Associate Director - Injectable Drug Product Transfer & Validation

Alexion Pharma Spain S.L.; New Haven (CT); On-site; USD 150,000 - 190,000; Full time

Job summary

Alexion Pharma Spain S.L. is seeking an Associate Director for Injectable Drug Product Technology Transfer in New Haven, CT.

The role leads cross-functional teams to design, execute, and oversee technology transfers to GMP manufacturing sites, spanning biologics and complex modalities. The candidate will develop robust transfer and validation strategies, oversee unit operations (filtration, filling, lyophilization), and author pivotal regulatory documents, ensuring compliant IND/IMPD/BLAs.

Qualifications

• Ph.D. or advanced degree with extensive biopharmaceutical drug product development experience.
• Experience leading injectable drug product technology transfers and GMP manufacturing support.
• Strong knowledge of sterile manufacturing processes and regulatory submissions.

Responsibilities

• Lead cross-functional teams in design, execution, and oversight of injectable drug product technology transfers to GMP sites.
• Develop phase-appropriate technology transfer and process validation strategies, including risk assessments and control strategies.
• Oversee unit operations like sterile filtration, aseptic filling, lyophilization, stoppering, sealing, and visual inspection.
• Serve as technical SME during campaigns, providing on-site support, troubleshooting, and decision-making.

Skills

Leadership

Cross-functional leadership

GMP knowledge

Process development

Technology transfer

Regulatory submissions

Troubleshooting

CAPA

Data analysis

TrackWise

Education

Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or Engineering

M.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or Engineering

B.S. in Chemistry, Biochemistry, Pharmaceutical Sciences, or Engineering

Tools

TrackWise

Job description

Alexion Pharma Spain S.L. is seeking an Associate Director for Injectable Drug Product Technology Transfer in New Haven, CT.

The role leads cross-functional teams to design, execute, and oversee technology transfers to GMP manufacturing sites, spanning biologics and complex modalities. The candidate will develop robust transfer and validation strategies, oversee unit operations (filtration, filling, lyophilization), and author pivotal regulatory documents, ensuring compliant IND/IMPD/BLAs.