Quality Control Associate

Quality Control Associate
  • $30 - $65 per Hour
  • Temporary
  • San Diego CA, US San Diego SAN DIEGO US
Job Ref: JO000110098
Sector: Science
Sub-sector: Science- Bio
Date Added: 13 January 2021

Scientist II, Analytical Method Development

3-month contract with likelihood of extenstion/conversion

Overall Responsibilities:
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.

Position Responsibilities:
• 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.

Qualifications/Skills Required:
• 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.

27/01/2021 12:00:00
USD 30.00 30.00
Contact Consultant:
Ryan Heavirland

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