| Method Validation Engineer at Thousand Oaks, California, USA |
| Email: [email protected] |
| From: Syed Anwer, ConvexTech Inc [email protected] Reply to: [email protected] Job Title: Method Validation Engineer Location: Thousand Oaks, CA Onsite Duration: 6-12 month contract Anticipated start date in August Job Description Qualifications: Bachelor's Degree or superior 2-5 years of manufacturing, quality or engineering in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field Strong understanding of the underlying principles of chemistry, as well as knowledge of laboratory safety and best practices Familiar with ICH Q2 method qualification/validation requirements Familiar with the USP, EP, and JP Pharmacopeia Hands on analytical instrumentation experience is preferred Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, and experience with a wide range of analytical techniques. Strong verbal and written communication skills Essential Duties and Responsibilities: Plan, prioritize, execute, and implement analytical assays Wet Chem experience necessary. Support QC method technical transfers Develop validation protocols for QC analytical instruments Develop test/compendial method validation protocols for one or more of the following tests: Thermo Scientific Antaris II FT-NIR, with TQ Analyst and RESULT software Eppendorf Vacufuge concentrator, or equivalent Near Infrared Spectroscopy, (TruScanTM Raman Analyzer) Raman Spectroscopy, (Thermo Nicolet iS10 FT-IR with computer installed with OMNIC software) SDS-PAGE HPLC Methodology/Assays for large molecule (proteins) Protein/Bio-Assays ELISA and other related assays UV Spectrophotometry (Protein Concentration) Mammalian / Human cell culture experience including: Cell count and culture maintenance Automated Cell Counting (LUNA Cell Counter) Metabolite Analysis (BioProfile FLEX Instrument) Cellular Morphology and Viability Demonstrated method troubleshooting capability Knowledge, skills, and expertise in performing chemical experiments that involve the use of liquids, or "wet" chemicals Raw Materials: techniques such as wet chemistry compendia testing, Raman, NIR, titration assays, gas testing Preparing chemical solutions, conducting chemical reactions, and analyzing chemical compounds using various wet chemical techniques such as titrations, extractions, filtrations, and precipitation ConvexTech Syed Anwer Lead Talent Acquisition | Staffing & Recruitment Phone: 214-295-3794 Text Now: 214-296-2578 Email: [email protected] https://www.linkedin.com/in/syed-anwer-a81a76114/ ConvexTech Inc. 10027 Park Meadow Dr Houston TX 77089. Keywords: business analyst California Texas |
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| Tue Jul 18 03:07:00 UTC 2023 |