• QC Scientist III

    ThermoFisher Scientific (St. Louis, MO)


    Work Schedule

     

    Standard (Mon-Fri)

     

    Environmental Conditions

     

    Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    Job Description

    How will you make an impact?

     

    Join our collaborative team at Thermo Fisher Scientific, where you'll contribute to our mission of making the world healthier, cleaner, and safer. As a QC Scientist III, you'll perform sophisticated analytical testing and provide quality oversight for biopharmaceutical products. You'll work with advanced technology and collaborate with cross-functional teams to ensure product safety and compliance with regulatory requirements. This role offers significant opportunities to grow your expertise while supporting the development and manufacturing of life-changing therapeutics.

     

    You'll conduct complex analytical testing, lead method validations, perform data review, and troubleshoot technical issues. Key responsibilities include executing and reviewing tests for product release, stability, and in-process samples; authoring and reviewing technical documentation; participating in investigations; and interfacing with clients and regulatory authorities. Your work will directly impact patient safety and product quality while advancing scientific innovation.

     

    A Day in the Life:

    + Conduct GMP testing in an analytical laboratory environment using Separation Techniques, BioAssay Analysis and Compendia test methods (i.e.,Reverse Phase, SEC, Titer concentration, iCE, pH, Osmolarity, Residual DNA, Appearance)

    + Help develop and build the foundation of a liquid chromatography technical team by implementing standard practices and policies.

    + Perform testing on In-Process, DS release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects

    + Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions

    + Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis.

    + 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.

    + Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines

    + Participating in laboratory activities, including safety inspections and client audits

    + Communicate findings and discuss relevance of your data to a multi-discipline team consisting of upstream and downstream process development scientists, quality control, quality assurance, process engineers and our customers.

    Keys to Success:

    • Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in GMP pharmaceutical/biopharmaceutical quality control

    • Preferred Fields of Study: Chemistry, Biology, Biochemistry, or related scientific field

    • Expertise in analytical techniques such as HPLC, UPLC, CE-SDS, cIEF/ICE, ELISA, and cell-based assays

    • Strong knowledge of FDA, EMA, ICH, and GxP regulations

    • Experience with method validation, transfer, and qualification

    • Proficiency in data analysis and laboratory information management systems

    • Advanced technical writing and documentation skills

    • Strong project management and organizational abilities

    • Excellent interpersonal and communication skills

    • Ability to work independently and lead cross-functional teams

    • Experience with quality investigations and CAPAs

    • Proficiency with Microsoft Office Suite and relevant analytical software

    • Ability to wear PPE and work in laboratory environments

    • May require weekend/flexible scheduling based on business needs

    • Physical requirements include standing, lifting up to 25 lbs, and manual dexterity

    • Strong attention to detail and problem-solving skills

    • Experience mentoring team members preferred

    Excellent Benefits

    + Benefits & Total Rewards | Thermo Fisher Scientific (https://jobs.thermofisher.com/global/en/total-rewards)

    + Medical, Dental, & Vision benefits-effective Day 1

    + Paid Time Off & Designated Paid Holidays

    + Retirement Savings Plan

    + Tuition Reimbursement

    OTHER

    + Relocation assistance is NOT provided.

    + Must be legally authorized to work in the United States now and in the future, without sponsorship.

    + Must be able to pass a comprehensive background check, which includes a drug screening.

     

    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.