"Alerted.org

Job Title: Research Associate

Job Description

We are currently seeking an experienced Research Associate to join the Cell Therapy Process Development team. The ideal candidate will possess a strong experience in cell therapy or biopharmaceutical development, process optimization, and technology transfer. In this role, you will lead or support the development and improvement of cell therapy manufacturing processes, contributing to the advancement of cutting-edge therapies. This is a fantastic opportunity for individuals passionate about making an impact in the evolving field of cell therapy.

Responsibilities

+ Design and execute experiments to optimize and improve processes for cell therapy manufacturing, including media preparation, cell expansion and harvest, and product formulation.

+ Analyze experimental data and present results in a clear and actionable manner to stakeholders.

+ Provide technical expertise in the development and implementation of new techniques and technologies.

+ Support troubleshooting and process improvement initiatives.

+ Collaborate closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, and Manufacturing, to ensure successful transfer of processes into GMP clinical and commercial manufacturing.

+ Support characterization and validation of cell therapy processes, ensuring compliance with regulatory guidelines and internal standards.

+ Conduct process performance qualification (PPQ) studies and support clinical trial material production.

+ Ensure all process development activities adhere to GMP and applicable regulatory standards.

+ Support regulatory filings and audits as needed.

+ Prepare and review technical documentation, including process development reports, batch records, SOPs, and change controls.

+ Assist in identifying potential risks in process development and manufacturing, and implement strategies for mitigation.

Essential Skills

+ Aseptic technique and cleanroom operations.

+ Proficiency in sterile processing and cell culture.

+ Experience in process development and cell therapy.

+ Understanding of GMP regulations.

+ Ability to execute and troubleshoot experiments, analyze and present data effectively.

Additional Skills & Qualifications

+ Bachelor's or Master's degree in Cell Biology, Biotechnology, Biochemical Engineering, or related field.

+ Minimum of 2 years' experience in cell therapy and/or biopharmaceutical process development.

+ Strong problem-solving abilities and critical thinking.

+ Excellent verbal and written communication skills, including technical writing.

+ Understanding of GMP, GLP, and regulatory requirements for cell-based therapies.

+ Experience with regulatory submissions and support for inspections.

Work Environment

The role involves working in both lab and office settings. The lab environment includes cleanrooms classified as level 10k and 100k. The candidate will be responsible for sterile gowning and maintaining certification for sterile gowning.

Pay and Benefits

The pay range for this position is $70000.00 - $75000.00/yr.

See company website for details on what is offered for FTE's.

Workplace Type

This is a fully onsite position in Winston Salem,NC.

Application Deadline

This position is anticipated to close on Jul 31, 2025.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email [email protected] (%[email protected]) for other accommodation options.