Research Scientist ​/ Sr Research Scientist - Large Molecule

Work Schedule

Standard (Mon-Fri)

Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Shift: Full-Time;
Monday – Friday; 8am-5pm EST

• Large Molecule / Biologics Testing Background MUST HAVE
• 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

• 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’)
• 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.

Knowledge, Skills and Abilities:

• 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

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We…