Senior Manager CMC and Supply Chain
- Employer
- Cadence Health Inc.
- Location
- Oakland, CA
- Start date
- Jun 27, 2019
View more
- Discipline
- Manufacturing & Production, Materials/Inventory Control, Operations, Process, Supply Chain, Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
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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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