Overview

Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a Director of Quality Assurance.

Location: Redwood City, CA. Workplace: Onsite. This is a full-time position.

About Codexis

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 real-world challenges in small molecule pharmaceutical manufacturing and nucleic acid synthesis. The Company is developing its ECO Synthesis platform to enable scaled manufacture of RNAi therapeutics through an enzymatic route.

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 batches, development/creation of quality systems and internal audits. This role will be based in Redwood City, CA.

Responsibilities

• 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 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 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.

Essential Requirements

• 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

• Technical experience or understanding in fermentation/DSP and quality control.
• Experience assessing whether products meet specifications and determining disposition of products.
• Experience building efficient quality systems.

Compensation and Benefits

Codexis Pay Transparency: The anticipated salary range for candidates who will work in Redwood City is $210,000 to $256,000. The final salary offered will depend on experience and other factors. Benefits include:

• Medical, Dental and Vision Insurance
• Life, AD&D, Short- and Long-Term Disability Insurance
• 401k with Company Match up to 4%
• Company Equity
• Generous Paid Time Off, holidays, and wellness time
• Employee Stock Purchase Program (ESPP)
• Flexible Spending Accounts
• Other programs and perks

Equal Opportunity

Codexis is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status and veteran status.