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

Drug Substance Tech Transfer Lead

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.

What you will do

• 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.

What you will bring

You are a technically credible, operationally minded leader with experience in biologics drug substance manufacturing and CMC. You can connect technical detail with the practical realities of site readiness, transfer execution and lifecycle management, while building alignment across internal and external networks.

• 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. Direct technology transfer experience is an advantage.
• 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.

Education and experience

• 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.

Leadership in this role

You will operate as a trusted technical and operational leader who can translate Global CMC requirements into effective transfer strategies and executable plans. Success will require sound judgment, resilience and the ability to balance technical, quality, supply and business priorities.

You will be expected to represent Operations effectively, build alignment across a broad matrix, lead high‑quality transfer execution and continuously improve how drug substance technology transfer is delivered.

Why Operations?

• Purpose with impact: help bring medicines to patients by turning a science‑led pipeline into reliable supply.
• Meaningful ownership: step up, lead and drive outcomes in an environment where good can always be better.
• Global collaboration: work across an international manufacturing network and with diverse technical and operational partners.
• Growth and learning: broaden your expertise across modalities, sites and lifecycle stages while contributing to new digital ways of working.
• Progress at pace: help advance Lean, automation, digitalisation and sustainable practices across Operations.

Ready to make an impact?

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

The annual base pay for this position ranges from $138,392.80 to $207,589.20. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

Date Posted

14-sept-2026

Closing Date

04-oct-2026