Scientist, Biopharma - Client Dedicated

Within our Analytical Services team at the client site, we have a functional service provider solution, which is an outstanding partnership that allows our customers to use the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. Summarized Purpose: This role will be supporting the development of innovative drug delivery approaches, and feedback/observations from the analytical work will be sought to guide future work. A person with an innate scientific curiosity and keen observation skills will have the opportunity to impact the future medicine development. The role of Scientist is to perform a variety of analysis and sample preparation procedures to quantitatively measure small molecules and biotherapeutics using a wide range of analytical instrumentation available (such as HPLC, SEC, CEX and LC-MS). Working mainly independently, Scientists will interpret analytical data in regard to acceptability and consistency and set up and maintain analytical instrumentation. The role is a full-time onsite position at the client site to provide continuous ongoing support to the client's analytical needs. Essential Functions:

• Perform a variety of routine sample preparations and analysis procedures to quantitatively measure large molecule and biopharmaceutical compounds.
• Provide analytical support for the testing of a variety of samples from GMP and non-GMP studies for Toxicology assessment, discovery, process research and development.
• Perform work assignments accurately, with the highest quality, in a timely and safe manner.
• Set up analytical instrumentation for analysis using appropriate methods.
• Support the routine operation and occasional maintenance of analytical instrumentation, SOPs and regulatory procedures and guidelines.
• Communicate analytical results to the required team and group leaders in required documentation.
• Problem solving, either independently or with assistance, pertaining to extraction and/or instrumentation problems.
• Provide additional 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 Degree in Chemistry, Organic Chemistry, Chemical Engineering, Pharmaceutical Science or similar
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 2+ years) or equivalent combination of education, training, & experience.
OR
• Masters degree and previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 1-2 years)
Knowledge, Skills and Abilities:
• 1+ years of experience with chromatography such as HPLC (SEC for antibodies) in a regulated GMP lab is required.
• Knowledge of general chemistry and separation science.
• Ability to work with multiple testing platforms and tasks simultaneously to meet client needs.
• Ability to work in a collaborative work environment with a team.
• Ability to support root cause analysis for method investigations.
• Ability to support other team members in other analytical techniques (such as KF, ICP).
• Time management and project management skills.
• Experience with Empower software would be useful (ideally SEC for antibodies).
• Experience in Mass Spectrometry would be useful (Glycan analysis of antibodies, Intact mass).
• Immunoassay/bio residual experience would be useful (quantitative ELISA, SPR,qPCR).
• Experience in analytical problem solving and troubleshooting abilities would be beneficial.
• Proficiency on technical operating systems.
• Good written and oral communication skills.
  
  Thermo Fisher's clinical research business is a leading global contract research organization (CRO) and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our clients to make the world healthier, safer, and cleaner.