FSP Associate Research Scientist: LBA PK & ADA Method Development & Validation Full-time NEW

Job Title

The primary purpose of this position is to contribute to developing, validating, and implementing bioanalytical immunoassays for the measurement of pharmacokinetics (PK), and anti-drug antibodies (ADA) in biological samples to support drug development and regulatory filing.

Job Description

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.

Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.

Essential Functions

• Develops, validates, and implements immunoassays for the analysis of clinical and non-clinical pharmacokinetic or toxicokinetic samples in a GLP-like or GLP environment with some level of guidance

• Ensure assay performance meets regulatory expectations for specificity, sensitivity, precision, accuracy, and robustness.

• Independently troubleshoot and optimize ligand binding PK and ADA assays to ensure robustness and reproducibility.

• Maintain lab inventories and order lab supplies to ensure continuity of bioanalytical activities.

• Utilize Watson LIMS and Electronic Lab Notebooks (ELN) for data processing, documentation, and reporting.

• Ensures that electronic notebooks and other documentations are up to date as per departmental guidelines

• Prepare or contributes to study reports following the departmental policies and procedures.

• Ensures compliance with and maintains required training in BMS and departmental GLP, SOP, safety and other departmental guidelines

• Achieves objectives in a manner consistent with the Core BMS Behaviors

• Prepares and makes scientific presentations at internal and external meetings

Knowledge, Skills, and Abilities

• Strong understanding of GLP-compliant bioanalytical workflows and method development.

• In-depth knowledge of global regulatory expectations (FDA, ICH, EMA) for PK and immunogenicity testing.

• Skilled in data interpretation and familiar with analytical/statistical software.

• Solid foundation in bioanalytical principles including concentration units, calibration curves, and quality controls.

• Proficient in laboratory operations: pipetting, balances, and digital tools.

• Experience with biological sample handling and automated liquid handling systems (e.g., 96-well format).

• Demonstrated expertise in ligand binding assay execution and troubleshooting.

• Excellent written and verbal communication skills with a collaborative and solutions-focused mindset.

• Strong organizational skills and ability to work effectively in a cross-functional team environment.

Education/Experience/ Licenses/Certifications

• Bachelor's degree in relevant life sciences program field AND 6-8 years of relevant experience

Preferred: 4+ years in a CRO or GLP regulated laboratory environment

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.

Working Environment

Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary and/or standing for typical working hours.

Able to lift and move objects up to 25 pounds.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Compensation and Benefits

The salary range estimated for this position based in New Jersey is $90,000.00–$110,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount