Senior Associate Director: Injectable Drug Product Tech Transfer

Alexion Pharmaceuticals, Inc.; New Haven (CT); On-site; USD 180,000 - 260,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. is seeking an Associate Director of Sterile Drug Product Development to lead end-to-end technology transfer, process development, scale-up and regulatory readiness across biologics, peptides and small molecules.

The role covers liquid and lyophilized formulations in vials, prefilled syringes, and cartridges. You will oversee tech transfer from design to validation, supervise manufacturing campaigns, and mentor junior staff while collaborating with QA, Process

Qualifications

• PhD/MS/BS with years of drug product development and manufacturing experience.
• Proven leadership in injectable drug product development and tech transfer.
• Strong GMP knowledge and regulatory submission experience.
• Experience with biologics and complex modalities.

Responsibilities

• Lead cross-functional teams in tech transfers to GMP sites.
• Develop phase-appropriate tech transfer and validation strategies.
• Oversee unit operations: sterile filling, lyophilization, inspection.
• Serve as technical SME during campaigns, on-site support and decisions.
• Author/review batch records, validation protocols, deviations, regulatory filings.
• Monitor process data, lead CAPA investigations, implement improvements.
• Collaborate with stakeholders to align timelines and strategy.
• Mentor staff and contribute to budgeting and planning.
• Travel domestically and internationally ~25% for site activities.

Skills

Leadership

Cross-functional collaboration

Problem solving

Communication

Education

PhD in Chemistry

PhD in Biochemistry

PhD in Pharmaceutical Sciences

PhD in Engineering

MS with 12+ years

BS with 15+ years

Tools

TrackWise

Data analysis tools

Job description

Alexion Pharmaceuticals, Inc. is seeking an Associate Director of Sterile Drug Product Development to lead end-to-end technology transfer, process development, scale-up and regulatory readiness across biologics, peptides and small molecules.

The role covers liquid and lyophilized formulations in vials, prefilled syringes, and cartridges. You will oversee tech transfer from design to validation, supervise manufacturing campaigns, and mentor junior staff while collaborating with QA, Process