Senior Manager Cmc And Supply Chain
43268 Senior Manager CMC and Supply Chain
Senior Manager CMC and Supply Chain
Cadence Health Inc.
Jun 27, 2019
Manufacturing & Production, Materials/Inventory Control, Operations, Process, Supply Chain, Science/R&D, Biotechnology
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Progressive Womens Health Pharmaceutical company focused on bringing wider and easier access to basic womens 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.
* 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.
* 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.
* 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.
supply chain, inventory control, 3pl, supplies, microsoft office, microsoft excel, microsoft word, microsoft powerpoint, healthcare, manufacturing, product development, communication, microsoft access, auditing, organization