Sr Manager/Assoc Dir CMC and Supply Chain - Oakland, California, United States, 94612
This position will support CMC and Supply Chain function within Cadence Health, Inc.
- 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.
- 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.
- 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