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.
- 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