Manufacturing Associate - Cell Culture / Inoculum in Fremont, CA at Apex Life Sciences

Date Posted: 4/5/2018

Job Snapshot

Job Description


Duties:

  • Executes routine unit operations in Cell Culture, Cell Inoculum as assigned related to the manufacturing of bulk drug substance in a multi-product facility. This may include cell inoculation and transfer in shake flasks and wave bioreactors. Performs duties under limited supervision and according to standard operating and manufacturing procedures.
  • Executes routine unit operations in Cell Culture such as Thaw, cell inoculation, cell separation and media batching.
  • Practices ergonomic safety and use appropriate personal protective equipment (PPE) in all operations.
  • Performs in-process analytical instrument measurements of e.g. pH, cell viability and viable cell density, osmolality, gas content, metabolites, spectrophotometry, or conductivity.
  • Documents execution of operations through the Bio Manufacturing Execution System (BioMES), batch record and equipment use logbook using Good Documentation Practices (GDP).
  • Performs internal support duties including stocking consumables/materials, updating controlled SOP binders, appropriately discarding expired reagents, recognizing and reporting process and equipment anomalies.
  • Reports any issues related to manufacturing performance, process and safety to the team lead or Manager in order to ensure safety and compliance with regulations and cGMPs and to facilitate continuous process improvement.
  • Participates in training and development opportunities in order to gain an understanding of SOPs, GMPs, regulatory compliance requirements and departmental policies.
  • Performs routine housekeeping of the manufacturing plant using the 5S organization methodology by using appropriate equipment safety signage, labeling of parts-in-process, sweeping water pools to the floor drain, and picking up parts from the floor.
  • Collaborates within team and department in order to follow best practices and meet department goals.

Skills:

  • Bachelors Degree with a focus in Biopharmaceuticals
  • Experience working with established GMP procedures and bulk manufacturing.
  • Technical knowledge of manufacturing systems, methods and procedures.
  • Understanding of cell culture processes.
  • Experience in Current Good Manufacturing Practices, Mammalian cell culture, Bio Manufacturing Execution System (BioMES), Process Control System DeltaV, Laboratory Management Information System (LIMS) preferred
  • Possess effective troubleshooting skills with equipment and/or process.
  • Demonstrated ability to be organized and work well in small work groups. 
  • Must be able to assist in trouble shooting activities and repairs to production equipment under the guidance of more experienced technicians. 
  • Demonstrated mathematical skills, including the ability to perform addition, subtraction, multiplication, division, and      conversions.
  • Detail oriented. Demonstrated ability to read, comprehend, and follow written instructions. 
  • Demonstrated written and verbal communication skills are required.
  • Must be able to work in a team environment. 
  • Experiences in related biotechnology/pharmaceutical industry strongly preferred
  • Must be able to learn and perform basic computer operations such as MS Office and Outlook and other computer based software