Scientist III - Large Molecule

Thermo Fisher Scientific•Greenfield, IN

2d•Onsite

About The Position

The Scientist III conducts advanced analytical testing of pharmaceutical and biopharmaceutical compounds, ensuring laboratory data are accurate and reliable. The role independently performs method validations, method transfers, and testing across a variety of formulations and delivery systems, and designs and executes experiments with minimal supervision. The scientist prepares technical documentation, communicates results and technical issues to clients, supports laboratory quality systems and equipment, and contributes to continuous improvement of laboratory methods and quality standards. This is a fully onsite position at the Greenfield, Indiana laboratory. Applicants from anywhere in the United States are welcome, and relocation assistance is provided. The role follows a standard Monday–Friday work schedule and is based in a laboratory setting where personal protective equipment may be required. Candidates must be legally authorized to work in the United States without sponsorship and must pass a comprehensive background check, including drug screening.

Requirements

Bachelor’s degree, preferably in Life Sciences, or equivalent relevant formal academic or vocational qualification.
Experience comparable to 5+ years; an equivalent combination of appropriate education, training, and directly related experience may be considered.
Solid understanding 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 and client SOPs, ICH guidelines, USP requirements, and FDA guidance.
Ability to use Microsoft Excel and Word to perform tasks.
Proficiency with technical operating systems.
Proven problem-solving and troubleshooting abilities.
Effective oral and written communication skills.
Technical writing skills.
Time management and project management skills.
Ability to work collaboratively with a team.
Ability to train junior staff.
Must be legally authorized to work in the United States without sponsorship.
Must pass a comprehensive background check, including drug screening.

Responsibilities

Independently perform method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds in varied formulations and delivery systems.
Follow applicable methods and protocols for 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 clients and respond to client needs and questions.
Mentor, train, and coordinate laboratory activities of team members.
Assist with troubleshooting instruments and analytical problems.
Support quality systems and new equipment.
Assist in designing method validation or method transfer protocols and establishing project timelines.
Review, interpret, and analyze data for technical quality and compliance with protocols, methods, SOPs, client criteria, and GMP or GLP requirements.
Perform self and peer review of data for accuracy and reporting compliance before submission to QA and issuance to customers.