FSP - Scientist III - Large Molecule

Thermo Fisher Scientific•Greenfield, IN

12d•Onsite

About The Position

This is a fully onsite role based at our Greenfield, IN Laboratory. Thermo Fisher Scientific is a global leader in serving science, with a mission to enable customers to make the world healthier, cleaner, and safer. The PPD® Laboratory Services team plays a direct impact on improving patient health through the expertise of scientists, industry thought-leaders, and therapeutic experts. The Scientist III role involves conducting advanced diagnostic tests, ensuring laboratory data accuracy and reliability, mentoring junior scientists, and driving improvements in laboratory methodologies and quality standards. The company offers resources for individual career goals and advances science through research, development, and delivery of life-changing therapies.

Requirements

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).
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
Ability to train junior staff
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.

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.