Director/Sr Director Protein Formulations Development
Are you ready to join our mission to fight rare diseases? Do you have a passion to help people have better quality of life? Come be part of the Codexis, Inc. team where every day we get to unlock the power of proteins®!
Codexis’s Biotherapeutics division uses our world-leading CodeEvolver® protein engineering platform to discover novel therapies for the treatment of genetic disorders and other debilitating disease. We engineer proteins with high efficacy and safety with the goal of delivering the therapeutic to patients as an enzyme replacement, mRNA, or gene therapy.
But we can’t do it without YOU!
To help us reach our goals we are looking to hire a Director/Sr. Director Formulations Development to join our QC & Analytical Development Department.
If you can describe yourself by the statements below, we would love to engage you in conversation.
- Can establish and build formulations functionality to support multiple business units (Performance Enzymes & Biotherapeutics)
- Has comprehensive understanding of protein science with regards to physical characterization and pre-formulations
- Can work cross functionally to coordinate activities CMC, Analytical Development, Process Development & Translational Sciences
In this role you will be responsible for:
- Support project teams through scientific design and execution of formulation strategies for Codexis Biotherapeutics and Performance Enzymes assets
- Provide formulations support for process development and translational sciences
- Coordinate with Analytical Development on design and execution of physicochemical characterization and pre-formulation studies
- Maintain knowledge of emerging techniques, equipment and applicable regulations (e.g., ICH for stability, specifications, etc.)
- CRO selection and management of outsourced formulation development projects
- CMC support for selection and management of bulk drug substance and drug product manufacturing
- Drafting of applicable CMC sections of regulatory submissions
To be successful in this role, your background and experience should include:
- PhD with post-doctoral experience, preferably in protein science, pharmaceutical science or formulation development.; 10+ years of relevant industry experience
- Bulk drug substance and drug product development experience with biotherapeutic molecules essential and knowledge of enzymes desired.
- Experience in development of solid and liquid formulations, including oral dosing solutions for early phase projects.
- Demonstrated expertise in the independent design and execution of both solid and liquid protein formulation development projects
- Experience with protein characterization and protein-based analytics
- Excellent written/oral communication and presentation skills
What can Codexis offer you? (besides an amazing and collaborative culture?)
- Full benefits on your first day
- 100% match on 401k (up to 4%)
- Generous flex time off
- Fitness reimbursement
- Free fitness classes
- Back up child/dependent care
- Commuter vouchers
- Much more!
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 sta