MANUFACTURING ASSOCIATE I/II, DOWNSTREAM

Manufacturing Pleasanton, CA


Description

The Manufacturing Associate will execute activities associated with purification manufacturing in a clean room environment. This role will also need to assist with cell culture, aseptic fill, and buffer prep processes as well as maintain material inventory in labs. 

Summary of essential job functions

  • Possess experience in cGMP manufacturing environment.
  • Possess experience in purification activities including but not limited to tangential flow filtration, anion exchange chromatography, and diafiltration.
  • Possess experience with aseptic filling and inspection.
  • Responsible for day to day manufacturing activities including stocking of materials, preparation of documentation, cleaning and sanitization of rooms and equipment, operation of process equipment.
  • Stocking production area with supplies
  • 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.
  • Executing process steps according to defined SOPs and batch records
  • Documenting activities in accordance with cGMPs
  • Following accurate verbal and written procedures in operating production equipment and performing processing steps; accurately completes appropriate production documentation
  • Maintaining cleanliness and orderliness of operational area
  • Actively contribute to successful development, qualification and execution of robust manufacturing processes in support of company pipeline projects
  • Identifying process and quality problems and following corrective actions
  • Demonstrating knowledge and understanding of GMPs and how they apply to specific responsibilities 
  • Maintaining a safe working environment
  • Following company policies and procedures
  • Work schedule dependent on company needs
Minimum Education/Experience

The ideal candidate for this position will have demonstrated in-depth experience with GMP production.

  • BS in Biological Sciences or related scientific discipline
  • 0 - 2 years or more in a cGMP manufacturing environment
  • Knowledge of GMP and regulatory requirements preferred
Other Qualifications
  • Ability to lift up to 50 lbs
  • Manual dexterity
  • Strong organizational skills and attention to detail
  • Able to work effectively in a fast-paced, small start-up company environment.
  • Self-motivated, self-disciplined and able to function independently as well as part of a team.
  • Strong critical and logical thinking with ability to analyze problems
  • Strong ability to prioritize, multi-task, and work in an evolving environment
  • Excellent presentation and written/verbal communication skills.
  • Excellent computer proficiency (MS Word, Excel, PowerPoint)