| : Quality Analyst at Remote, Remote, USA |
| Email: [email protected] |
| From: Aniket Dhakar, Technocraft Solutions [email protected] Reply to: [email protected] Job Title: Quality Analyst Location: Oaks, CA/ Boston, MA - Onsite JOB DESCRIPTION My client is building a dynamic team of QC Analysts to provide a growing analytical method development and transfer service. In this exciting new role, you will join a team of highly skilled analysts focused on developing and transferring robust analytical methods for our clients in the biopharmaceutical industry. You will work collaboratively with clients to understand their specific needs and develop efficient and reliable QC methods. Key Responsibilities: Plan, prioritize, execute, and implement analytical assays for a variety of QC applications. Support technical transfer of QC methods from development to manufacturing. Conduct feasibility studies for new QC analytical methods. Execute test method validation protocols for a variety of analytical techniques, including: Appearance Peptide Mapping-HPLC SDS-PAGE by Western Blot (LEX, Legacy) Reverse Phase-HPLC Size Exclusion-HPLC Cellular Uptake (Bioassay) Kinetic Activity Specific Activity Protein Content and Uniformity LAL (Bacterial Endotoxins) Sterility Moisture Content Osmolality Particulates pH Western ID test for DS satellite sample Reconstitution Procedure SDS -PAGE Coomassie (CE-SDS replacement methods) Protein Concentration (UV Absorbance) Troubleshoot and resolve issues related to analytical methods. Perform chemical experiments involving "wet" chemistry techniques. Prepare chemical solutions, conduct chemical reactions, and analyze chemical compounds using techniques such as titrations, extractions, filtrations, and precipitation. Qualifications: Bachelor's degree in Chemistry, Biochemistry, or a related field (Master's degree a plus). Minimum 5 years of experience in a manufacturing, quality control, or engineering role within the biopharmaceutical industry. Strong understanding of the principles of chemistry, laboratory safety procedures, and best practices. Familiarity with ICH Q2 method qualification/validation requirements. Working knowledge of pharmacopeias such as USP, EP, and JP. Prior experience with analytical instrumentation (e.g., HPLC, Western Blot) is preferred. Knowledge of cGMP compliance requirements for QC laboratories and experience with a wide range of analytical techniques. Excellent verbal and written communication skills. Aniket Dhakar Recruiter Technocraft Solutions, LLC Email: [email protected] LinkedIn: https://www.linkedin.com/in/aniket-dhakar-003482245/ www.technocraftsol.com Keywords: container edition California Idaho Massachusetts : Quality Analyst [email protected] |
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| Thu May 09 20:06:00 UTC 2024 |