Analytical Chemistry Scientist II
San Diego, CA - Onsite
Schedule:
Standard Working Hours
Duration:
10-Month Contract (with potential for extension or conversion to full-time)
Pay:$39-44/hr (W2)
Our client is a leading global biotechnology company. They are seeking an Analytical Chemistry Scientist II to backfill a contractor position in their Reagent Development Services – Analytical Method Development and Transfer Group. This onsite role requires strong knowledge of chromatographic, spectroscopic and enzymology assay techniques with hands-on experience developing high quality and robust analytical methods. Extension or conversion to full-time is possible if the position becomes available.
Essential Functions and Responsibilities
- Plan and execute various laboratory experiments under general direction
- Develop, validate and transfer test methods according to Good Manufacturing Practice (GMP) and/or regulatory requirements (FDA 21 CFR Part 11 and ISO)
- Prioritize assignments and deliver results within project timelines
- Perform data analysis and troubleshoot aberrant results and draw sound conclusions
- Prepare study protocols and reports and write assay work instructions
- Observe and comply with GMP and Good Documentation Practice (GDP)
- Work with all members of staff to maintain and develop the positive progressive culture
- Perform collaborative experiments with team members across multiple disciplines
Education and Experience
- Bachelor's degree in Science (Analytical Chemistry, Chemistry, Biochemistry, Molecular Biology, or similar scientific field)
- Minimum 2 years of experience in analytical method development, qualification, validation and transfer using various analytical techniques such as UHPLC, LC-MS, CE, UV, NMR, Fluorescence plate readers, enzyme activity assays, etc.
Knowledge and Skills
- Strong knowledge of chromatographic, spectroscopic and enzymology assay techniques
- Hands-on experience in development of high quality and robustness analytical methods using UHPLC, LC-MS, UV, etc.
- Analytical method qualification, validation and transfer experience
- Knowledge and working application of method validation principles for regulated industries including FDA cGMP; ICH/USP guidelines, ANSI/ISO/ASQC
- GMP knowledge preferred
- Highly proficient, productive, and effective in the lab with excellent lab organization and documentation skills
- Excellent verbal/written communication and interpersonal skills
- Strong communication and collaboration skills
- Strong attention to details
- Analytical, detail-oriented, organized, takes initiative, and self-motivated
- Flexible and adaptable
- Adaptability to changes on projects priority and deliver results per project timelines
- Ability to work cross-functionally on different projects with team members
- Multi-tasking between labwork and projects
- Willing to stay late or come early if there is a need
- Hands on experience with Next Gen Sequencing (NGS) technologies a plus
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