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Rick Hellstrom is a Director - Autoinjector Platform Lead at Amgen at Amgen. He possess expertise in gmp, change control, biotechnology, quality assurance, biopharmaceuticals and 22 more skills.
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Director - Autoinjector Platform LeadAmgen Jun 2019 - PresentThousand Oaks, Ca, UsHead 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. -
Senior Manager Device Engineering – Drug DeliveryAmgen Jul 2013 - Jun 2019Thousand 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.
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Senior Capital Project ManagerAmgen Apr 2006 - Jul 2013Thousand Oaks, Ca, UsLed 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.
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Manager Distribution Center, Global Supply ChainAmgen Feb 2003 - Apr 2006Thousand Oaks, Ca, UsResponsible 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.
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PrincipleRicarl Design Jan 1996 - Feb 2003Founded 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.
Rick Hellstrom Skills
Rick Hellstrom Education Details
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California Lutheran UniversityMaster Of Business Administration (Mba) -
Uc Santa BarbaraPhysics & Business Economics
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Villanova UniversityProject Management
Frequently Asked Questions about Rick Hellstrom
What company does Rick Hellstrom work for?
Rick Hellstrom works for Amgen
What is Rick Hellstrom's role at the current company?
Rick Hellstrom's current role is Director - Autoinjector Platform Lead at Amgen.
What is Rick Hellstrom's email address?
Rick Hellstrom's email address is ri****@****arl.com
What is Rick Hellstrom's direct phone number?
Rick Hellstrom's direct phone number is +180538*****
What schools did Rick Hellstrom attend?
Rick Hellstrom attended California Lutheran University, Uc Santa Barbara, Villanova University.
What skills is Rick Hellstrom known for?
Rick Hellstrom has skills like Gmp, Change Control, Biotechnology, Quality Assurance, Biopharmaceuticals, Cross Functional Team Leadership, Fda, Validation, Process Improvement, Technology Transfer, Quality System, Project Management.
Who are Rick Hellstrom's colleagues?
Rick Hellstrom's colleagues are Jodie Custard, Solomon Nigusie, Emilio Frangella, Jibin Jeon, Wibo Run Van, Ana Paula Puca Ribeiro, Stephanie Bender.
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