Scientist III - Large Molecule

Thermo Fisher Scientific•Greenfield, IN

3d•Onsite

About The Position

The Scientist III conducts advanced diagnostic testing and analytical work on pharmaceutical and biopharmaceutical compounds, ensuring accurate and reliable laboratory data. The role independently performs method validations, method transfers, and analytical testing across a variety of formulations and delivery systems, and designs and executes experiments with minimal supervision. The Scientist prepares technical study documentation, communicates data and technical issues to clients, mentors and trains junior scientists, coordinates laboratory activities, and helps troubleshoot instruments and analytical problems. The position also supports quality systems and new equipment, contributes to validation and transfer protocols and project timelines, and reviews data for technical accuracy, quality, and compliance with applicable protocols and standards. This is a fully onsite position based at the Greenfield, Indiana laboratory. Applicants may be located anywhere in the United States, and relocation assistance is provided. The standard schedule is Monday through Friday. Applicants 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 and relevant formal academic or vocational qualification.
Comparable to 5 or more years of relevant experience.
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 in technical operating systems.
Problem-solving and troubleshooting abilities.
Effective oral and written communication skills and proven technical writing skills.
Time-management and project-management skills.
Ability to work collaboratively as part of 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, including drug screening.

Responsibilities

Independently perform method validations, method transfers, and analytical testing of pharmaceutical and biopharmaceutical compounds in various formulations and delivery systems.
Follow applicable methods and protocols and 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 other team members.
Assist with troubleshooting instruments and analytical problems.
Assist with quality systems and new equipment.
Help design method validation or method transfer protocols and establish project timelines.
Review, interpret, and analyze data for technical quality and compliance with protocols, methods, SOPs, client criteria, GMP, and GLP.
Perform self and peer review of data for accuracy and compliance with reporting requirements before submission to QA and issuance to customers.