Job Description:
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, 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.)
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, making sure 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 HPLC, UPLC and other minor equipments. 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.
A Day in the Life:
- Perform HPLC/UPLC testing on In-Process, DS release, DP release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects
- Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods (i.e.,Reverse Phase, SEC, Titer concentration, CEX, etc)
- Compiles data for documentation of test procedures, prepares reports. Collaborate with team members and other departments such as quality assurance and data reviewers.
- Contributes to the development of new concepts, techniques, and standards.
- Recognize and report invalid/ lab incident/ out-of-specification/ out-of-trend results to laboratory management; recommend solutions.
- Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, and Safety guidelines.
- Participate in laboratory activities, performing safety inspections and ordering supplies.
Keys to Success:
Education
- Required: Bachelor's degree in chemical pharmaceutical, biology, chemistry, biotechnology or related field.
Experience
- At least 1 year proven experience in a regulated field is required in a similar, or related job function.
Knowledge, Skills, Abilities
- In-depth knowledge of the most common analytical techniques and required instrumentation (HPLC, UPLC, etc..).
- Knowledge of MS Office and laboratory computer programs.
Personality traits:
- Flexibility.
- Good organization and planning skills.
- Attention to details.
- Positive and collaborative demeanour.
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!
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