Head of Control Innovation and Technology Director
Citi
Associate Director, ECO Process Development
Codexis, Inc.
full-time
Posted on:
Location: California • 🇺🇸 United States
Visit company websiteSalary
💰 $175,000 - $197,000 per year
Job Level
Senior
About the role
- Lead 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.
Requirements
- 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.
- Prior experience working with or within CDMOs (valuable).
- Knowledge of Quality by Design (QbD), Design of Experiments (DoE), and statistical analysis tools (valuable).
- Strong background in nucleic acid chemistry, enzymatic synthesis, and process scale-up.
