Immunoassay Method Development and Validation Associate Research Scientist

Thermo Fisher Scientific•Richmond, VA

15d•Onsite

About The Position

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. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Discover Impactful Work: Performs immunoassay method development, validation, and troubleshooting in support of pharmacokinetic, toxicokinetic, pharmacodynamic, and immunogenicity (ADA) sample testing involving novel therapeutics (particularly large-molecule biologics) in the pharmaceutical industry. A day in the Life: Independently performs immunochemistry laboratory experiments and acts as the technical project leader for multiple projects. Designs and executes experiments, reviews and analyzes data, writes reports and other technical documents with minimal supervision. Interacts with clients around technical data, scientific issues, and project status. Responds to client needs. Mentors, trains and coordinates laboratory activities of other team members to achieve project goals within established project timelines. Ensures high-level science, quality and compliance to protocols, methods, SOPs, client criteria, Good Laboratory Practices (GLP), and regulatory guidance. Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 6+ years)
Or Master degree with 4+ years of experience
Or PhD with 2+ years of experience
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.
Solid understanding and knowledge of biology, chemistry, and immunoassay techniques.
Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
Experience working within a Contract Research Organization (CRO)
Ability to utilize Microsoft Excel and Word to perform tasks
Proven problem solving and troubleshooting abilities
Effective oral and written communication skills
Proven ability in technical writing skills
Time management and project management skills
Ability to work in a collaborative work environment with a team
Ability to train junior staff
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 screen.

Nice To Haves

Knowledge of immunoassay platforms such as ECL, ELISA, NULISA, and Gyrolab.
Knowledge of cell therapy, gene therapy, and oligonucleotide bio analysis is a plus.

Responsibilities

Performs immunoassay method development, validation, and troubleshooting in support of pharmacokinetic, toxicokinetic, pharmacodynamic, and immunogenicity (ADA) sample testing involving novel therapeutics (particularly large-molecule biologics) in the pharmaceutical industry.
Independently performs immunochemistry laboratory experiments and acts as the technical project leader for multiple projects.
Designs and executes experiments, reviews and analyzes data, writes reports and other technical documents with minimal supervision.
Interacts with clients around technical data, scientific issues, and project status.
Responds to client needs.
Mentors, trains and coordinates laboratory activities of other team members to achieve project goals within established project timelines.
Ensures high-level science, quality and compliance to protocols, methods, SOPs, client criteria, Good Laboratory Practices (GLP), and regulatory guidance.
Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.