770 Lindaro St San Rafael, CA 94901 | Contract
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- The Contract Analyst under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples.
- Contract Analysts work independently on assays that he/she has mastered.
- They must be able to work on projects with little supervision, write and execute method validation and special studies, and have some oversight of a product line.
- Perform, under moderate supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
- Work independently on assays that he/she has mastered.
- Evaluate data against defined criteria/specifications.
- Maintain laboratory supply inventories.
- Maintain the laboratory in an inspection-ready state.
- Provide support for glassware cleaning and other routine laboratory functions/chores for the QC laboratory.
- Develop and maintain proficiency in a broad range of test methods.
- Assist in the revision of written procedures as assigned.
- Assist in the preparation of routine and non-routine study protocols and reports.
- Train other analysts in areas of expertise.Develop familiarity concerning cGMP, 21CFR, USP, EP, and ICH regulatory.
- At least one year in a cGMP/GLP laboratory; quality control experience is preferred.
- Ability to follow written instructions and to perform tasks with direct or minimal supervision.
- Familiarity with use of a computer: e.g.
- Proficient in Windows, Microsoft Word, Excel,Good written, verbal, and communication skills.
- Strong documentation skills.
- Bachelor's Degree in science (major in biology-biochemistry-chemistry).
- 0-2 years of experience.