Senior Scientist - Principal Investigator - LCMS

Senior Scientist

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.

What You'll 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:

• 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).

Knowledge, Skills and Abilities:

• Principal Investigator exp is a MUST HAVE. Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
• Solid understanding and knowledge of general chemistry and separation science. LCMS is a BIG PLUS
• 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

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…