Manufacturing Associate II

Contract Other Production Occupations

Job Description

Job Description The Manufacturing Associate II is responsible for supporting the overall GMP upstream or downstream manufacturing process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II & commercial GMP manufacturing.• Lifting to 40 lbs., unassisted may be required at times.

• Frequent standing and walking is required, as this role requires presence on the manufacturing floor.

• Shift work and weekend work is required. KEY RESPONSIBILITIES:

• Completes Batch Production Records under cGMP, and documents in detail through the use of SOPs and BPRs for the processes and manufacturing steps

• Generates operational protocol(s), internal or external documents including SOPs, BPRs, deviations and summary reports

• May work with Process Development team...