QC Scientist III

Thermo Fisher Scientific•Saint Louis, MO

1d•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Preferred Fields of Study: Chemistry, Biology, Biochemistry, or related scientific field
Experience mentoring team members preferred

Responsibilities

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.