Senior Biologics Drug Substance Tech Transfer Lead

AstraZeneca GmbH; Gaithersburg (MD); On-site; USD 138,000 - 208,000; Full time

Job summary

AstraZeneca seeks a Drug Substance Tech Transfer Lead to drive post-approval drug substance transfers across biologics portfolios, partnering with Global CMC and external sites to ensure scalable, reliable manufacturing.

You will lead technology transfer activities, assess site readiness, oversee transfer strategies, and work with cross-functional teams to deliver transfer readiness and lifecycle management across ADCs and other modalities.

Qualifications

• Bachelor's, Master's or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences or related.
• 8+ years of relevant experience in CMC matrix leadership, drug substance manufacturing, technology transfer, biologics process development, MS&T or related pharmaceutical/biologics operations.

Responsibilities

• Lead post-approval drug substance technology transfers across internal and external manufacturing sites, ensuring strong planning, execution, risk management and handover to commercial operations.
• Deliver against Global CMC requirements and represent Operations needs in transfer strategies, technical discussions and execution plans.
• Support NPI technology transfers, helping ensure processes are scalable, transferable and suitable for reliable commercial manufacturing.
• Apply working knowledge of upstream, downstream and conjugation operations to transfer strategy, technical assessments, issue resolution and implementation across diverse biologic modalities.
• Assess site capabilities for process transfer, scale-up and lifecycle changes, considering technical fit, equipment capability, facility readiness, capacity and compliance requirements.
• Partner with Manufacturing, MS&T, Quality, Regulatory, Supply Chain, Engineering and external partners to deliver plans aligned with business and supply priorities.
• Embed GMP, quality, inspection-readiness and technical-documentation expectations throughout transfer activities.
• Lead the identification, mitigation and resolution of process, equipment, site, compliance and supply risks.
• Drive standardisation, simplification and continuous improvement across the technology transfer network.
• Help reimagine ways of working through digital technology transfer tools that improve visibility, knowledge transfer, data quality, governance and execution efficiency.
• Influence decisions and build alignment across a complex matrix, including teams and stakeholders outside your direct reporting line.

Skills

CMC knowledge

Biologics transfer leadership

Transfer execution

Leadership & matrix collaboration

Quality systems & GMP

Regulatory awareness

Education

Bachelor's/Master's/PhD in Biochemical/ Chemical Engineering or related

Job description

AstraZeneca seeks a Drug Substance Tech Transfer Lead to drive post-approval drug substance transfers across biologics portfolios, partnering with Global CMC and external sites to ensure scalable, reliable manufacturing.

You will lead technology transfer activities, assess site readiness, oversee transfer strategies, and work with cross-functional teams to deliver transfer readiness and lifecycle management across ADCs and other modalities.