Director of Manufacturing and Technical Operations
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
Cadence is a mission-driven retail pharma start-up leading the effort to switch one or more birth control pills to over-the-counter (OTC) status. The mission of the company is to enable easy and affordable access to oral contraceptives nationwide. Learn more at www.liberatethepill.com
The scope of responsibilities for this role are broad, commensurate with a start up in the pharma space. The successful candidate will:
- manage contract manufacturing organizations (CMOs)
- oversee all operational and technical aspects of clinical and commercial manufacturing
- contribute to CMC sections of all regulatory filings in the US and abroad
The Cadence products are FDA approved Rx oral contraceptives containing ethinyl estradiol, progestins and placebo reminder pills in tablet form and dispensed in blister packs. The products were not being actively manufactured when acquired.
The role will:
- Lead all aspects of pipeline manufacturing as needed, including API batch production, raw material sourcing, micronization and formulation optimization, , , technical/knowledge transfer of manufacturing and scale-up, packaging, labeling, management and distribution of clinical supplies.
- Provide leadership for activities supporting commercial launch, including serving as person-in-plant (PIP). Participate as needed in PAI activities and GMP inspections.
- Develop program management systems for the efficient management and review of CMC projects, and provide/develop project tracking reports. In collaboration with management, develop and manage annual CMC goals, budgets and performance.
- Oversee primary and secondary packaging and labelling operations ensuring marketing needs are addressed adequately in support of launch. Identify supply chain for effective storage and continuous distribution of products.
- Author, review, and/or approve =manufacturing validation protocols and validation reports, supply agreements, and quality agreements.
- Participate and lead manufacturing investigations related to out of specification results and/or technical challenges.
- Monitor manufacturing effectiveness and generate control chart to identify efficiencies for continuous improvement initiatives.
- Author and review key CMC sections of regulatory filings to support global approvals.
- Ensure manufacturing strategies, budget and timelines are consistent with scale-up/commercialization plans and goals.
- Establish secondary sources, for API and other key raw materials, as well as drug product manufacture.
- Develop Risk Management Plans and conduct Risk Assessments as needed.
- Develop and implement QbD as appropriate.
Position reports to COO
BS/MS/PhD degree in Chemistry, Life Sciences or related disciplines, or BS/MS in Chemical Engineering/Pharmaceutical Science/Biochemistry.
Successful candidates will have demonstrated ability to oversee, global technical operations activities for the development and manufacture of drug product commercial launch and routine manufacture. Experience in creating global scale-up and commercial production plans a plus.
12-15+ years pharma/biotech industry experience including pharmaceutical manufacturing, and solid-oral drug delivery. Understanding of the regulatory/product development requirements to support approval, launch and commercial supply.