FSP -- Sr. Scientist -- Neutralizing Antibody Assays (NAb)

Thermo Fisher Scientific • Lawrenceville, NJ

1d • Onsite

About The Position

Join us as Senior Scientist! 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. As a Senior Scientist, your role will be to conduct advanced diagnostic tests, ensure the highest accuracy and reliability of laboratory data, mentor junior scientists, and drive continuous improvements in laboratory methodologies and quality standards.

Requirements

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience to provide the knowledge, skills, and abilities to perform the job (comparable to 5+ years). 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.
• Hands-on experience with cell culture techniques, including cell passaging, sterile technique, and immunoassays
• Strong foundational knowledge of general chemistry and separation science
• Proficiency in Watson LIMS and Electronic Laboratory Notebooks (ELN)
• Practical experience using plate readers, automated cell counters, pipettes, and working within a biosafety cabinet/hood
• Thorough understanding of Good Laboratory Practice (GLP) and experience working in a regulated laboratory environment
• Comprehensive knowledge of laboratory compliance requirements, including PPD and client SOPs, ICH guidelines, USP requirements, and FDA regulations
• Demonstrated experience with laboratory documentation, including data recording, protocol execution, deviations, investigations, and report writing in compliance with GLP standards
• Proficient in Microsoft Excel and Word for data analysis, documentation, and reporting
• Comfortable working with technical operating systems and laboratory software
• Demonstrated problem-solving and troubleshooting capabilities
• Strong oral and written communication skills, including technical and regulatory documentation
• Effective time management and project management skills with the ability to manage multiple priorities
• Proven ability to work collaboratively in a team-oriented environment
• Experience training and mentoring junior staff

Nice To Haves

• Experience with pharmacokinetic (PK) and anti-drug antibody (ADA) assays is desirable

Responsibilities

• Independently perform method validations, method transfers and analytical testing of pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems.
• Understand and conform to methods and protocols applicable to assigned tasks.
• Design and execute experiments with minimal supervision.
• Prepare study protocols, project status reports, final study reports and other project-related technical documents.
• Communicate data and technical issues to the client and respond to client needs and questions.
• Mentor, train and coordinate laboratory activities of other team members and assist in troubleshooting instruments and analytical problems.
• Assist with quality systems and new equipment.
• Assist in designing method validation or method transfer protocols and establish project timelines.
• Review, interpret, and analyze data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
• Perform self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees