Shifts Available:
1st shift: 7AM - 7PM (2-2-3 ROTATION)
3rd shift: 7PM - 7AM (2-2-3 ROTATION)
Job Description:
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.
- Excellent documentation skills including comprehension, review & establishing Batch Production Records, SOP’s, deviation & summary reports
- Thorough knowledge of current Good Manufacturing Practices (cGMP’s), and all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
- Must be team-oriented (proactively builds healthy working relationships between peers, their department and other groups).
- Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
- Possesses a basic knowledge of non-manufacturing functions such as QC, Regulatory, QA, and/or Materials Management.
Qualification:
• HS or GED with 4-7 years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
OR
• Associate's degree in a Scientific, Engineering or Biotech field with 2-4 years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance
OR
• Bachelor's degree in a Scientific, Engineering or Biotech field with 1-3 years' experience with upstream (fermentation/bioreactor) or downstream (column chromatography, buffer/media skid) biologic production processes under GMP compliance