Sr Manager/Assoc Dir CMC and Supply Chain - Oakland, California, United States, 94612

Position Summary:

This position will support CMC and Supply Chain function within Cadence Health, Inc.

Essential Functions:

  • Manage relationships and day to day interactions with contract service partners
  • Partner with Quality for person-in-plant (PIP) activities as well as supplier audits
  • Lead and manage external analytical chemistry method development/transfers
  • Provide technical support for process and lab investigations associated with drug substances and drug products.
  • Technical writing to support activities related to review and revision of procedures, specifications, analytical development qualification documentation, and CMC sections for regulatory filing packages.
  • Work jointly with Quality to manage change control for all CMO product development & analytical methods activities.
  • Support and manage clinical and commercial supply chain activities related to clinical trials, 3PL setup, serialization validation, state licensing, distribution.
  • Must be able to travel up to 25% domestically and internationally
  • other activities as assigned.

Preferred Experience:

  • Minimum of 5-10 years' experience working at increasing levels of responsibility in the development and commercialization of pharmaceuticals
  • 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:

  • Undergraduate degree in the life sciences or engineering (postgraduate degree is a plus)

Preferred Additional Skills:

  • Strong organization skills and attention to details.
  • Strong oral and communication skills.
  • Motivated with a wiliness to learn