At Codexis we believe in harnessing the power of biology to improve the health of this planet and its inhabitants. Codexis, Inc. (Nasdaq: CDXS) is a protein engineering industry leader with successful track record of developing novel enzymes used as biocatalysts for the commercial production of small molecule pharmaceuticals, diagnostic tools, chemicals used in the food industry, as well as multiple other applications. Codexis has also applied its CodeEvolver technology platform to discover and develop novel biotherapeutics for the treatment of rare genetic disorders, among other indications with significant unmet medical need. We create value by engineering innovative biological solutions to meaningful challenges.
We are seeking a highly motivated and detail-oriented Quality Control Lead to oversee day-to-day QC operations and analyses of biocatalysts (enzymes). The successful candidate will also review analytical data and prepare/review documentation. This position reports to the Associate Director of Quality Control.
- Provide technical oversight, coordinate and review QC analytical testing of commercial products and maintains the department work schedule.
- Coordinate day-to-day operations within the lab to ensure that products are tested, and that data is reviewed/approved according to project timelines.
- Responsible for laboratory notebook review and data documentation for commercial products.
- Administer the stability study program by managing the pull schedule, scheduling testing, compiling/reviewing stability reports and performing stability data trending.
- Assist in writing quality documentation including, but not limited to, change controls, deviations, and corrective/preventive actions for QC operations.
- Assist in laboratory investigations for deviations and OOT/OOS with management of the root cause analysis process.
- Oversee and manage the equipment calibration program, write and review IQ/OQ/PQ protocols and reports.
- Oversee the QC sample inventory and establish processes to manage reagent inventories for lab use.
- Perform analytical testing of finished product and development samples.
- Bachelor’s Degree in Analytical Chemistry, Biochemistry or equivalent.
- 8+ years of industrial QC experience in pharmaceutical, medical device or biologics industry.
- Leadership skills with a strong background in analytical chemistry and/or biochemistry
- Working knowledge and experience with GMP regulations and good documentation practices.
- Strong technical background to analytical equipment troubleshooting.
- Excellent interpersonal and communication (written and verbal) skills.
- Ability to write and review protocols, reports and other document with great attention to detail.
- Ability to work independently within prescribed guidelines, or as a team member.
- Strong critical thinking and trouble solving skills.
- Ability to multitask and produce quality results under tight timelines with sound documentation.
- Working knowledge of:
- statistical tools for data analysis
- enzymatic assays
- analytical instrumentation such as HPLC, GC, Karl Fischer, Loss on Drying and UV-Vis.
The position comes with a competitive compensation and benefits package, including paid company holidays, paid time off, health benefits, 401k match, and much more. For more information about our plans for the future, and to be considered for this career opportunity, please visit www.codexis.com.