at Thermo Fisher Scientific in North Chicago, Illinois, United States
Job Description
Job Description
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 customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage 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:
In this position as a Scientist, you should possess a thorough understanding of laboratory procedures and can reliably conduct complex analysis with increased independence. You will perform a variety of complex sample preparation and analysis procedures to measure pharmaceutical and biopharmaceutical compounds. Instrumentation is mainly large molecule HPLC (such as SEC, IEX or RP) and icIEF/CE-SDS. Follows validated or experimental analytical procedures with periodic direct supervision. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. Enters data into databases and reports. Performs self-review for own data prior to QC submission.
Essential Functions:??
+ Performs a variety of complex sample preparation and analysis procedures to quantitatively measure pharmaceutical and biopharmaceutical compounds in a variety of formulations for stability and analytical testing.
+ Works with multiple functional groups to meet business needs.
+ Plans and organizes work with periodic supervision.
+ 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.
+ Aids in training to other team members.
+ Problem solving and instrument troubleshooting, either independently or with assistance.
+ 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.
Qualifications – External
Education and Experience:?
+ 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 to 2+ 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:
+ Demonstrated knowledge of multiple applicable techniques such as: Compendial analysis, Coulometric Karl Fisher, UV-VIS, HPLC, and other biopharmaceutical testing.
+ At least one year of cGMP experience in a regulated lab is required.
+ Proficient in Microsoft Excel and Word.
+ Proficient in Empower.
+ Proven ability to interpret data by performing trend analysis.
+ Proven ability in technical writing skills.
+ Ability to independently optimize analytical methods.
+ Proven problem solving and troubleshooting abilities.
+ Good written and oral communication skills.
+ Time management and project management skills.
+ Ability to work in a collaborative work environment with a team.
+ Ability to be flexible and be able to re-prioritize in a short notice to meet business needs.
Working Environment:?
PPD, part of Thermo Fisher Scientific values the health and well-being 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.
+ As a condition of employment with PPD, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.
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 world’s most urgent health needs, submit your application – we’d love to hear from you!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
