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Theradaptive is revolutionizing the field of therapeutic delivery with a pipeline of best-in-class products that address multiple global markets. Theradaptive is performing cutting edge science in the area of regenerative medicine, working at the interface of Biology and Orthopedic tissue repair. Our lead therapeutics are in the following indications: Spinal Fusion;Long Bone Repair;Osteochondral Repair;Dental and Facial Bone Repair;Immuno-Oncology. We are an innovative, fast-paced team that is advancing a diverse array of cutting-edge translational research projects.
Job Responsibility
Assist in the development and optimization of analytical methods using Chromatography (SEC-HPLC, RP-HPLC), moisture/water content determination (including Karl Fisher) and/or electrophoresis (cIEF, CE-SDS) techniques for the release and characterization of biologics and drug product/medical devices
Execute laboratory experiments, including sample testing and characterization of biologics using chromatography, UV spectroscopy, electrophoresis, and/or immunoassay and cell-based assays
Perform sample testing, analyze data, interpret results, and contribute to the preparation of reports in various formats, including Laboratory Notebooks (LN), formal reports, and presentations
Assist in the creation and review of Standard Operating Procedures (SOPs) for test method procedures and laboratory equipment operation and execute method qualification and validation studies
Ensure proper qualification, calibration, and maintenance of laboratory equipment in accordance with established schedules
Adhere to cGMP requirements as necessary and uphold compliance with standard operating procedures to maintain quality standards
Collaborate effectively within a team environment, demonstrate attention to detail, and communicate effectively verbally and in writing
Use standard laboratory, data analysis, and GMP quality systems, including Excel, GraphPad Prism, Laboratory Notebooks (LN), instrument software, and electronic quality systems, to support analytical development, testing, data review, investigations, trending, and compliant documentation
Adherence to laboratory and workplace safety protocols, proper use of personal protective equipment (PPE), hazard identification and reporting, and comply with the company's safety policies
Undertake any additional duties and responsibilities as needed to support the objectives of the laboratory
Requirements
Bachelor's or Master's degree in Biochemistry, Pharmaceutical Analysis, Biotechnology, or Analytical Chemistry
Bachelor's degree with at least 5 years or Master's degree with at least 3 years of industry laboratory experience