FSP Sr. Scientist Neutralizing Antibody Assays (NAb)

Work Schedule

Environmental Conditions

Job Description

Join us as Senior Scientist!

At Thermo Fisher Scientific youll 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.

What Youll Do:

• 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.

Education and Experience:

• Bachelors 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.

Knowledge Skills and Abilities:

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

Working Conditions and Environment:

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants radiation toxic materials and hazardous waste.
• Personal protective equipment is required such as protective eyewear garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.

Physical Requirements:

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast simple repeated movements of the fingers hands and wrists to operate lab equipment.
• Occasional mobility needed.
• Occasional crouching stooping with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.

Why Join Us
When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experience and where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthrough.

Compensation and Benefits

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

For more information on our benefits please visit: Experience:

Senior IC