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Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Analytical Scientist - Ware UK
Thermo Fishers 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.
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 theanalytical work will be sought to guide future work. A person with an innate scientific curiosity and keen observation skillswill 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.
Education and Experience:
Bachelors 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 0-2years)
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
If you resonate with our 4i values above and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the worlds most urgent health needs submit your application wed love to hear from you!
Full-Time