Just-Evotec Biologics is seeking a highly motivated Materials Specialist that desires a significant opportunity to improve worldwide access to biotherapeutics. Materials Specialists 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 for Just-Evotec Biologics state of the art J.POD™ Facility, located in Redmond WA. The Primary Job Responsibilities include:
Qualifications / Requirements
- Perform all work activities in a safe and compliant manner according to all Just. Biotherapeutics policies, procedures, and trainings.
- Using manual labor, pallet jacks, and forklifts, receive, identify, quarantine, store, handle, dispense, release, and issue raw materials, starting materials, intermediates, reagents, labels, GMP supplies and packaging materials to and from storage locations
- Maintain general supplies, orders, and re-stock GMP areas as required.
- Weigh and dispense powder and liquid chemicals to support buffer and media prep
- Assist with maintaining an accurate inventory (paper and electronic), expiration, and retest records for all GMP materials.
- 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)
- Coordinate disposition of all expired materials and maintain applicable documentation.
- Participate in internal GMP inspections when needed
- Interface with a variety of departments when coordinating shipping and receiving.
- 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
- 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
- Assorted additional duties as assigned.
About Just - Evotec Biologics
- BA or BS degree in Business Administration or related fields is preferred
- APICS certification a plus
- 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
Just - Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at