Analytical Strategy Lead – Biopharma, PAT & Innovation

AstraZeneca; Singapore; On-site; SGD 180,000 - 240,000; Full time

Job summary

AstraZeneca plc in Singapore seeks an experienced analytical science leader to define strategy for testing, method robustness, and regulatory submissions. You will partner across operations, QbD, and regulatory teams to ensure high-quality analytical content.

The role emphasizes deployment of PAT, data analytics, and continuous improvement, with leadership in post-approval changes and support for global regulatory interactions.

Qualifications

• Solid experience in analytical science, development, QC, or CMC in biopharma.
• Experience supporting regulatory submissions including BLA.
• Proficient in evaluating method robustness and comparability.
• Knowledge of PAT, inline/at-line analytics, or automation is advantageous.

Responsibilities

• Define end-to-end analytical strategy for assigned products, integrating commercialization, control strategy, supply continuity, and lifecycle requirements.
• Assess robustness and commercial readiness of analytical methods for transfer, validation, and routine use.
• Right-size analytical testing to maintain quality, safety, and compliance.
• Lead regulatory analytical content and responses for agency questions on methods and validation.

Skills

Analytical science

Analytical development

QC

CMC

Biopharmaceutical industry

Analytical strategy

Regulatory submissions

BLA

Statistics

Education

Degree in relevant scientific field

Advanced degree preferred

Tools

JMP

Job description

AstraZeneca plc in Singapore seeks an experienced analytical science leader to define strategy for testing, method robustness, and regulatory submissions. You will partner across operations, QbD, and regulatory teams to ensure high-quality analytical content.

The role emphasizes deployment of PAT, data analytics, and continuous improvement, with leadership in post-approval changes and support for global regulatory interactions.