Codexis

Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health.. The Associate Director of Quality Control is responsible to lead all lab operations of GMP Quality Control to ensure Codexis's production operations meet regulatory standards with respect to quality, integrity and efficiency.. Represent QC in cross-functional teams (Analytical Development, QA, Manufacturing, Product Management, Supply Chain departments) to meet product release timeline and manage stability programs to ensure timely testing, real time trending and generation of stability reports.. Lead, approve and provide oversight for QC GMP Quality Management Systems, including but not limited to Lab Investigation, OOS/OOTs, deviations, CAPAs and change controls.. Working knowledge of instrumentation and analytical methods for biocatalyst and oligonucleotide characterization, such as enzymatic assays, ELISA, HPLC, LC/MS, GC, Karl Fischer, UV-Vis, qPCR, CE-SDS and electrophoresis.

director of quality control

Department: 64 - QC & Analytical Development Employment Type: Full Time Location: Redwood City, CA Description Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a Associate Director of Quality Control. Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. Codexis enzymes solve for real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis™ platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. Codexis enzymes can drive improvements, such as higher yields, reduced energy usage and waste generation, improve efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications. To meet the goals we’ve set for ourselves, we look for individuals who are driven, eager to grow and ready to embrace meaningful challenges. We empower employees to be authentic, ambitious, agile and have the courage to take action where they can make a positive impact. Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health. About the Opportunity: The Associate Director of Quality Control is responsible to lead all lab operations of GMP Quality Control to ensure Codexis's production operations meet regulatory standards with respect to quality, integrity and efficiency. This position will have the opportunity to develop a growing team and provide input towards establishing GMP QC strategy in support of various stages of GMP products and programs and will be based in Redwood City, CA. If any of the below describes you, we would love to meet you! <ul><li> Leadership/Management exposure</li><li> Problem-solving capabilities</li><li> Strong Communication - both written and oral</li><li> Time management </li></ul>In this role you will be responsible for: <ul><li>Manage, coach, and develop a high performing team for all QC GMP operations to meet the quality, integrity and efficiency standards for drug development phases. </li><li>Oversee and responsible for GMP QC product release testing and stability programs. Represent QC in cross-functional teams (Analytical Development, QA, Manufacturing, Product Management, Supply Chain departments) to meet product release timeline and manage stability programs to ensure timely testing, real time trending and generation of stability reports. </li><li>Identify, oversee and manage contract testing laboratories to meet testing needs. </li><li>Lead, approve and provide oversight for QC GMP Quality Management Systems, including but not limited to Lab Investigation, OOS/OOTs, deviations, CAPAs and change controls. Author requisite documentation for quality events as needed. </li><li>Lead and drive activities related to GMP method validation and method transfer. Draft and develop QC related SOPs, protocols, reports, and regulatory sections. Perform data and notebook review and approval for product release as needed. </li><li>Lead QC teams to troubleshoot issues, and drive to completion opportunities for continuous improvement in QC operations. </li><li>Lead the activities to establish equipment/instrument qualification and validation program to meet the quality standards for the products at various drug development phases. </li></ul>The essential requirements of the job include: <ul><li>BS or MS in Analytical Chemistry, Biochemistry or Biological Sciences or equivalent with 12+ BS degree OR 10+ for MS degree years of industrial Quality Control GMP pharmaceutical environment. </li><li>Direct QC GMP operational experience at various clinical stages of drug development. </li><li>10+ years of GMP QC management experience </li><li>Strong working knowledge of FDA/EU/ICH regulations and guidance related to critical quality attributes, release testing, analytical validation and transfer, and stability testing. </li><li>Working knowledge of instrumentation and analytical methods for biocatalyst and oligonucleotide characterization, such as enzymatic assays, ELISA, HPLC, LC/MS, GC, Karl Fischer, UV-Vis, qPCR, CE-SDS and electrophoresis. </li></ul>Additional experience that would be valuable for this role includes: <ul><li>Develop and build QC testing laboratory from the ground up. </li><li>Validation experience with Enterprise Laboratory Information Management System (LIMS), Electronic Lab Notebook system (ELN), or enterprise laboratory data backup system. </li><li>Ability to assess situations within broadly defined practices and procedures to determine appropriate actions. </li></ul>CODEXIS PAY TRANSPARENCY: The anticipated salary range for candidates who will work in Redwood City is $175,000 to $220,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Codexis is a multi-state employer, and this salary range may not reflect positions that work in other states . What can Codexis offer you? <ul><li>Medical, Dental and Vision Insurance </li><li>Basic Life, AD&D, Short- and Long-Term Disability Insurance </li><li>401k with Company Match up to 4% </li><li>Company Equity </li><li>Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time </li><li>Annual Lifestyle Account for reimbursement of fitness programs, equipment and more </li><li>Employee Stock Purchase Program (ESPP) </li><li>Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)</li><li>Student Debt Program (Company Contribution to Loans)</li><li>Mental Health Wellness Program</li><li>Subsidized onsite lunch program</li><li>Onsite Gym Facilities</li><li>Paid Parental Leave</li><li>And More!</li></ul>

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