PDS Tech Inc QC Bioassay Scientist in Saint Louis, Missouri
PDS Tech, Inc. is seeking QC Bioassay Scientist in St. Louis, MO
How will you make an impact?
The QC Analytical Scientists primary responsibility is to perform routine to complex QC testing pertaining ELISA testing and Cell Based Assays in accordance with cGMP regulations and Thermo Fisher standards to meet departmental and organizational goals. This position entails testing for GMP release and stability along with support for the validation and qualification of ELISA and Cell Based Assays. Additional responsibilities include supporting the department to establish robust work processes and assess for continuous improvement opportunities.
The QC Analytical Scientist will report directly to the QC Analytical Bioassay Supervisor.
What will you do?
Perform in-lab assay execution support for validation, qualification studies, and routine testing by ELISA and cell-based bioassays.
Revise/review specifications, SOPs, and other documents regarding QC-Analytical testing and assay execution.
Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance.
Effectively communicate with peers, manufacturing, AD and QC staff, to resolve technical issues and direct activities.
Provide support to site Safety initiatives.
Perform any other tasks as requested by Senior Management to support Quality oversight activities.
How will you get here?
- Bachelors Degree in a Biological Science or related field
2+ years of experience within the biopharmaceutical or pharmaceutical industry, preferably in ELISA or cell-based bioassay field.
Extensive knowledge of GMP regulations in a cGMP manufacturing environment.
Working Knowledge of scientific principles for wide range of analytical techniques strongly preferred. ELISA and Cell Based Assay experience with large molecules is strongly recommended.
Routine use of MS Excel, MS PowerPoint, and MS Word is essential
Knowledge, Skills, Abilities
Ability to understand customer requirements related to Quality control, including processes and equipment.
Outstanding technical writing skills.
Highly organized with attention to detail
Ability to communicate clearly and professionally in writing and verbally
Flexibility in problem solving, providing direction and work hours to meet business objectives
Working knowledge in 5S, SAP, and Trackwise preferred
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.