DESCRIPTION

Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a Associate Director, ECO Process Development.
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:

We are seeking an experienced and innovative Associate Director of Process Development to lead efforts in the development and optimization of enzymatic manufacturing processes for small interfering RNA (siRNA) therapeutics using Codexis ECO Synthesis™ technology. The ideal candidate will have a strong background in nucleic acid chemistry, enzymatic synthesis, and process scale-up, with proven experience leading cross-functional teams in a fast-paced, development-stage biotech or pharmaceutical environment.

If any of the below describes you, we would love to meet you!

• Possess a passion for being part of the therapeutic community helping bring cutting edge treatments to patients in need.
• Enjoys collaboration across different functional groups to get a holistic understanding of process development along with aligning data with internal stakeholders.
• Finds fulfillment in problem solving by implementing process and engineering and solutions.

THE ESSENTIAL REQUIREMENTS OF THE JOB INCLUDE:

• Ph.D. in Biochemistry, Molecular Biology, Chemical Engineering, Pharmaceutical Sciences, or related field; or M.S. with significant relevant experience.
• 8+ years of experience in process development for oligonucleotides, preferably with direct expertise in siRNA and enzymatic synthesis (e.g., T7 transcription, ligation, nuclease digestion, etc.).
• Demonstrated success in scaling up enzymatic processes for clinical or commercial manufacturing.
• Deep understanding of regulatory expectations for nucleic acid-based therapeutics (CMC, ICH guidelines, etc.).
• Strong leadership and team management skills; experience mentoring junior scientists and leading cross-functional projects.
• Excellent written and oral communication skills, including experience with regulatory documentation and presentations to senior leadership.
• Strong written and verbal communication skills, with the ability to clearly convey scientific finds to cross functional teams.

IN THIS ROLE YOU WILL BE RESPONSIBLE FOR:

• Leading the development of robust, scalable, and cost-effective enzymatic processes for the synthesis and modification of siRNA therapeutics.
• Direct enzyme selection, engineering, and optimization strategies to improve yield, specificity, and purity of siRNA products.
• Collaborate with Attribute Sciences to define critical quality attributes (CQAs) and ensure appropriate in-process and release testing.
• Drive technology transfer from lab-scale to pilot- and GMP-scale manufacturing, including authoring of tech transfer documentation and batch records.
• Serve as a technical subject matter expert (SME) in regulatory filings (e.g., IND, IMPD, BLA), providing content for CMC sections as needed.
• Oversee external manufacturing partners (CDMOs), providing technical guidance, reviewing protocols, and supporting troubleshooting activities.
• Manage and mentor a team of scientists and associates; foster a collaborative, data-driven, and innovation-focused culture.
• Evaluate and implement emerging technologies, tools, and automation relevant to siRNA and enzyme-based synthesis platforms.
• Develop project timelines, resource planning, and risk assessments in collaboration with Program Management and other functional leads.

ADDITIONAL EXPERIENCE THAT WOULD BE VALUABLE FOR THIS ROLE INCLUDES:

• Prior experience working with or within CDMOs.
• Knowledge of Quality by Design (QbD), Design of Experiments (DoE), and statistical analysis tools.
  CODEXIS PAY TRANSPARENCY: The anticipated salary range for candidates who will work in Redwood City is $175,000 to $197,000. 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.