Senior Leader Manufacturing and Technical Operations

Senior Leader Manufacturing and Technical Operations

Cadence Health is a small, private consumer healthcare company located in the San Francisco Bay Area (Oakland) looking for a manufacturing expert to join our leadership team.  Cadence is a mission-driven start-up leading an effort to move birth control pills to over-the-counter (OTC) status.  We own two popular FDA-approved Rx oral contraceptives.  Our goal is to enable easy and affordable access to our pills nationwide and eventually internationally.  We also plan to expand our product portfolio with other OTC women’s health products. Cadence is currently in stealth mode, so we do not have a company website.  

The arrangement for this position can be flexible – could be remote from anywhere in the US, and could be part-time, full-time, consulting or employee; our focus is to identify someone with the best profile to thrive in this important role.

The scope of responsibilities for this role are broad, commensurate with a start up in the pharma space.  The successful candidate will:

  • manage a small internal team and contract manufacturing organizations (CMOs)
  • oversee all operational and technical aspects of clinical and commercial manufacturing, packaging, testing and distribution of Cadence products
  • contribute to CMC sections of all regulatory filings in the US and abroad

Background:

The Cadence current products are FDA approved Rx oral contraceptives containing ethinyl estradiol, progestins and placebo reminder pills in tablet form and packaged in blister packs.  We are also investigating pipeline products in the OTC women’s health categories.

Job Descriptions:

  • Develop manufacturing commercialization strategies; ensure that resources, budget and timelines are consistent with commercialization plans and goals.
  • Lead all aspects of pipeline manufacturing of clinical and commercial drug products with CMOs, including analytical method development/validation, drug substance and raw material sourcing, micronization and formulation optimization, technical/knowledge transfer of manufacturing and scale-up, drug product production, packaging, labeling, management and distribution.
  • Participate as needed in vendor audits and regulatory inspections
  • Develop program management systems for the efficient management and review of CMC projects, and provide/develop project tracking reports. In collaboration with Senior 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 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.
  • Establish secondary sources, for drug substances and other key raw materials, as well as a second drug product manufacturer.
  • Develop Risk Management Plans and conduct Risk Assessments as needed.
  • Develop and implement QbD as appropriate.
  • Help assess potential future products.

Basic Qualifications:

BS/MS/PhD degree in Chemistry or related disciplines, or BS/MS in Chemical Engineering/Pharmaceutical Science/Biochemistry.

Experience:

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. Ideal experience includes technology transfer to CMOs, analytical method development/validation, and global scale-up and commercial production.

Preferred Qualifications:

At minimum, 15 years of pharma/biotech industry experience including pharmaceutical manufacturing, and solid-oral drug delivery. Understanding of regulatory/product development requirements to support approval, launch and commercial supply.