Your primary focus will be on designing, executing, and optimizing upstream Lentiviral Vector (LVV) processes with a primary focus on suspension bioreactor platforms at clinical and commercial scales. You will contribute hands-on to experimental design, process characterization, and scale-up/tech transfer activities from research through IND enabling, partnering closely with Research, Analytical Development, CMC, Regulatory, Manufacturing, Quality, and external CDMOs.

Key Responsibilities:

• Plan and perform experiments to develop and optimize LVV upstream processes for suspension cell culture (transient or stable producer cell systems), targeting improvements in titer, quality, robustness, and cost.

• Execute unit operations across seed, production, and harvest interfaces; support scale-up strategies from bench to pilot and clinical scales; develop and use scale-down models for characterization and comparability.

• Design DOE studies, identify CPPs/CMAs, analyze data, and propose control strategies; document results in protocols and reports; maintain fit for-purpose knowledge records.

• Contribute to definition of design space, in-process controls, and operating ranges; trend process performance and drive troubleshooting, root cause analysis, and corrective actions.

• Prepare technical transfer packages and support transfers to internal GMP sites and CDMOs; align process documentation with cGMP principles for late-stage readiness.

• Work closely with Analytical Development on assay readiness and in process testing; partner with Manufacturing, Supply, and Quality to ensure operational feasibility and compliance.

• Apply Lean practices and digital tools for scheduling, data integrity, and reproducibility; track KPIs (titer, infectivity, impurity profiles, cycle time, right first time) and recommend improvements.

Qualifications:

• Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 1+ years of industry experience; OR M.S. with 4+ years; OR B.S. with 5+ years of hands-on industry experience.

• Experience: Hand-on experience developing suspension-based LVV upstream processes; familiarity with clinical/commercial scale considerations, process characterization, and technology transfer.

• Technical Skills: Proficiency in suspension cell culture, transfection/infection strategies, media/feed optimization, single-use rocking-platform and stirred-tank bioreactors, and upstream-harvest interfaces; working knowledge of statistical DOE and data analytics tools.

• GMP Readiness: Experience supporting cGMP interfaces (documentation, change control, sampling plans) and contributing to CMC sections or technical responses is a plus.

• Communication & Teamwork: Strong written and verbal communication skills; ability to work effectively in cross-functional, matrixed teams; demonstrated problemsolving and troubleshooting capability.

• Tools & Automation: Experience with single-use systems, process automation/PAT, and digital lab systems (ELN/LIMS) preferred.

Preferred Qualifications:

• Demonstrated success scaling suspension LVV processes to pilot/clinical scales and sustaining performance via monitoring and continuous improvement.

• Experience linking upstream parameters to analytical outcomes (titer, infectivity/potency, residuals/impurities) to guide process decisions.

• Contributions to regulatory filings (data tables, process descriptions) and participation in tech transfer to CDMOs or internal GMP sites.

• Experience implementing Lean/continuous improvement and robust documentation/knowledge management in PD labs.

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This role focuses on the development and deployment of global category strategies and initiatives, leading our major supplier relationships, developing deeper relationships with the various stakeholder groups through effective business partnering, and ensuring that the underpinning process improvement and procurement activities deliver the expected business value.

In this role, you will develop long-term strategic plans for an entire spend category within AstraZeneca. You will manage stakeholder and supplier relationships to ensure that category strategies are highly aligned to current and future business needs and that the supply base can support these strategies.

Responsibilities:

• Lead implementation of category plans to ensure that the underpinning process improvement and procurement activities deliver business value in accordance with the strategic plan and help towards our Sustainability targets.

• Develop long term strategic plans for agreed scope of spend area, with a focus on delivering broader value, innovation, and savings.

• Support the team in strategic relationship management (customer and supplier) - ensuring Category Strategies are fully aligned to current and future Business need, and we maintain a supply base capable of supporting these strategies.

• Work alongside key stakeholders advising on and driving procurement strategies to make decisions necessary to make purchases in congruence with organizational objectives.

• Advise on contracts and agreements for the supply of sophisticated products and services with new and existing suppliers - Cross functional support of global procurement colleagues and collaborate on setting and completing the strategy.

• Develop and execute alliance management strategies for key CDMO partnerships - Lead sourcing and negotiation for Auto TCR-T, Allo CAR-T, and In-vivo manufacturing - Drive COGM reduction initiatives for LVV, Plasmids, Gene Editing, and Drug Product - Build resilient, multi-source supplier base for critical materials in collaboration with technical, quality, and external manufacturing teams

Essential Qualifications:

• Bachelor’s degree or equivalent

• 7+ years of experience in a procurement environment

• Significant experience of Category Management (preferably in Cell Therapy)

• Strong project management, change management and people leadership skills

• Strong understanding of the pharmaceutical industry

• Strong communication skills and ability to influence others

• Comfort with risk and ambiguous situations

Preferred Skills:

• Proven track record negotiating and managing complex CDMO contracts

• Technical background (ideally MS&T, CMC, or manufacturing engineering)

• Strong alliance management skills balancing cost, quality, and relationship dynamics

• Experience with novel modalities (CAR-T, TCR-T, in-vivo gene editing)

• Track record managing tech transfers to CDMOs

• Familiarity with Lean/Six Sigma methodologies

• China market experience: Deep understanding of China's biotech ecosystem, regulatory environment, and supplier landscape. Mandarin language proficiency (for China-focused role)

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