Vapogenix: Director of Pharmaceutical CMC

Vapogenix is a clinical-stage pharmaceutical company developing a novel class of topical non-opioid analgesics. Our technology is exciting and has the potential to transform the lives of millions of patients suffering from pain by providing safer and more effective therapeutic options. We are looking for an experienced, team-oriented CMC leader to join us.

Job description

The Director will be responsible for the strategic and operational leadership of all CMC aspects of Vapogenix’s portfolio. The Director will be part of the Vapogenix Leadership Management Team and contribute to all aspects of the drug development programs and to overall company strategy.

Key Responsibilities

  • Develop and execute comprehensive strategies for drug product development and manufacture, from preclinical activities through Phase 3 registration studies
  • Identify, select, and manage Contract Manufacturing Organizations (CMOs) for the outsourcing of manufacturing activities and drug packaging solutions for development programs; includes management oversight of formulation development activities, starting materials, drug products and packaging.
  • Manage development and clinical supply chain logistics
  • Develop appropriate commercial product packaging
  • Ensure development of appropriate analytical methods, validations, and specifications compliant with all relevant regulatory requirements
  • Review manufacturing batch records, validation reports, technical development reports and other CMC documents
  • Write and review CMC sections of regulatory documents and grant submissions
  • Support patent prosecution

Qualifications:

  • Minimum MS in Chemistry or related scientific discipline is required
  • PhD desirable

Experience and skills:

  • Minimum 10 years of CMC/GMP experience in the pharmaceutical industry with progressively increasing levels of responsibility
  • Track record of successful management of CMOs to ensure appropriate solutions to CMC challenges and on-time delivery of clinical supplies
  • Excellent management skills including leading cross-functional CMC teams to accomplish drug development and manufacturing goals
  • Experience in overseeing contract manufacturing and other third-party client relationships
  • In depth knowledge of and experience working in a GMP-regulated environment within the pharmaceutical industry, preferably in small molecule drug product development, manufacturing, or relevant operations role
  • Experience in establishing product specifications and overseeing the development of supporting analytical processes
  • Experience with technology transfer of manufacturing processes
  • Experience with negotiating effective technical proposals and agreements with CMOs
  • Ability to work flexibly and collaboratively with internal and external individuals and teams
  • Topical product development experience highly desirable
  • Knowledge of developing volatile drug substances desirable
  • Knowledge of topical patch technology desirable

Contact: jobs@vapogenix.com

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