Duration
- 12 months
Description
- Must be open to all shifts. (This position will be mostly Day and swing shift primarily BUT will need to be flexible to support night shift as needed)
- Our client is looking for a Manufacturing Engineer consultant to come in and be able to work independently hitting the ground running. Flexibility to work nights weekends is required due to 24 hour manufacturing.
- This person will be assisting with defining the manufacturing campaign and what it looks like.
- SOPs of the manufacturing process will be owned by these consultants, upstream or downstream based on exp. Ownership of this manufacturing campaign and unit will be given to these individuals. Downstream exp is ideal to supplement the current team however candidates with both upstream and downstream or just upstream experience could be viable depending on background
- Average day will consist of revising / finding gaps in the SOPs (SOP’s are established), discussions based on ongoing operation to revise a few things gaps may need to open. Campaign phase routine manufacturing activities every day, this person will be on the floor executing with the rest of the team, once settled in position they will be responsible for revisions of documents, communications and interactions with cross functional teams and collaboration with those folks before the documents are completed and making sure all alignments are there between teams.
- This project will Start with solution preparation of campaign, then upstream phase support, execute those upstream manufacturing activities cell expansion, cell culture, purification, solution prep, chem wave.
- Could also be involved in transferring (tech transfer) of additional new products into facility so potential tech transfer activities of new products
- Would also be involved with the tech transfer
Must
- Upstream OR Downstream, Manufacturing for biotech (monoclonal antibody)
Bay Area, CA: Manufacturing Engineer (235119)
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