The Bioprocessing Associate II for Manufacturing will be responsible for the manufacture of Master and Working Cell Banks, Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). The incumbent will be responsible for operating upstream and downstream equipment for adherent and suspension systems and performing production support activities while maintaining compliance to cGMP standards.
We are looking for individuals that are willing to work within a team, are hard-working, and highly motivated. This position requires multi-tasking and excellent peer-to-peer communication skills.
Responsibilities: • Understand concepts of aseptic technique. • Train, maintain and operate equipment. • Basic technical knowledge and background. • Participate/perform in tech transfer activities. • Assist with validation execution. • Received and organizes materials. • Identify/communicate discrepancies of material deliveries. • Use of support systems (SAP, Veeva, LIMs, etc). • Understands concepts of manufacturing process and methods. • Follows and understands GMPs. • Revises and authors SOPs. • Follows manufacturing batch records. • Participate in technical document authoring. • Use of basic Microsoft applications efficiently. • Suggests continuous improvements. • Some client interaction. • Work with a cross-functional team of process development, engineering, MSAT, F&E, and quality teams. • Cross trains in other areas and may be utilized to perform above job functions across the entire site. • Performs under direct supervision.
Requirements: • H.S/Assoc with 2+ years of experience, or B.S (science preferred) with 0-2 years of experience. • General knowledge of cGMP regulations. • Experience working in a Biological Safety Cabinet (BSC). • General knowledge of cell expansion vessels and purification equipment. • Ability to work well independently and as part of a team. • Exhibits attention to detail, accuracy in work, and integrity of character. • Self-starter who shows willingness to learn and problem-solve. • Willingness to learn and operate production equipment. • Able to adhere to all safety and company regulations. • Able to accommodate a flexible work schedule to support business demands. • Ability to carry up to 55 pounds. • Ability to stand for long periods of time while wearing PPE daily.