FSP - Scientist III - Large Molecule

Job Description

This is a fully onsite role based at our Greenfield, IN Laboratory. We welcome applicants from all locations within the US. We welcome applicants from all locations within the US. Please note that relocation assistance will be provided for this position, 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 screening.

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:

As a Scientist III, 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 (Life Sciences degree preferred) 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:

• Solid understanding and knowledge of general chemistry and separation science
• Demonstrated knowledge of multiple applicable techniques such as: HPLC, CE, iCIEF and ELISA
• Full understanding of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance
• Ability to utilize Microsoft Excel and Word to perform tasks
• Proficiency in technical operating systems
• 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
• Proven problem solving and troubleshooting abilities
• Ability to train junior staff