Associate Director, External Drug Product Manufacturing

Scorpion Therapeutics; Hampton (NJ); On-site; USD 140,000 - 200,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director to oversee aseptic drug product manufacturing at CMOs, supporting both clinical and commercial production demands. You will provide on-site oversight, manage forecasting, onboard new CMOs, review master and batch records, investigate deviations, and liaise with clinical and commercial teams for product planning and invoicing.

The role requires a Bachelor’s or Master’s in Engineering or Biological Sciences and 5–8 years in aseptic fill operations

Qualifications

• 5-8 years managing aseptic fill operations at CMOs or in-house
• Experience coordinating with internal and external resources
• Knowledge of secondary packaging, batch record writing, and regulatory compliance in cGMP environments

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

Skills

Aseptic fill operations

CMO management

Regulatory compliance (cGMP)

Batch record writing

Process validation

Education

Bachelor’s or Master’s in Engineering or Biological Sciences

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