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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: Head of Pharmaceutical Development

Team: Drug Device Combination Engineering

Reports To: Head of Digital Medicines Engineering

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 Head of Pharmaceutical Development.

In this newly created exciting role, you will lead the Digital Medicines Deployment team and be responsible for implementing solutions for encapsulated and integrated digital medicines. You will work cross-functionally to lead process development, scale-up and tech transfers of new integrated products to ensure efficient and effective transitions from concept to commercial production. You will get an opportunity to identify solutions for co-encapsulated products that enable customers to utilize our sensor technology with approved medicinal products. You will also rely on your technical knowledge to innovate, design, and develop processes, procedures, and/or automation solutions to meet these goals. Additional facets of your role will include developing global contract manufacturing strategies and identifying key external organizations to build solid business relationships to ensure uninterrupted supply of digital medicines.

• Lead internal and external teams to build end-to-end manufacturing processes for digital drug products intended for clinical studies and commercial markets
• Manage deployment activities across multiple programs and provide resource allocation estimates required to meet corporate goals
• Lead scale-up and tech transfers to solid dose CMOs globally
• Identify and implement GMP compliant solutions for co-encapsulating sensors with medicinal products
• Partner with Digital Medicines Development at project kickoff phase to ensure product design for manufacturability
• Collaborate with internal/external teams in authoring CMC modules for IND and NDA filings
• Apply standard manufacturing analysis techniques such as flowcharting, Pareto analysis, cause & effect diagrams, root cause, and statistical process control to reduce variation and improve quality
• Additional Responsibilities:
• Oversee deployment team to insure adequate Person-In-Plant coverage at CMO sites
• Partner with Automation Engineering and external vendors to realize scale-up goals through new equipment and process introductions
• Author and review documentation in support of product design controls and overall Quality System
• Investigate and resolve manufacturing and supplier quality concerns (CAPA deviations)
  
• Act as liaison with CMO to confirm compliance to combination product regulations
• Oversee internal/external spending to adhere to approved budget

• Bachelors degree in Pharmaceutical/Engineering discipline with 15 years of solid experience; Advanced degree is a plus (Masters or PhD with solid relevant experience)
• Strong knowledge of cGMPs and other regulatory requirements governing pharmaceutical development, scale-up, and manufacturing
• Extensive knowledge of immediate release tablet formulations, analytical methodologies and understanding of GMP manufacturing to ensure rapid integration into production 
• Expertise with dry blending, wet granulation, tablet compression, film coating, and powder/bead encapsulation
• In depth understanding of pharmaceutical commercial manufacturing equipment for solid dosage forms
• Direct experience selecting and managing Contract Manufacturing Organizations (CMOs) 
• Experience with selecting and qualifying vendors for test services, raw materials, and primary/secondary packaging materials
• Strong background in solid oral dosage form manufacturing processes and guidance regulatory principles
• Strong strategic planning ability as well as detail-oriented thinking
• Proven experience mentoring, developing and effectively leading team members 
• Ability to plan and prioritize work for self and members of deployment team
• Structured problem solving skills
• Use of statistical techniques such as Statistical Process Control (SPC) and Design of Experiments (DOE) is a plus
• Knowledge of LEAN, Six Sigma, or other continuous improvement techniques is a plus
• Hands-on and capable of designing and implementing experiments

Reasoning Ability 

Ability to apply principles of logical thinking to a wide range of intellectual and practical problems.

Physical/Mental Demands 

The physical and mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit; use hands and/or fingers to handle or feel; reach with hands and arms; talk and hear. The employee is occasionally required to stand and walk. The employee may occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.

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.