Cell Therapy Mfg. Associate - ACP

We have a fantastic new job opportunity for a Cell Therapy MFG Associate I to join our Cell Therapy programs here  incumbent should function as a member of the Bloodworks Bio Advanced Therapies department, performing the technical aspects of receiving, labeling, processing, testing, storing, and distributing products and samples handled by the Advanced Therapies Laboratory. Additionally, performs activities related to the nonconformance process, data entry and review, and validation protocols.

• Consistently model values of Bloodworks and coach for the same expectation; contribute and build upon current practices and procedures in support of values, mission, and goals.
• Always follow Good Documentation Practices (GDP).
• Prepare laboratory supplies and reagents.
• Ensure an adequate supply of the equipment and supplies required for processing and testing.
• Operate and maintain laboratory equipment and instruments.
• Receive and evaluate the acceptability of products and samples.
• Send samples for testing and receive test results.
• Complete training and competency documentation for special equipment and pertinent regulations controlling these products.
• Initiate departmental nonconformances.
• Label, process, test, cryopreserve, and/or store products and samples, including:
  • Fractionation, cryopreservation, and aliquoting
  • Flow assays, manual cell count and viability, and CBCs.
• Support manufacturing and maintenance activities in classified ISO-5,
  -7, and
  -8 cleanroom areas.
• Assist with executing validations.
• Create, modify, maintain, and transmit electronic records in a controlled and approved manner in conformance with FDA requirements.
• Fully participate as a member of the Advanced Therapies and Bloodworks teams by ensuring interactions with colleagues promote collaboration and effective communication.
• Perform most work under direct supervision.
• Work one weekend day as part of the regular schedule.

• Consistently model Bloodworks' values; contribute and build upon current practices and procedures in support of values, mission, and goals.
• Maintain confidentiality of donor and patient medical, financial, and personal information in accordance with HIPAA and other applicable standards/guidelines.
• Function effectively within the team; participate and contribute constructively to produce results collaboratively; exhibit respect for others as well as willingness to help others.
• Positively challenge and support peers to ensure all contribute to the organization's success.
• Provide timely, honest feedback to team members to improve team performance.
• Communicate with leadership about any obstacles to personal growth or team success.
• Comply with all applicable Standard Operating Procedures (SOP) as written.
• Recognize potentially hazardous materials, equipment, and situations and follow safety procedures to minimize risk to self and nearby individuals.
• Proactively recommend systems, resources, and procedures to achieve the department's success.
• Responsibly support the department budget by avoiding late lunches and unnecessary overtime, minimizing reagent/material waste, and promptly communicating low supply levels.
• Establish and maintain collaborative relationships with internal and external customers to contribute to the success of the department and the organization.
• Ensure the department's actions comply with laws, regulations, and organizational policies and practices.
• Participate in Bloodworks-mandated emergency drills.
• Perform other duties as assigned.

• Must qualify as Testing Personnel, Moderate Complexity Testing, under CLIA personnel requirements found in Subpart M of the Code of Federal Regulations.
• Bachelor of Science in medical technology, laboratory science, chemical, physical, or biological science (or equivalent combination of education and experience).
• Experience with flow cytometric analysis is desirable.
• Experience with ISO-certified clean rooms is desirable.
• Experience with operating biological safety cabinets (BSCs) is desirable.

• Maintain competency and proficiency in departmental Core Policies, Processes, and Procedures beyond the initial 6 months of hire to the current position.
• Functional proficiency with MS Office applications (Word, Excel, PowerPoint, Outlook, Access).
• Knowledgeable about the safe handling of any potentially infectious material, such as blood or…