Location: all cities,CA, USA
Analytical Development Scientist
Looking for mid-level candidates (MS with 6 years ideally but based on bill rate may have to look at 3-5 years), open to PhD candidates.
Skills: Working knowledge and experience performing analytical assay techniques such as absorbance (UV) assays, SDS-PAGE, ELISA, liquid chromatography ((U)HPLC), mass spectrometry (LC-MS and/or MALDI), CE-SDS, icIEF.
1 year contract
Newark, CA
JOB SUMMARY:
Seeking a Scientist to contribute to our growing Analytical Development team. The incumbent will participate in a team responsible for all aspects of method development, optimization, qualification/validation, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for our projects.
This is an on-site, technical laboratory-based position that involves analytical testing of biologics. Occasional remote work may be approved on a case-by-case basis. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, Formulation Development, Research and Development, QC, and other technical groups by providing analytical testing support.
ESSENTIAL DUTIES and RESPONSIBILITIES:
Execute technical analytical methodologies to support development and qualification/validation of test methods.
Assist in writing and reviewing of analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control where needed.
Operate, maintain, and install sophisticated analytical instrumentation and associated computer control systems.
Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development.
Provide support for laboratory operations inventory tracking, reagent/solution preparation, sample management, and documentation review.
Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
Ensure adherence to GxP guidelines where required.
Occasional weekend work may be needed based on timelines.
QUALIFICATION REQUIREMENTS:
Working knowledge and experience performing analytical assay techniques such as absorbance (UV) assays, SDS-PAGE, ELISA, liquid chromatography ((U)HPLC), mass spectrometry (LC-MS and/or MALDI), CE-SDS, icIEF.
Experience following protocols and SOPs.
Be able to fluently communicate across technical and operational activities and work collaboratively to ensure successful execution.
Strong written and verbal communication skills.
Working knowledge of statistics.
Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
Self-motivated, proactive and driven individual with an interest in experimental design and development.
STRONG PREFERENCE FOR:
Expert level understanding of LC-MS/MS and MALDI.
Education:
Masters degree with 6+ years of industry experience; PhD with 4+ years of industry experience.
Pay Rate Range: $35-55/hr depending on experience