for dialysis in patients with Chronic Kidney Disease.

Work Environment This role is based in a combined laboratory and office setting, with significant time spent in a controlled cleanroom environment. The cleanrooms are classified at 10K and 100K levels, and you will be responsible for sterile gowning and maintaining certification for sterile gowning procedures. Work is generally scheduled Monday through Friday from 8:00 a.m. to 5:00 p.m., with occasional weekend or off-shift work to support critical experiments or process activities. The environment emphasizes adherence to GMP and GLP standards, careful handling of human tissues and primary human cells, and close collaboration across scientific, technical, and quality functions. You will work with modern cell culture and bioprocessing equipment in a setting focused on developing innovative cell therapy technologies for Chronic Kidney Disease, with a culture that values scientific rigor, patient impact, and cross-functional teamwork.
Job Type & Location
This is a Contract position based out of Winston Salem, NC.
Pay and Benefits
The pay range for this position is $45.00 - $55.00/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/Leave (PTO, Vacation or Sick Leave)
Job Type & Location
This is a Contract position based out of Winston Salem, NC.
Application Deadline
This position is anticipated to close on Nov 27, 2026.
Workplace Type
This is a fully onsite position in Winston Salem,NC. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
adjustment of the job application process or interviewing process due to a disability,
please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
city and county of San Francisco, we will consider for employment qualified applicants
with arrest and conviction records.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

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