Marin Metro Area, CA
The selected Research associate will support analytical chemistry activities for development of biologics and gene therapy. An ideal candidate will have hands-on experience with analysis using HPLC, GCMS, LCMS, ICPMS, and other analytical techniques. Candidate will make detailed observations, analyze data, and interpret/present results.
The prospective Individual should be familiar with and be able to follow Standard Operating Procedures (SOPs) for experimental operation and data recording. This is a laboratory-based position and the candidate must be familiar with general laboratory operations. Familiarity with GxP quality guidelines and USP/ICH guidelines is a plus
The Research Associate I/II, functions to manage, coordinate, and perform activities required for the testing of extractables and leachable samples, drug substances, drug products, cell culture, and human/animal specimens, as expected during various stages of drug development.
In this position the candidate will work closely with Scientists in the analytical chemistry group and support development, qualification, validation, and testing activities of HPLC, GCMS, LCMS, and ICPMS based analytical methods and assays.
The selected candidate should possess excellent analytical, organizational and communication skills and be a self-starter willing to work efficiently and collaboratively in a dynamic environment. Activities included, but not limited to be:
Preparation of assay reagents and buffers.
Perform HPLC, GC-MS, LC-MS, and ICP-MS based assays to quantify analytes from various complex matrices.
Perform quantitative analysis of data and interpretation of experimental results.
Be able to develop and optimize new GC-MS, LC-MS, and ICPMS based protocols.
Prepare and deliver effective oral presentations in meetings.
Follow all relevant GxP (GLP, GCP, GMP), appropriate to drug development phase.
Maintain good and timely documentation of experiments
Contribute to and provide solutions to technical problems and think creatively.
Help drafting and review of technical reports, protocols, analytical test procedures, and SOPs
Follow SOPs, policies, instructions, and regulations, and to perform routine lab equipment maintenance is required.
Experience in extractables and leachables analysis and impurity characterization
Experience in analytical method development, method qualification, method validation, and method transfer.
Experience in GxP environment and knowledge of USP/ICH regulatory requirements is plus.
Knowledge of biochemistry, bioanalytical chemistry, polymer and organic chemistry is plus.
B.S. in the Analytical Chemistry, Pharmaceutical Sciences, Biochemistry, Biophysical Chemistry or related discipline.
1-2+ years of relevant laboratory experience in a pharmaceutical/R&D environment
Excellent knowledge in GC, GC-MS, HPLC, UHPLC, LC-MS, and ICP-MS for analysis of samples.
Working knowledge of Microsoft Excel, Word, and PowerPoint.
Strong problem-solving, documentation and organizational skills with a focus on details and results.
Strong interpersonal, communication and presentation skills and the ability to thrive in a fast-paced dynamic environment.
Ability to work in a team environment.