Associate Director, Injectable Drug Product Tech Transfer

AstraZeneca plc; New Haven (CT); On-site; USD 150,000 - 210,000; Full time

Job summary

AstraZeneca plc in New Haven, CT seeks an Associate Director to lead development, transfer, and validation of sterile injectable drug products across biologics, peptides, nucleic acids and synthetic molecules. You will supervise technology transfer, process validation, and regulatory submissions, guiding cross‑functional teams and mentoring staff to ensure GMP compliance and on‑time delivery.

The role requires deep hands‑on experience with sterile manufacturing, risk assessments, and CDMO

Qualifications

• Ph.D. in Chemistry, Biochemistry, Pharmaceutical Sciences, or Engineering with 8+ years in biopharmaceutical drug product development and manufacturing.
• MS with 12+ years or BS with 15+ years in biopharmaceutical drug product development and manufacturing.
• Proven leadership in injectable drug product development and technology transfer, including experience with biologics and complex modalities.
• Deep technical knowledge of sterile manufacturing processes and equipment, including single-use systems.
• Strong understanding of GMP regulations, process validation, and regulatory submission requirements and supporting regulatory inspections as a technical SME.
• Experience managing or mentoring technical staff and leading cross-functional project teams in late-phase development and commercial product launches.
• Proficiency with electronic quality systems (e.g., TrackWise) and data analysis tools.
• Excellent communication, collaboration, and problem‑solving skills.

Responsibilities

• Lead cross-functional teams in the design, execution, and oversight of injectable drug product technology transfers to internal and external GMP manufacturing sites.
• Develop and implement robust, phase-appropriate technology transfer and process validation strategies, including risk assessments, FMEAs, and control strategies.
• Oversee development and optimization of drug product unit operations such as freeze/thaw, mixing, sterile filtration, aseptic filling, lyophilization, stoppering, sealing, and visual inspection.
• Serve as the technical lead during manufacturing campaigns, providing on‑site support, troubleshooting, and decision‑making in collaboration with Process Development, QA, and Operations.
• Author and review technical documentation including batch records, validation protocols, change controls, deviations, and regulatory filings (IND, IMPD, BLA, MAA).
• Monitor and trend process performance data; lead investigations and implement CAPAs as needed.
• Collaborate with internal and external stakeholders to ensure alignment on timelines, deliverables, and technical strategy.
• Lead or contribute to continuous improvement initiatives to enhance the efficiency and effectiveness of technology transfer and manufacturing support processes.
• Stay current with industry trends, regulatory expectations, and emerging technologies in injectable drug product development.
• Mentor junior staff and contribute to resource planning, budgeting, and departmental strategy.
• Travel domestically and internationally (~25%) to support manufacturing site activities.

Skills

Leadership

Cross‑functional leadership

Technology transfer

Process development

Regulatory submissions

Sterile manufacturing

Quality systems

Data analysis

Education

Ph.D. in Chemistry/Biochemistry/Pharmaceutical Sciences/Engineering

M.S. in relevant field

B.S. with 15+ years experience

Tools

TrackWise

Job description

AstraZeneca plc in New Haven, CT seeks an Associate Director to lead development, transfer, and validation of sterile injectable drug products across biologics, peptides, nucleic acids and synthetic molecules. You will supervise technology transfer, process validation, and regulatory submissions, guiding cross‑functional teams and mentoring staff to ensure GMP compliance and on‑time delivery.

The role requires deep hands‑on experience with sterile manufacturing, risk assessments, and CDMO