Research Scientist / Sr Research Scientist - Large Molecule

Job Description

Research Scientist/Sr Research Scientist – Large 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 (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. What You'll Do:

• 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

Education and Experience:

• Bachelor's degree in lab sciences such as Chemistry, Biochemistry, Material Science, Immunology, Biology, Molecular Biology or similar
• RS/SRS: · 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

Benefits 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 offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Working Conditions and Environment: Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.