Codexis, Inc.
Director of Quality Assurance
Codexis, Inc., California, Missouri, United States, 65018
Director of Quality Assurance
Department:
64 - QC & Analytical DevelopmentEmployment Type:
Full TimeLocation:
Redwood City, CA
Description
Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a
Director of Quality Assurance.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 Director of Quality Assurance is responsible for quality functions including disposition of enzymes, deviation resolution, CAPAs, change control, lab investigations, documentation supporting the suitability of the batches, completion of customer questionnaires, development/creation of quality systems and internal audits. This role will be based in Redwood City, CA.If any of the below describes you, we would love to meet you!
Attention to detail with accuracy and thoroughness in all aspects.Adaptable, highly accountable and able to prioritize effectively.Excellent communication (verbal and e-mail), interpersonal and organizational skills.Ability to manage QA staff and projects (direct and indirect) and variable workloads to timelines.In this role you will be responsible for:
Product disposition and QA support for the manufacture and testing of Codexis products. Work directly with internal operational groups to ensure that products meet all required quality standards, specifications and requirements.Provide QA leadership and collaborate with Supply Chain, Manufacturing, Quality Control, Analytical Development and Regulatory to ensure that internal operations achieve and maintain compliance with Codexis quality standards.Develop, establish, and maintain internal quality systems and processes.Technical review of deviations, investigations, change control, CAPAs and reports/memos.Write, review, and approve SOPs and various other documents for consistency with quality principles and existing quality systems.Coordinate and facilitate with CMOs to achieve quality objectives and resolution of quality issues.Lead internal audit program and prepare for and host customer quality audits.The essential requirements of the job include:
BA or BS degree in a scientific discipline; advanced degree in sciences preferred.A minimum of 15 years of experience in Quality Assurance Management supporting manufacturing and quality control in a pharmaceutical or biotech environment.In-depth knowledge and application of GMP and ICH Guidelines.Additional experience that would be valuable for this role includes:
Technical experience or understanding in fermentation/DSP and quality control.Previous responsibility for assessing whether products meet specifications, required quality standards and determining disposition of products.Previous experience building efficient quality systems.CODEXIS PAY TRANSPARENCY:
The anticipated salary range for candidates who will work in Redwood City is $195,000 to $244,000. 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?
Medical, Dental and Vision InsuranceBasic Life, AD&D, Short- and Long-Term Disability Insurance401k with Company Match up to 4%Company EquityGenerous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness TimeAnnual Lifestyle Account for reimbursement of fitness programs, equipment and moreEmployee Stock Purchase Program (ESPP)Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)Student Debt Program (Company Contribution to Loans)Mental Health Wellness ProgramSubsidized onsite lunch programOnsite Gym FacilitiesPaid Parental LeaveAnd More!
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Department:
64 - QC & Analytical DevelopmentEmployment Type:
Full TimeLocation:
Redwood City, CA
Description
Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a
Director of Quality Assurance.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 Director of Quality Assurance is responsible for quality functions including disposition of enzymes, deviation resolution, CAPAs, change control, lab investigations, documentation supporting the suitability of the batches, completion of customer questionnaires, development/creation of quality systems and internal audits. This role will be based in Redwood City, CA.If any of the below describes you, we would love to meet you!
Attention to detail with accuracy and thoroughness in all aspects.Adaptable, highly accountable and able to prioritize effectively.Excellent communication (verbal and e-mail), interpersonal and organizational skills.Ability to manage QA staff and projects (direct and indirect) and variable workloads to timelines.In this role you will be responsible for:
Product disposition and QA support for the manufacture and testing of Codexis products. Work directly with internal operational groups to ensure that products meet all required quality standards, specifications and requirements.Provide QA leadership and collaborate with Supply Chain, Manufacturing, Quality Control, Analytical Development and Regulatory to ensure that internal operations achieve and maintain compliance with Codexis quality standards.Develop, establish, and maintain internal quality systems and processes.Technical review of deviations, investigations, change control, CAPAs and reports/memos.Write, review, and approve SOPs and various other documents for consistency with quality principles and existing quality systems.Coordinate and facilitate with CMOs to achieve quality objectives and resolution of quality issues.Lead internal audit program and prepare for and host customer quality audits.The essential requirements of the job include:
BA or BS degree in a scientific discipline; advanced degree in sciences preferred.A minimum of 15 years of experience in Quality Assurance Management supporting manufacturing and quality control in a pharmaceutical or biotech environment.In-depth knowledge and application of GMP and ICH Guidelines.Additional experience that would be valuable for this role includes:
Technical experience or understanding in fermentation/DSP and quality control.Previous responsibility for assessing whether products meet specifications, required quality standards and determining disposition of products.Previous experience building efficient quality systems.CODEXIS PAY TRANSPARENCY:
The anticipated salary range for candidates who will work in Redwood City is $195,000 to $244,000. 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?
Medical, Dental and Vision InsuranceBasic Life, AD&D, Short- and Long-Term Disability Insurance401k with Company Match up to 4%Company EquityGenerous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness TimeAnnual Lifestyle Account for reimbursement of fitness programs, equipment and moreEmployee Stock Purchase Program (ESPP)Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)Student Debt Program (Company Contribution to Loans)Mental Health Wellness ProgramSubsidized onsite lunch programOnsite Gym FacilitiesPaid Parental LeaveAnd More!
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