Lead Analytical Scientist – Drug Control Strategy & Methods

AstraZeneca; Macclesfield; On-site; GBP 85,000 - 110,000; Full time

Job summary

AstraZeneca Macclesfield seeks an experienced Analytical Lead to shape and deploy analytical control strategies across drug development. You will design, validate and transfer analytical methods (HPLC/UPLC, LC–MS), lead stability programs and author CMC content for IND/MAA submissions, while collaborating with cross-functional teams to ensure regulatory success.

Strong data analytics, DoE, and statistical tool proficiency are essential, as is the ability to mentor colleagues and drive continuous

Qualifications

• MSc or PhD in Analytical Chemistry, Pharmaceutical Sciences or related field.
• Experience in pharmaceutical analytical science with regulatory CMC knowledge.
• Strong chromatography experience (HPLC/UPLC, LC–MS) and dissolution methodologies.
• Excellent communication and cross-functional collaboration skills.
• Ability to drive data-driven decisions and troubleshoot issues.
• Fundamental digital data capabilities and DoE concepts.

Responsibilities

• Lead analytical control strategy development and lifecycle management.
• Define end-to-end analytical strategies across clinical phases.
• Design/validate/transfer analytical methods (HPLC/UPLC, LC–MS).
• Lead stability programmes and inform formulation choices.
• Author CMC analytical content for regulatory submissions and responses.
• Collaborate with formulators, engineers, and manufacturing for tech transfers.
• Lead investigations and ensure data integrity and GxP compliance.
• Apply multivariate design and DoE for method development and analytics.
• Provide governance and mentorship within the analytical team.

Skills

Analytical leadership

Regulatory interaction

Data-driven decision making

Stakeholder management

Troubleshooting

Education

MSc/PhD in Analytical Chemistry or related

Tools

HPLC/UPLC

LC-MS

ELN/CDS

JMP

Minitab

Python/R (basic)

Job description

AstraZeneca Macclesfield seeks an experienced Analytical Lead to shape and deploy analytical control strategies across drug development. You will design, validate and transfer analytical methods (HPLC/UPLC, LC–MS), lead stability programs and author CMC content for IND/MAA submissions, while collaborating with cross-functional teams to ensure regulatory success.

Strong data analytics, DoE, and statistical tool proficiency are essential, as is the ability to mentor colleagues and drive continuous