Rick Hellstrom Email & Phone Number

Thousand Oaks, Ca, Us

Head of Amgen’s New Autoinjector Platforms - responsible for design, development, coordinated filing activities and commercialization in a global manufacturing network across multiple products. Responsible for design transfer from an elite supplier base through global commercial production to ensure supply to every patient every time.

Thousand Oaks, Ca, Us

• Site Head / Program Technical Lead for a first in class pre-filled, pre-loaded wearable on-body device. • Led a team of over 45 professionals including Engineers, Risk, Regulatory, Quality, Supply Chain specialists, Finance and Global Sourcing. Provided technical leadership and contributions on global cross functional teams for devices through development, product filing and commercialization.• Provided project and engineering leadership in the feasibility, development, verification/validation and launch phases of device development. Key deliverables include user needs, component/assembly and manufacturing specifications, risk assessments, prototyping, test development, design verification and validation testing, device assembly and testing equipment development oversight and Design Transfer.• Extensive collaboration with internal and external partners.• Accountable for a $15M yearly budget, including RFP generation, contract awards, CDAs, Capital and Expense spending.• Broad experience including, Human factors testing, outsourced medical device development, manufacturing technologies and process development. • Developed, in collaboration with internal engineering teams, an effective scalable consistent process across multiple departments to support the creation, control and maintainability of all drawings and specification relevant to the design, manufacturing, testing and release of combination products.

Thousand Oaks, Ca, Us

Led and collaborated with varied stakeholders to develop yearly project requirements and budgets in support of Clinical Operations and GMP capital projects. Efficiently lead $10M+ project portfolios with over a dozen simultaneously active capital projects. • Worked cross-functionally within 5 separate buildings and organizations. Collaborated with clients (Automation, Quality, Engineering, IS, Sourcing, Controls, Safety and users) along with engineering vendors to establish system design requirements along with hardware and software specifications.• Managed CM/GC firms for demo, construction, equipment installation, IQ/OQ/PQ, training and client turnover.

Thousand Oaks, Ca, Us

Responsible for Commercial and Clinical Distribution groups along with warehouse/cold chain projects that included new building roles, budgeting, compliance, safety, process improvement, flexibility and capacity to ensure an uninterrupted Supply Chain. Responsible for global projects that impacted GMP warehousing, distribution, dispensing and controlled temperature environments.• Responsible for 3 teams (18 staff -2 Engineers, 2 Supervisors, 14 support staff) – Commercial Distribution, Clinical Distribution and Building Engineering. Directly responsible for Staff hiring, training, development and reviews.• Led global procedure updates/improvements including temperature monitoring, cell bank storage, warehouse capacity planning and cycle counting.

Founded an engineering design firm that provided technical documentation support, mechanical design, prototyping, device fabrication, testing, quality assurance, and technical transfer of equipment and processes to clients such as the U.S. Navy, U.S Air Force, Amgen and Yamaha.Responsibilities included project management, business development, strategic planning, design engineering, marketing, job proposals, contract negotiation, customer service and collaborating with outside vendors.

Master Of Business Administration (Mba)

Bachelors, Physics & Business Economics

Masters Certification, Project Management