Drug Substance Tech Transfer Lead

AstraZeneca•Gaithersburg, MD

9d•Hybrid

About The Position

Help turn molecules into medicines by leading robust technology transfers across a diverse biologics portfolio. Make a positive impact, in a team where it means more. In Operations, we have a bold ambition: to deliver more medicines to patients, more quickly and affordably. Backed by investment, strong leadership and a clear plan, we combine personal dedication with fresh thinking to turn an increasingly complex pipeline from molecule to medicine. Join a global, inclusive team that is evolving how we work through Lean practices, cutting-edge science, digitalisation and more sustainable ways of operating. You will have the freedom to take ownership, influence outcomes and help shape reliable commercial manufacturing for important biologic medicines. If you are a curious problem-solver who thrives in a fast-moving, complex environment and wants to accelerate growth while making people's lives better, this could be the place for you. The opportunity As Drug Substance Tech Transfer Lead, you will lead drug substance technology transfer activities across the biologics portfolio. You will support Global CMC deliverables and enable robust, reliable commercial manufacturing across internal and external networks. Your primary focus will be post-approval drug substance technology transfers, including antibody-drug conjugates (ADCs). You will also support new product introduction (NPI) transfers, bringing an Operations perspective to scale-up, transfer readiness and long-term manufacturability.

Requirements

Technically credible, operationally minded leader with experience in biologics drug substance manufacturing and CMC.
Significant experience in CMC, drug substance manufacturing, MS&T or a related biologics technical operations role.
Working knowledge of upstream, downstream and conjugation processes, with sufficient technology transfer understanding to support strategy, execution and issue resolution.
Experience supporting biologics portfolios with diverse modalities and understanding the technical and operational considerations involved in transfer and commercialisation.
Experience leading or supporting post-approval drug substance transfers, ideally including ADCs.
Experience supporting NPI transfers and contributing a strong Operations perspective to commercial manufacturing readiness.
Strong understanding of internal and external manufacturing capabilities, including technical fit, site readiness, operational maturity and transfer risk.
Good understanding of GMP operations, quality systems and regulatory expectations relevant to biologics drug substance manufacturing and transfer.
Demonstrated ability to influence in a matrix organisation and deliver through collaboration across functions, sites and external partners.
Strong leadership, communication, problem-solving, risk-management and execution skills in complex technical environments.
The ability to challenge current approaches and an interest in, or experience with, digital technology transfer.
Bachelor's, Master's or PhD in Biochemical Engineering, Chemical Engineering, Biotechnology, Biology, Pharmaceutical Sciences or a related discipline.
8+ years of relevant experience in CMC matrix leadership, drug substance manufacturing, technology transfer, biologics process development, MS&T or a related pharmaceutical or biologics operations role.

Nice To Haves

Direct technology transfer experience is an advantage.

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.