Scientist FSP

Within our Analytical Services team, 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. Essential Functions:

• Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations and /or biological matrices for stability and analytical testing.
• Sets up and maintains analytical instrumentation.
• Trains on routine operation, maintenance and theory of analytical instrumentation, SOPs and regulatory procedures and guidelines.
• Ensures QA findings are addressed appropriately.
• Problem solving, either independently or with assistance pertaining to extraction and/or instrumentation problems.
• Communicates project status to project leader.
• Performs work assignments accurately, and in a timely and safe manner.
• 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 or equivalent and relevant formal academic / vocational qualification
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 0-2 years)
Knowledge, Skills and Abilities:
• 1 plus years of experience with HPLC, KF, Dissolution, in a regulated GMP lab is required.
• Experience with Empower software
• Demonstrated knowledge of multiple applicable techniques such as HPLC, KF and dissolution testing is required.
• Experience in inhalation testing is desirable
• Knowledge of general chemistry and separation science
• Ability to independently perform root cause analysis for method investigations
• Proficiency on technical operating systems
• Proven problem solving and troubleshooting abilities
• Proven ability in technical writing skills
• Time management and project management skills
• Good written and oral communication skills
• Ability to work in a collaborative work environment with a team
• Ability to train junior staff
Our 4i Values: Integrity - Innovation - Intensity - Involvement

Thermo Fisher's clinical research business is a leading global contract research organization 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.