MANUFACTURING ASSOCIATE II/III - DOWNSTREAM

Manufacturing Pleasanton, CA


Description

Position Summary

Gritstone bio is an immunotherapy company developing next-generation cancer and infectious disease therapeutics. Our approach focuses on generating a therapeutic immune response in these patients by unleashing the natural power of a patient’s immune system to recognize and destroy tumors or virally infected cells.


The Manufacturing Associate II/III will execute activities associated with downstream manufacturing in a clean room environment. Processes will be focused on purification of viral vector based cancer vaccine products. This role will also need to assist with cell culture processing, Virus production, aseptic filling, and buffer prep processes as well as maintain material inventory in labs.

Responsibilities
  • Must be able to work a 10-hour shift, 4 days per week including at least 1 weekend day each week (Sun-Thurs or Wed-Sat).
  • Possess experience in cGMP manufacturing environment.
  • Responsible for TFF, column chromatography, and other associated purification operations. Assist in planning monthly workload, preparation of documents, operation of process equipment, stocking of materials, and cleaning/sanitization of parts, rooms, and equipment.
  • Responsible for training new hires and maintaining up-to-date on-the-job training for current staff.
  • Proficient in revising and/or writing Standard Operating Procedures and Batch Production Records.
  • Demonstrate knowledge of mammalian cell culture process, vial thaw, cell culture passaging, cell count, reactor preparation, inoculation and transfection. Possess experience maintaining cell lines in small to medium scale bioreactors.
  • Assist with day to day upstream (mammalian cell culture) manufacturing activities.
  • Ability to document activities in accordance with cGMPs.
  • Follow accurate verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation.
  • Maintain cleanliness and orderliness of operational area.
  • Ability to identify process and quality problems and follow corrective actions.
  • Lead and/or participate in writing deviations and performing root cause investigations.
  • Demonstrate knowledge and understanding of GMPs and how they apply to specific responsibilities.
  • Maintain a safe working environment.
  • Follow company policies and procedures.
Minimum Education & Experience

  • The ideal candidate for this position will have demonstrated experience with cell culture in GMP manufacturing within a cleanroom environment.
  • BS in Biological Sciences or related scientific discipline
  • 3+ years in a cGMP manufacturing environment
  • Must be able to pass aseptic gowning and aseptic processing qualification and have ability to work in cleanroom for up to 8 hours a day.
  • Must be able to execute process steps according to defined SOPs and batch records.
  • Knowledge of GMP and regulatory requirements preferred
  • Experience in lean manufacturing, continuous improvement, Kaizen, 5S a plus.
  • Ability to lift items up to 50 lbs.
  • Ability to execute equipment validation and/or Process Development Protocols.
  • Excellent written and verbal communication skills.
  • Computer proficiency (MS Word, Excel, PowerPoint).