Research Scientist - Large Molecule

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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

Job Description

Research Scientist/Sr Research Scientist – Large or Small Molecule

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

Discover Impactful Work:
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 (HPLC, GC, UPLC, ICP-MS, 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.

What You'll Do:

• 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

Education and Experience:

• 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 requirement