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Job description
Role
Associate Director overseeing aseptic drug product manufacturing at CMOs, supporting both clinical and commercial production demands.
Responsibilities
provide on-site oversight (person-in-plant)
manage forecasting
request quotations
liaise with clinical and commercial teams for product planning
onboard new CMOs
review master and batch records
investigate deviations
review invoices
Qualifications
Bachelor’s or Master’s in Engineering or Biological Sciences
5-8 years managing aseptic fill operations at CMOs or in-house
experience with internal and external resources
knowledge of secondary packaging, batch record writing, and regulatory compliance in cGMP environments
High-Value
aseptic biopharmaceutical manufacturing (vials, pre-filled syringes)
quality standards
validation
project management
international travel (~10-20%)
cGMP
batch records
SOPs
WorkSetup
global travel required
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Worksite address
hampton, NJ, 08827, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.