Job Description

• Provide cell culture, cell line development, cell harvesting and banking operations to upstream pharmaceutical manufacturing • Prepares manufacturing support materials such as buffers • Execute downstream and microbial purification processes in a cGMP environment • Provide expertise with working in bench scale to large scale fermentation by working with bioreactors • Participate in the editing and revision of Standard Operating Procedures (SOP's) • Actively support SIP (sterilization in place) and CIP (clean in place) to manufacturing equipment to ensure aseptic technique within the manufacturing processes • Responsible for ensuring proper documentation and execution of BPRs and activity records, according to cGMP regulations. • Develop, write, and review Standard Operating Procedures and Batch Production Records (BPRs). • Ensure documentation (batch records and SOPs) are accurate and updated as required. • Prepares manufacturing equipment such as packing of chromatography columns. • Cross-functional communication with tech transfer team, quality and engineering as necessary. • Cross-shift communication with first shift. Actively participates in shift exchange activities and communication channels. • Receive raw material/ production items as needed.