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Senior Manager CMC and Supply Chain

Employer
Cadence Health Inc.
Location
Oakland, CA
Start date
Jun 27, 2019

Progressive Women’s Health Pharmaceutical company focused on bringing wider and easier access to basic women’s health care products is seeking a Sr Manager of CMC and Supply Chain with the ability to multi-task, work well in a fluidly changing work environment.  

Essential Functions:

  • Support and manage the external analytical technical support activities for analyses of investigational and commercial drug substances and drug products.
  • Review documentation for protocols, qualifications, validations, and methods.  
  • Work jointly with Quality to manage change control for all CMO product development & analytical methods activities.
  • Provide technical writing support for all activities related to review and revision of procedures, specifications, analytical development qualification documentation, and supporting regulatory filing documents.
  • Relationship management of Cadene's contract service partners 
  • Support and manage clinical and commercial supply chain activities related to clinical trials, 3PL setup, serialization validation, state licensing, distribution.
  • Business travel may be required up to 25% (Person in plant and audit support)
  • Other duties as assigned.

Preferred Experience:

  • 10-15 years of experience working at increasing levels of responsibility in the development and commercialization of pharmaceuticals (Solid dosage experience a plus)
  • Working knowledge of 21 CFR Parts, 11, 210, 211, 820; ICH and European regulations.
  • Computer proficiency in Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat Pro, and electronic database systems.

Preferred Education:

  • Must have a Bachelor of Science degree in scientific discipline or equivalent.
  • A Postgraduate degree is a plus.

Preferred Additional Skills:

  • Motivated with a willingness to learn skills outside of direct responsibilities
  • Strong organization skills and attention to details.
  • Strong oral and communication skills.
  • Strong commitment to values of integrity, accountability, transparency, and drive.

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