Scientist II, Analytical Method Development
3-month contract with likelihood of extenstion/conversion
The Scientist II, AMD, is responsible for supporting development, prequalification and qualification/validation of a wide range of large molecule focused ELISA based bioassays and other protein characterization/assay or potency methods within the Analytical Method Development (AMD) group. This position is a hands-on bench role.
• Experience in development and tech transfer of quantitative binding activity ELISAs for a wide spectrum of large molecules and targets. Optimization and implementation of ELISA commercial kits for assessment of impurities or protein concentration (e.g., Host cell proteins, residual leachates, etc.)
• Performs method pre-qualification and qualification/validation, authors analytical test methods/qualification protocols, development and prequalification reports and supports method transfer to the Quality Control laboratory.
• Specification and acquisition of critical reagents to ensure rapid method establishment, optimization and development. Responsible for establishing critical reagents, optimal long-term storage condition and supply .
• Supports potency methods with ability to manage multiple projects and provide regular internal and external progress updates with clients and sites
• Experience in analytical methods such as Western blots, Protein Titer (HPLC, ELISA. BioLayer Interferometry (BLI) and SPR)
• Reviews and interprets complex data and performs statistical analyses by using appropriate software (e.g. PLA, JMP, etc).
• Communicates scientific data and concepts effectively through presentations, protocols, test methods and reports.
• B.S. degree ≥ 5 years, M.S. with ≥ 3 years or Ph.D. ≥ 2 years industrial experience in a relevant discipline, (e.g., chemistry, biochemistry, biological sciences, bioengineering, etc.).
• Experience in method development/optimization, qualification and validation of analytical methods in areas related to non-cell-based bioassays and ELISA Immunoassays.
• Knowledge and application of analytical technologies in Western blots, Protein Titer (HPLC, ELISA and SPR) and other analytical protein methods.
• Knowledge and experience in cGMP, ICH guidelines, USP and EP compendial methods.
• Good oral and written communication skills.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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