62 - Bio TX Dev CMC
Redwood City, CA
Codexis, a biotech company based in Redwood City, CA, is looking to hire a Director, Tech Ops.
Codexis is a leading enzyme engineering company leveraging our proprietary CodeEvolver® technology platform to discover and develop novel, high performance enzymes for three healthcare industry pillars: pharmaceutical manufacturing, life sciences, and biotherapeutic discovery & development
. The enzymes we produce aim to solve real-world challenges associated with small molecule pharmaceuticals manufacturing, nucleic acid synthesis and genomic sequencing, and - as biotherapeutic candidates - they have the potential to treat challenging diseases.
To meet this goal, 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. Whether you are driven by science, or a different area of expertise, we need you to help us create a brighter future.
Come join us on this journey and mission of making the world a safer, healthier, and better place!
About the Opportunity:
The Director, Tech Ops will initially be responsible for the leading a multidisciplinary team to successful GMP manufacturing of a biological drug substance to support Phase III and commercial for a key Codexis enzyme replacement therapy program. The candidate will work closely with analytical development, quality, regulatory, process development and operational functions to drive the programs to success. This position is based in San Carlos, California and requires a minimum of three days onsite each week. If any of the below describes you, we would love to meet you!
- Organized approach to work with a proactive mindset to identify gaps and provide solutions.
- Leadership through attention to project detail with strong analytical and problem-solving skills.
- Strong verbal and written communication skills.
- Dedication to driving high impact biopharmaceutical programs to major milestones.
- Able to travel domestically and internationally a few times per year.
In this role you will be responsible for:
- Leading a multidisciplinary team to develop and manufacture bulk drug substance.
- Lead the CDMO selection process for protein drug substance development and manufacturing to support Phase III and commercial.
- Lead CMC activities including USP/DSP gap analysis, scale up, formulation and process optimization, and process characterization.
- Protein drug substance GMP production and release at large scale (>10,000 L) to supply drug product manufacturing for Phase III and commercial.
- Designing, executing, organizing and review of drug substance related production, analytical and stability information/data to meet regulatory IND and BLA filing requirements.
- Tech Ops lead for other preclinical projects as required.
The essential requirements of the job include: Preferably a PhD (minimum MSc degree) with 10 years of relevant industry experience is required.
o CDMO selection processes including intelligence gathering, RFP preparation, proposal review and contract negotiation.o CDMO management and oversight to meet project timelines and successful biologics GMP production. o Microbial fermentation and recombinant protein downstream purification processes including risk-based DOE, QbD and control strategy design.o Leading multi-functional teams including Research, AD, QC, QA and Regulatory to execute against aggressive timelines.
Additional experience that would be valuable for this role includes:
· Experience with ICH guidelines and late stage (beyond Phase II) biologics programs · Experience with project budget forecasting and monitoring· Experience with Microsoft Word, Excel, Project, Teams and SharePoint.
CODEXIS PAY TRANSPARENCY: The anticipated salary range for candidates who will work in Redwood City or San Carlos, California City is $190,000 to $248,000. 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?
- Full benefits on your first day
- 100% match on 401k (up to 4%)
- Life insurance 3x your salary
- Company equity program – stock and RSU’s offered for new hires and annually
- Generous PTO
- 15 company paid holidays in addition to PTO
- Fitness reimbursement
- Back up child/dependent care
- Commuter vouchers
- Student loan assistance and student debt program
- Schedule that works for you as we support an onsite, hybrid and remote workforce for certain positions
- Internal mobility
- Volunteer time off
- Health and wellness programs
- Legal and tax support program
About Codexis Inc
Why join Codexis?
At Codexis we offer a very competitive compensation package and beyond excellent benefits! We foster career growth, continued education and upskilling through our mentorship program and learning and development opportunities. You will learn and work alongside inspirational leaders and colleagues who are equally passionate about our mission and committed to fostering an inclusive, growth-centered, and rewarding culture. Diversity is valued and mutual trust is of paramount importance to the ethos at Codexis. The people, the culture and working with others with a common goal is what makes Codexis a great place to work.
For more information, visit www.codexis.com
NO AGENCIES OR THIRD PARTIES
Codexis is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.