Materials Specialist, Cell and Individualized Therapies (ASPIRE)

Company: Disability Solutions
Location: Hillsboro
Posted on: March 13, 2023

Job Description:

The PositionAt Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients' lives. We are courageous in both decision and action, we believe that good business means a better world.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.Job Summary: 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. 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 nonGMP 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 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 ---Please note this position is eligible for relocation benefits#LI-AD1#ptcareers#cellandgenetherapycareers#Who we areA member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company's health and safety obligations and/or applicable law or guidelines.Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We're focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work.Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage.

Keywords: Disability Solutions, Hillsboro , Materials Specialist, Cell and Individualized Therapies (ASPIRE), Healthcare , Hillsboro, Oregon