The Director of Process Chemistry is a member of the Preclinical Development team working to translate Kallyope’s cutting-edge biology on the gut and gut-brain axis to transformational therapeutics. Reporting to the Head of Process Chemistry, candidates must be highly motivated with significant experience in scale-up of API, from discovery to the clinic, and managing external partners. Successful candidates must be able to work effectively in a collaborative setting with the related cross-functional teams to support drug discovery, IND-enabling studies, CMC IND/IMPD and NDA/MAA filings, and GMP API manufacturing and supply.
- Contribute to the process chemistry efforts in facilitating medicinal chemistry research by overcoming synthetic bottlenecks to chemical intermediates and active pharmaceutical ingredients (API) and streamlining SAR
- Accountable for new route design and development/implementation of phase appropriate and robust synthetic processes to successfully deliver preclinical and clinical API batches
- Responsible for all activities related to process development and validation for our programs in the clinical and commercialization stages
- Perform vendor / CMO review and selection in addition to the management of process development and manufacturing activities at CMOs
- Work closely with regulatory affairs to author CMC sections in the IND/IMPD and NDA/MAA filings
- Participate in proactive resource planning, contract/agreement negotiations, and budget management
- Represent CMC in the core and sub-functional teams; responsible for strategic planning, risk-assessment, timeline tracking, and implementation in pre-clinical and clinical stages
QUALIFICATIONS AND EDUCATION REQUIREMENTS
- Ph.D. in organic chemistry or related discipline or equivalent industrial experience
- Prior experience (7+ years) of drug discovery/development experience and demonstrated ability in leading cross-functional groups
- Experience in late-phase process development (Registration and Validation Campaigns) and knowledge of NDA fillings is desirable, but not required.
- Strong subject matter expertise in process development, solid state characterization, cGMP manufacturing, and CMO management
- Exceptional problem-solving skills and ability to quickly adapt and shift focus as needed
- Excellent interpersonal, communication, and collaboration skills
- Demonstrated ability in strategic planning and prioritization of a portfolio of projects
- Ability to multi-task in a fast-paced dynamic environment while demonstrating a calm and positive attitude and a superior work ethic
Kallyope is a new biotechnology company headquartered in New York City. Founded by Richard Axel, Tom Maniatis, and Charles Zuker from Columbia University, Kallyope is focused on the identification of new therapeutic and nutritional opportunities involving the gut and gut-brain axis. The Company leverages the founders’ formidable expertise in molecular biology, neuroscience, and behavior to identify new approaches to human health.
Kallyope is seeking creative, highly motivated individuals who are interested in working in a biotech environment that is scientifically stimulating, highly collaborative, and laser focused on translational biology. The Company is creating an industry-leading platform employing cutting edge technologies including sequencing, genetics, circuit mapping, neural imaging and bioinformatics. By integrating and applying complementary tools and approaches to the understanding of gut and gut-brain biology, Kallyope aims to develop transformational therapeutics and consumer products to improve human health and nutrition.
The Company is headquartered in the Alexandria Center® for Life Sciences, a state-of-the-art, collaborative life science campus in the heart of Manhattan, with close proximity to New York City’s world-leading clinical and research institutions. Kallyope has raised $252M in funding from several top-tier investors. The Company has assembled a leadership team and advisory group with a proven track record of success and strong expertise in drug discovery and translation. The founding scientific team is composed of highly creative and talented individuals with outstanding expertise in the Company’s core platform technologies. For more information, see www.kallyope.com.