Sanofi Group Head of Early CMC in La Jolla, California
As a member of the management team located in La Jolla, CA , the Head of early CMC is responsible to oversee all aspects of CMC-related activities for new targets from conception to selection of lead candidates including the development of strains, upstream and downstream processes, bioanalytical methods and formulation to support early discovery research through transition of candidates into Development.
Essential duties and responsibilities include the following. Other duties may be assigned.
Build and manage a group of Directors and Scientists to successfully meet company objectives and goals related to generation and characterization of Synthorins.
Responsible for continued platform development improving Synthorin production and alignment with late stage Development teams to implement continued improvements for better CMC development.
Responsible for producing and characterizing early research candidates using microbial systems and state of the art advanced analytical techniques, implementing phase appropriate developability strategies.
Responsible for providing scientific and collaborative leadership over internal and external contract research and manufacturing organizations for the development of strains, upstream and downstream processes, bioanalytical methods and formulation for multiple programs. Oversee technology transfer including manufacturing process and analytical methods to internal groups or external CRO/CDMOs.
Responsible for collaborating with internal partners to ensure delivery of robust, scalable and cost-effective manufacturing processes that meet or exceed target product profile.
Prepare and manage budget for the early CMC Department.
Management of supply chain.
Provide scientific rationale and direction for the appropriate execution of early research programs, through selection of lead candidate. Author and review CMC sections of IND. Represent the company as CMC expert in communications with regulatory agencies.
Develop and execute plans for platform improvements.
Provide scientific rationale and direction for the phase appropriate execution of early stage research and development for programs in alignment with different company therapeutic areas.
Cross-functional role with multiple units to ensure smooth operations among R&D, pre-clinical Pharmacology, Manufacturing and Clinical.
Investigate the feasibility of applying a wide range of scientific principles and concepts to potential inventions (strain/platform improvements and new targets for therapeutics) and/or products.
Scientific lead for the development of new programs.
Write, review and approve, as appropriate, reports and papers for the research and early stage development programs, facilitating technical transfer to external organizations.
Prepare and give presentations to multi-level audiences.
Demonstrate the ability to effectively manage research staff, collaborate with other scientific members of the team and make strong individual contributions to the project.
PhD in cell biology, biochemistry, immunology or related biomedical field, with 15+ years of post-graduate experience.
Hands-on experience in technology development.
Experience in microbial process development and CMC.
Experience managing CRO/CDMO for manufacturing of biologics.
Experience in target development for protein therapeutics, including screening, hit & lead generation, and lead optimization.
Experience coordinating all aspects involved in the discovery and pre-clinical development of biologic drugs. Experience interacting with FDA regulators.
Deep understanding of recombinant protein production, including protein chemistry and biophysics, and their application to the assessment of biologics developability & manufacturability.
Superior organizational skills, with a strong track record as coordinator of critical path activities with internal stake holders and external service providers and partners.
Experience in building and supervising group of Directors, Scientist and Associates in meeting timelines, executing lab-based experiments and data analysis and career development.
Demonstrated ability to organize and deploy best practices for data compliance through their life cycle: generation & analysis, communication and archiving; experience with data & sample management systems.
Proven track record of success in tackling non-standard problems.
Self motivated and ability to think “outside the box” to challenge existing dogmas is a must.
Hands on experience with amber suppression method a big plus.
Ability to appropriately manage and prioritize a diverse workload.
Detail oriented, yet ability to keep the big picture in mind.
Ability to work under pressure to meet deadlines and solid multitasking skills.
Excellent oral and written communication skills with the ability to clearly explain complex issues to diverse audiences.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.