Finding a good job is very good.

Finding a good job in a dynamic, growing company is great.

Finding a great job in a world-changing organization is a once-in-a-lifetime opportunity.

Welcome to Proteus Digital Health, where we’re pioneering a new category of products, services and data systems based on ingestible computing. Our core technology – the digital health feedback system – provides an unprecedented view into an individual’s personal health choices and physiologic response. This care-altering feedback system enables patients to better manage their health, allows more effective collaboration with caregivers and clinicians, all while enabling new information-based business models.

What Amazon did with books, and Apple did with music, Proteus is poised to do with digital medicine. Come join our unique collection of innovative scientists, engineers, market makers, designers, doctors, developers, clinicians, and other digital health industry pioneers, and help us dramatically improve the lives of tens of millions across the globe.

Learn more about what we do (video): https://proteus.app.box.com/BuildersandInnovators

Job Title: CMC Program Manager

Team: Program Management

Reports To: Head of Program Management

The energy and culture at Proteus is a contagious mix of passion, focus, relentless determination, and serious fun. Proteans are mission-minded and collaborate in a way that’s refreshingly encouraging. With all of this comes success and then growth, which is why you’re reading this now because we are seeking an experienced CMC Program Manager.  But it doesn’t end there. Here’s a summary of this great opportunity:

Proteus is seeking a CMC Program Manager with strong knowledge of the overall drug development process. This person will support the Digital Medicine program from feasibility to IND and NDA submissions. This person will work closely with Regulatory, Clinical, Quality, R&D, and Operations to develop and execute project plans to meet company goals.

· Gathers project requirements, and develops scope, schedule, and budget

· Identifies and secures resources

· Leads cross functional product development team to meet project goals

· Supports and maintains project documentation

· Leads and facilitates meetings including setting clear agendas, documenting minutes, decisions, and action items

· Manages Contract Development and Manufacturing Organizations (CDMOs)

· Develops and publishes communications, including project status and reports

· Develops and documents high level strategies for accomplishing project objectives

· Leads team to identify risks, develop mitigation and contingency plans

· Manages projects within established scope, schedule, and budget

· Minimum Bachelor’s degree in Science or Engineering

· 5-7 years of product development experience in CMC pharmaceuticals (preferably solid oral dose forms) and/or drug device combination products

· At least 5 years of experience managing cross functional R&D/product development projects/programs in the pharmaceutical or drug/device industries

· Experience in managing IND and NDA submissions

· Practical knowledge of Pharmaceutical product development and cGMP requirements

· Knowledge of global standards and regulations for drug device combination products including ISO13485, 21CRF820, 210, 211

· Understanding of pharmaceutical bioequivalence and ICH stability testing

· Experience managing external project support such as Contract Development and Manufacturing Organizations (CDMO)

· Technical competence with MS Word, MS Excel, MS PowerPoint, MS Visio, MS Project and Confluence

· Knowledge and application of project management process (PMP desired)

· Able to work in a fast-paced, complex, dynamic environment

· Effectively prioritize and execute tasks in a high-pressure environment

· Proven ability to lead, influence and work with cross functional team as well as with all levels in the organization

· Ability to align various points of view from different disciplines

· Exceptional interpersonal and leadership skills to effectively communicate and build relationships at all levels in the organization

· Strong work ethic, ability to multi-task, and execute sound judgment in the interest of meeting the company goals

· Solid organizational and analytical skills, and detail oriented

** This position will split time between our two locations in Redwood City and Hayward

Ready for the ride of your life? We’re looking forward to receiving your resume!

We provide our employees with a great benefits package, which includes: medical/dental/vision insurance, 401K, paid time off (PTO)—including your birthday off, employee stock options, a bright & awesomely designed physical work space, a complimentary wearable device (i.e. Fitbit), fitness centers, and, of course free snacks & beverages.

About Us: Proteus has received FDA market clearance in the U.S. and a CE mark in Europe for its wearable and ingestible sensor devices. Headquartered in Redwood City, Calif., Proteus is privately held and funded by Carlyle, Essex Woodlands, Kaiser Permanente, Medtronic, Novartis, Otsuka, Oracle, ON Semiconductor, and other investors.