Sr. Scientist – Cell Based Assay Development

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

FSP – Sr. Scientist – Cell Based Assay Development

Shift: Full-Time; Monday – Friday; 8am-5pm EST

ONSITE:

This is a fully onsite role based at our customer’s site in (Cranbury, NJ). We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.  

Must be legally authorized to work in the United States without sponsorship. 

Must be able to pass a comprehensive background check, which includes a drug screening. 

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.

Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.

Key responsibilities:

• Support assay development, optimization, validation, and execution.
• Conduct quantitative bioanalysis of samples generated from in vivo, ex vivo, and in vitro experiments.
• Support developing and qualifying bioassays for characterization, release, and stability testing of engineered CD34+ hematopoietic stem cells.
• Support daily operations by maintaining and qualifying controls and critical reagents.
• Be responsible for the execution and data review of analytical assays.
• Maintain accurate and detailed laboratory notebooks in a timely fashion and prepare technical reports, summaries, and protocols.
• Collaborate with others to handle day to day operation of the laboratory to ensure smooth operation
• Support bioassay development for early and late-stage development programs, development of fit-for-purpose biological characterization assays.
• Review and assist with authoring documents including development reports, SOPs, assay transfer protocols/reports.

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• Sr. Scientist: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 4+ years’)
• OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’)
• OR PhD

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• MS in relevant life sciences discipline or BS with 6 years of relevant experience, or equivalent combination of education and experience.
• Previous industry or academic experience in cell therapy research and development is preferred.
• Experience in cell therapy product characterization, method bridging, comparability, and control strategy experience is a plus.
• Technical experience in multi-parameter flow cytometry, molecular biology (primer/probe design, ddPCR, RT-PCR), and/or cell-based potency methodologies will be of value.
• An understanding of the fundamentals of ICH and other industry guidelines supporting method development,