SUMMARY 

Under supervision, the Manufacturing Associate, Upstream, will perform routine manufacturing activities in GMP manufacturing areas including fermentation and/or cell culture, and the associated sub-processes/preparation. Operations will be performed according to Standard Operating Procedures (SOPs) and batch records. Perform manufacturing steps, execute routine batch records, and revise documents such as batch records and SOPs as needed. Flexible shift schedule and overtime may be required.

JOB RESPONSIBILITIES

• Perform GMP manufacturing activities in assigned areas.
• Follow Standard Operating Procedures (SOPs), cGMPs, plant safety guidelines and other established procedures during the manufacturing process to produce quality products.
• Document Quality Events – IRs, DEVs, and OOTs.
• Initiate Change Controls and MasterControl DCCs.
• Set-up, operate, maintain and clean upstream bioprocessing equipment.
• Demonstrate good aseptic technique.
•  Basic troubleshooting of bioprocess equipment.
• Perform manual cleaning and sterilization of parts and components.
•  Accurately complete and maintain detail oriented process-related documentation of equipment logs and batch records following the good manufacturing documentation practices.
•  Draft and revise SOPs and batch records.
• Update manufacturing SOP binders.
•  Address production issues and report any compliance related concerns to supervisor.

JOB REQUIREMENTS

Education and Experience

•  Bachelor's or advanced degree in life sciences or related discipline, or equivalent education and experience. 
•  Bachelor's degree with 0-3 years of experience in the pharmaceutical or biotech industry, or equivalent education and experience.
• Knowledge, Skills and Abilities:
• cGMP manufacturing for biological product preferred..
• Upstream experience in cell passaging, aseptic technique, working with bioreactors, fermentors, and harvest filtration systems.
•  Fundamental knowledge of current biologics regulations and cGMP for drug substance operation.
•  Proficient with Microsoft Word and Excel. 
• Able to work with pressurized systems, steam, and corrosive chemicals with necessary safety precautions.
•  Demonstrated ability to follow and document activities in written procedures and/or logbooks.
• Detail oriented, strong team player. 
•  Effective collaboration skills and the ability to work cross functionally across categories and internal stakeholders.