Research Scientist - Large Molecule

Thermo Fisher Scientific•Indianapolis, IN

21h•Onsite

About The Position

This is a fully onsite role based at our GMP Laboratory in Greenfield, IN. We welcome applicants from all locations within the U.S. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. 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. As a Research Scientist, you will conduct and provide technical guidance on scientific method development and validation projects and/or other specialty technologies studies OR perform troubleshooting for own and others instruments, methods, procedures, and in writing protocols and reports. You will design and execute method development/validation and/or extractable/leachable studies independently and interpret and review analytical data for self and others OR design and execute multiple stability and inhalation procedures as well as assists others in performing routine maintenance and troubleshooting on multiple instruments (HPLC, GC, UPLC, ICP-MS, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.), methods and procedures. You will routinely act as the technical project leader for multiple projects, provide updates, review and evaluate data, write reports and protocols.

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ 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.
Intermediate knowledge of general chemistry and separation science
Demonstrated knowledge of multiple applicable techniques such as: HPLC, ELISA, GC, MS, Dissolution Testing, Inhalation Testing, Biopharmaceutical Testing, Karl Fischer, UV-Vis, FT-IR, TOC
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
Full knowledge of technical operating systems
Ability to independently optimize analytical methods
Ability to independently perform root cause analysis for method investigations
Proven technical writing skills
Proven problem solving and troubleshooting abilities
Effective written and oral communication skills as well as presentation skills
Time management and project management skills
Ability to mentor others on technical operating systems
Ability to independently review and understand project proposals/plans
Ability to work in a collaborative work environment with a team
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 performs analytical method development/optimization/validation, and/or other specialty technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds or equivalent levels of expertise and experience in mass spectrometetry or other related areas such as structural elucidation or extractable leachable testing in a variety of formulations and/or delivery systems.
Designs and executes experiments independently for self and others.
Writes, reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents.
Leads analytical (procedural and instrumental) troubleshooting sessions.
Assists business development group in technical sales and marketing, and presents posters at technical conferences.
Leads in preparation and implementation of SOPs and quality systems, as well as developing innovative technology and in evaluating and implementing new capabilities.
Reviews, interprets, and analyzes data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP).
Performs self and peer review of the data for accuracy and compliance with reporting requirements prior to submission to QA and issuance to customers.