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:
- Has experience performing aseptic technique
- Can identify unacceptable practices of aseptic technique.
- Able to make on the spot corrections for aseptic technique.
- Understands basic operation/function of equipment.
- Perform basic troubleshooting for equipment.
- Industry technical knowledge and background.
- Basic/fundamental Engineering or mechanical knowledge.
- 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).
- Has performed and understands concepts of manufacturing process and methods.
- Identifies and understands acceptable and unacceptable practice of manufacturing process and methods.
- Follows and understands GMPs.
- Revises and authors SOPs.
- Revises and authors manufacturing batch records
- Train others on basic SOPs, equipment, and unit operations
- Provides information for technical document authoring.
- Use of basic Microsoft applications efficiently.
- Suggests and participates continuous improvements.
- Minimal 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 minimal supervision.
- Starts to work independently on basic tasks/process.
Requirements:
- H.S/Assoc with 3+ years of experience, or B.S (science preferred) with 1+ years of experience.
- Working knowledge of cGMP regulations.
- Experience working in a Biological Safety Cabinet (BSC).
- Effective written and verbal communication skills, with excellent teamwork aptitudes.
- Preferred experience includes working with incubators, pipettes, single-use bioreactors, aseptic operations, cell culture, seed scale-up, single-use chromatography and UF/DF systems, and ultracentrifuges.
- Working knowledge of cell expansion vessels such as T-flasks or shake flasks and viral vector purification methods for gene therapy products.
- Ability to work well independently, as part of a team, and establish working interdepartmental relationships.
- Exhibits attention to detail, accuracy in work, and integrity of character.
- Self-starter who shows ability to learn and problem-solve.
- Exhibits technical aptitude 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
Physical Requirements:
- Ability to carry up to 55 pounds.
- Ability to stand for long periods of time while wearing PPE daily
