Director of Pharmaceutical Chemistry, Manufacturing, & Controls (CMC)
Cadence is a mission-driven retail pharma start-up who is leading the effort to switch the birth control pill over-the-counter (OTC), in order to create easy and affordable access to contraceptives nationwide. Learn more at www.liberatethepill.com
This position is a broad role in a small, growing company and seeks to provide leadership in contract manufacturing organization (CMO) management providing technical oversight for all aspects of manufacturing. The candidate should have broad expertise and experience in pharmaceutical science, process chemistry, micronization, and analytical chemistry. In particular, the candidate should be able to demonstrate extensive problem-solving skills in the support of small molecule manufacturing of API, API micronization, drug product unit operations, analytical testing, and packaging and labelling.
The position will serve to provide leadership in the scale-up and commercial launch of a pipeline as it relates to the switch from a prescription (RX) to an over-the-counter (OTC) medicines. The candidate should have extensive experience in the understanding of chemical properties of various API’s and their compatibility with existing and novel excipients as they relate to solid oral drug delivery. The candidate should also have demonstrated ability in leading analytical methods, drug substance, and drug product process validation campaigns in preparation for commercial launch. Experience in creating scale-up and commercial production plans a plus.
· Lead all aspects of pipeline manufacturing, including API batch production, raw material sourcing, micronization and formulation optimization, analytical methods validation, methods transfer, scale-up, packaging, stability studies, management and distribution of clinical supplies, and preparing CMC sections for regulatory filings.
· Provide leadership for activities supporting commercial launch, including serving as person-in-plant (PIP).
· Oversee primary and secondary packaging and labelling operations ensuring marketing needs are addressed adequately in support of launch.
· Author, review, and/or approve analytical methods, protocols, validation reports, and release and stability data, providing support for trouble shooting and continuous improvement.
· Develop program management systems for the efficient management and review of projects, and provide/develop project tracking reports. In collaboration with management, develop and manage annual CMC goals, budgets and performance.
· Ensure manufacturing strategies, budget and timelines are consistent with scale-up/commercialization plans and goals.
· Establish secondary source, when appropriate, for API and other key raw materials.
· Author key sections of regulatory filings to support OTC launch in the US.
· Other projects when assigned
BS/MS/PhD degree in Chemistry, Life Sciences or related disciplines, BS/MS in Chemical Engineering/Pharmaceutical Science/Biochemistry.
12-15+ years of pharma/biotech industry experience primarily in pharmaceutical manufacturing, particularly in solid-oral drug delivery. Understanding the regulatory/product development path of the conversion of prescription to over-the-counter medicines a plus.