Master Materials Specialist, iNeST

United States of America, Oregon, Hillsboro

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Please note there are multiple positions available. We are hiring at multiple levels: Materials Specialist, Senior Materials Specialist, and Master Materials Specialist.

Main Purpose of the Position:

This position is part of Genentech’s’ Pharma Technical - individualized NeoAntigen Specific Therapy (iNeST) team based in Hillsboro, Oregon.  iNeST is a next generation immunotherapy for the treatment of patients with cancer on a per patient basis. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of manufacturing equipment, processes, and the quality approach for this exciting and novel technology.

Materials Specialist / Technician III / Technician II are responsible for the execution of product logistics in a cGMP environment.  This includes the receipt and inspection, storage, wipe down and issuance of kitted and non-kitted GMP materials used in production and final product shipping/distribution to our customers.  Other responsibilities included performing data entry into various business systems and databases ensuring department compliance with policies and procedures.
 

Responsibilities:

  • Perform all work activities in a safe and compliant manner according to all Genentech policies, procedures and trainings
  • Receive, identify, quarantine, store, handle, dispense, release, and issue raw materials, starting materials, intermediates, reagents, labels, GMP supplies and packaging materials.
  • Assist with maintaining an accurate inventory (paper and electronic), expiration, and retest records for all GMP materials.
  • Coordinate disposition of all expired materials and maintain applicable documentation.
  • Participate in internal GMP inspections when needed
  • Proficient in both DOT & IATA shipments, including applicable certifications.
  • Interface with a variety of departments when coordinating shipping and receiving.
  • Maintain appropriate training for import/export shipping and receiving. Proficient in associated documentation for all import/export activities.
  • Maintain general supplies, orders and re-stock GMP areas as required.
  • Preform and assist with deviations, change control, and corrective / preventive actions within the established Quality management system
  • Ability to create and revise standard operating (SOP) reverent to department processes
  • Access various business systems and input data with a high level of accuracy (i.e. decommissioning of materials, material destruction, plant to plant movements, and other non-routine ERP transactions)
  • Record creation, collection and storage per corporate retention schedules
  • Perform department related project activity that may include investigating, analyzing, formulating possible solutions, documenting processes, and communicating results
  • Schedules transportation for outgoing shipments for inbound and outbound operations
  • Using manual labor, pallet jacks, and forklifts, move product and both GMP and non-GMP supplies to and from storage locations and delivery trucks
  • Assorted additional duties as assigned.

Qualifications / Requirements:

  • BA or BS degree in Business Administration or related fields is preferred
  • Materials Technician II = 4-5 years, III = 5-6 years, Specialist = 7+ years of experience.
  • Ability to follow detailed verbal and written instruction
  • Good basic mathematical skills
  • Ability to repeatedly lift 50 lbs
  • Proficiency with PC desktop applications and business operations software system
  • Ability to lead, coach, and influence in a highly cooperative and dynamic environment
  • Flexibility in assignments and able to work over-time, holidays, weekends and different shifts as required to meet business and customer needs
  • Strong organizational, communication and interpersonal skills
  • Valid driver’s license with acceptable driving record (if applicable)
  • Experience and proven abilities to analytically investigate and troubleshoot system issues and drive the implementation of solutions.
  • Demonstrated ability to plan, prioritize, and execute work appropriately with minimal supervision
  • Experience in Quality management systems working on deviations, change control, and corrective / preventive actions
  • Experience in Lean methodologies
  • Experience with cell therapy manufacturing is preferred
  • Experience in personalized health care environment preferred