Manufacturing Associate III
Biogen
3 months ago
On-site
Triangle, NC
Operations
Shift / Role Details:
- 2-2-3 calendar rotation on Days (5:45 AM–6 PM ET)
- Manufacturing Associates perform processing steps and manufacturing support in the Drug Substance facility (Research Triangle Park, RTP) in a clean environment governed by cGMP.
Responsibilities:
- Execute daily manufacturing activities by operating production equipment, performing process steps, and completing validation/qualification protocols per cGMP and SOPs.
- Document all work accurately (cGMP data, deviations, equipment usage, processing details); create/revise/maintain batch records, SLRs, equipment logbooks, and key documentation.
- Support in-process sampling and analysis (e.g., pH, conductivity, protein concentration, osmolality, cell counts).
- Maintain a clean, safe, audit-ready workspace (safety, housekeeping, and compliance).
- Collaborate with the team; participate in training and development.
Upstream/Cell Culture (examples):
- Mammalian cell culture & harvest using shake flasks, WAVE bags, centrifuges, and stainless steel bioreactors up to 15,000L.
- Perform thaws and splits using aseptic technique.
Required Skills:
- Bachelor’s + 6 months direct experience, or BioWorks Certificate/associate’s + 1 year, or HS diploma/equivalent + 1.5 years (direct experience).
- Experience in cGMP manufacturing/biotech/pharma operations.
- Follow detailed procedures; uphold safety/compliance.
- Familiar with production equipment and manufacturing documentation.
Preferred Skills:
- STEM bachelor’s degree.
- Strong communication skills; team-oriented mindset.
Benefits (highlights):
- Medical, dental, vision, life; fitness/wellness reimbursement; short/long-term disability.
- 15+ days paid vacation; end-of-year shutdown (Dec 26–Dec 31).
- Holidays, sick time, paid maternity/parental leave, 401(k) match, tuition reimbursement (up to $10,000/yr).
- 2-2-3 calendar rotation on Days (5:45 AM–6 PM ET)
- Manufacturing Associates perform processing steps and manufacturing support in the Drug Substance facility (Research Triangle Park, RTP) in a clean environment governed by cGMP.
Responsibilities:
- Execute daily manufacturing activities by operating production equipment, performing process steps, and completing validation/qualification protocols per cGMP and SOPs.
- Document all work accurately (cGMP data, deviations, equipment usage, processing details); create/revise/maintain batch records, SLRs, equipment logbooks, and key documentation.
- Support in-process sampling and analysis (e.g., pH, conductivity, protein concentration, osmolality, cell counts).
- Maintain a clean, safe, audit-ready workspace (safety, housekeeping, and compliance).
- Collaborate with the team; participate in training and development.
Upstream/Cell Culture (examples):
- Mammalian cell culture & harvest using shake flasks, WAVE bags, centrifuges, and stainless steel bioreactors up to 15,000L.
- Perform thaws and splits using aseptic technique.
Required Skills:
- Bachelor’s + 6 months direct experience, or BioWorks Certificate/associate’s + 1 year, or HS diploma/equivalent + 1.5 years (direct experience).
- Experience in cGMP manufacturing/biotech/pharma operations.
- Follow detailed procedures; uphold safety/compliance.
- Familiar with production equipment and manufacturing documentation.
Preferred Skills:
- STEM bachelor’s degree.
- Strong communication skills; team-oriented mindset.
Benefits (highlights):
- Medical, dental, vision, life; fitness/wellness reimbursement; short/long-term disability.
- 15+ days paid vacation; end-of-year shutdown (Dec 26–Dec 31).
- Holidays, sick time, paid maternity/parental leave, 401(k) match, tuition reimbursement (up to $10,000/yr).