"Alerted.org

Job Title: Research Associate

Job Description

We are currently seeking an experienced Research Associate to join the Cell Therapy Process Development team. This role offers an exciting opportunity to lead or support the development and improvement of cell therapy manufacturing processes, contributing to the advancement of cutting-edge therapies. The ideal candidate will possess a strong background in cell therapy or biopharmaceutical development, process optimization, and technology transfer, and be 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 the successful transfer of processes into GMP clinical and commercial manufacturing.

+ Support the 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 (Standard Operating Procedures), and change controls.

+ Identify potential risks in process development and manufacturing, and implement strategies for mitigation, ensuring the successful advancement of cell therapy programs.

Essential Skills

+ Aseptic technique and operation

+ Experience in cleanroom and sterile processing

+ Cell culture and cell therapy expertise

+ Process development knowledge

+ Understanding of GMP standards

+ Proficiency in laboratory work and decontamination procedures

+ Ability to troubleshoot and analyze batch records

+ Knowledge in molecular biology and biopharmaceutical processes

Additional Skills & Qualifications

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

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

+ Strong problem-solving abilities and critical thinking skills.

+ Ability to effectively work in cross-functional teams, meet deadlines, and prioritize multiple projects.

+ Strong 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 is a plus.

Work Environment

The role is based in a lab and office setting, specifically within a cleanroom environment with level 10k and 100k specifications. Responsibilities include maintaining sterile gowning certification and adhering to sterile gowning procedures.

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 30, 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.