Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, ensuring our food is safe or helping find cures for cancer.
Location/Division Specific Information
Position reports to the St Louis, MO site, and supports the Drug Substance Division.
Discover Impactful Work:
In this role you will use numerous analytical tools used for large molecule analysis, such as CGE, iCE/iCIEF and other minor equipment. This work will be supporting GMP manufacturing for early and late state clinical and commercial efforts (In-Process) along with Stability testing and other endeavors requested by the client. This role will require experience in working in a cGMP environment. The candidate should be familiar with using Empower software. MS Office experience is required.
A Day in the Life:
Perform CGE/iCE testing on In-Process, DS release, DP release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects
Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis.
Conduct GMP testing in an analytical laboratory environment using CGE and iCE/iCIEF test methods (i.e.,Reverse Phase, SEC, Titer concentration, CEX, etc)
Compiles data for documentation of test procedures, prepares reports. Ensures all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards.
Participate in the development of new concepts, techniques, and standards. Involved with assisting in the preparation of CoAs.
Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions.
Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines
Partake in laboratory activities, including safety inspections and client audits in a timely matter.
Keys to Success:
Education
Required: Bachelor's degree in chemical pharmaceutical, biology, chemistry, biotechnology or related field.
Experience
At least 3 years of related experience in a regulated environment required.
CGE/iCE experience in pharma, or a related relevant field required.
Knowledge, Skills, Abilities
Flexibility.
Organization and planning skills.
Ability to work in a team.
Attention to details.
Positive demeanor.
Knowledge MS Office program.
In-depth knowledge of the most common analytical techniques and required instrumentation.
Knowledge of notions and laboratory computer programs (Empower, LIMs, TrackWise).
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!
