This position is part of Genentech’s Hillsboro Individualized Therapies plant. Hillsboro Individualized Therapies is a new manufacturing facility for novel cellular and individualized therapies. The plant is located on the Genentech Hillsboro Campus in Hillsboro, Oregon.
This position is part of Genentech’s exciting Individualized and Cell Therapies program based in Hillsboro, Oregon. 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.
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 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 nonGMP supplies to and from storage locations and delivery trucks
Assorted additional duties as assigned.
BA or BS degree in Business Administration or related fields is preferred
Materials Specialist = 4-5 years, Senior Materials Specialist = 5-6 years, Master Materials 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
To apply for this job please visit careers.gene.com.