Job Description
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them.
Location/Division Specific Information
Work Location: St. Louis, MO (on-site)
Group: Pharma Services Group
Division: Drug Substance Division
How will you make an impact?
As a Raw Material Scientist, you will provide moderately sophisticated analyses in a chemistry environment within defined procedures and practices. Performs analytical methods for moderately complex testing on raw materials, stability, production intermediates and/or environmental monitoring samples. Supports process improvement initiatives and/or manufacturing operations. Makes detailed observations, reviews documents, and communicates test results; recommends solutions.
What will you do?
Conduct moderately sophisticated chemical and physical testing of pharmaceutical raw materials, packaging components and/or finished products samples by internally developed and compendial test methods.
Execute validated test methods for strength, impurities, identity, and dissolution using HPLC, GC, dissolution, spectroscopy, traditional quantitative analysis, and/or traditional wet chemical testing.
Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions. Responsible for authoring QC deviations and laboratory investigations.
Maintain and troubleshoot analytical instrumentation as needed. Clearly and accurately communicate the results of work by documenting the testing/analysis and acquired results.
Record and report results of analysis in accordance with prescribed lab procedures and systems.
Prepare and assist in filing regulatory documents in support of internal projects. Provide communications with outside departments, corporate sites, agencies, and clients.
Write SOPs and other instructional documents. Clean and organize work area, instrumentation, and testing materials.
Clean HPLC and dissolution systems after use.
Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the vital compliance status required by company and facility standards.
How will you get here?
Education
Associates Degree required
Bachelors degree, preferably in Biology, Biochemistry, Chemistry, STEM degree preferred
Experience
2+ years of performing tests or analyses for pharmaceutical raw materials or finished products.
2+ years’ experience with common office software and chromatographic data acquisition systems.
1+ year of experience in writing deviations and laboratory investigations is a plus, but not required; Trackwise experience is a plus
1+ years of experience in the biopharmaceutical or pharmaceutical industry highly preferred
2+ years of experience using analytical laboratory instrumentation such as HPLC, GC, and IC
Equivalent combinations of education, training, and meaningful work experience may be considered.
Knowledge, Skills and Abilities
Proficient knowledge and understanding of chemistry and analytical instrumental technologies.
Proficient knowledge of qualitative and quantitative chemical or microbiological analysis.
Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs and descriptive organic chemistry.
Good problem-solving skills and logical approach to solving scientific problems.
Good interpersonal and communication skills (both oral and written). Good presentation skills to present information to customers, clients, and other employees.
Ability to read, analyze, and interpret technical procedures and governmental regulations. Ability to write SOPs, simple protocols, and reports.
Ability to respond to common inquiries or complaints from customers or regulatory agencies. Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.
Physical Requirements
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time approximately 90% of shift; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Personal Protective Equipment (PPE) required including but not limited to safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally, as the need arises.
90% Standing/Walking, able to stand for long periods, 10% Sitting at Desk/Office
Exposure to fumes, chemicals, acids, and bases.
Ability to lift up to 30 pounds.
Overtime may be required to support testing deliverables.
This position has not been approved for relocation assistance.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
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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.