Research Scientist / Sr Research Scientist - Large Molecule

Thermo Fisher Scientific•Greenfield, IN

2d•Onsite

About The Position

As a Research Scientist or Sr Research Scientist, you will oversee complex analytical development and/or specialty technologies projects to create new analytical methods, enhance existing methods, and transfer client-provided methods using multiple instrumentation techniques (CE, ELISA, HPLC, LC/MS, GC/MS etc.) and multiple detection techniques (UV, FL, CAD, ELSD, IC etc.). Provide technical and regulatory consulting to internal groups and clients about their programs. Provide technical guidance and mentorship to senior staff members in performing laboratory activities. Routinely act as the technical project leader for multiple projects, interacts with clients to provide technical project updates, reviews and evaluates data, writes reports and protocols.

Requirements

Large Molecule / Biologics Testing Background MUST HAVE
Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
RS: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8-10+ years’) OR Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 6-8+ years’) OR PhD and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 4-6+ years’)
Solid understanding and 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
Effective written and oral communication skills as well as presentation skills
Knowledge and application of industry best practices not yet represented by global regulatory requirements
Full theoretical and hands-on understanding and knowledge of general chemistry and separation science
Demonstrated ability of integrating changing regulatory or industry standards and comprehension of technical limitations
Full understanding of laboratory requirements, SOPs, ICH guidelines, USP requirements and FDA guidance
Ability to independently review and understand project proposals/plans
Proven ability in technical writing skills
Ability to work in a collaborative work environment with a team
Proven problem solving and troubleshooting abilities
Ability to independently optimize analytical methods
Time management and project management skills

Responsibilities

Independently plans the best scientific approach to develop analytical methods and/or other specialty technologies studies that meet client requirements.
Acts as on-site Subject Matter Expert (SME) for instrumentation / technique / technology.
Evaluates available technical options to obtain desired quality of analytical results, economics, ease of introduction into a production environment, and robustness in analytical applications.
Demonstrates viability of in-house developed methods and methods transferred from clients by designing appropriate validation experiments or other appropriate aspects of specialty methodology or technology.
Ability to lead client discussions regarding project definitions, technical information exchanges and discussions of project status.
Provides recommendations to clients on technical and regulatory issues.
Reviews protocols, project status reports, final study reports and other project related technical documents.
Assists business development group in technical sales and marketing, and in preparation of technical marketing materials, and presents posters and makes podium presentations at 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