Analytical Science & Technology Lead — Small Molecule

GlaxoSmithKline plc; Ware; In loco; GBP 120.000 - 150.000; Tempo pieno

Descrizione del lavoro

GlaxoSmithKline plc in the UK is seeking an Analytical Science and Technology Lead (ASTL) to drive end-to-end analytical strategy for late-stage product lifecycle. You will lead comparability studies, method transfers and critical investigations impacting regulatory submissions and market supply.

The role requires strong leadership, cross-functional collaboration across R&D, manufacturing and QA, and a track record in applying innovative analytical technologies to complex processes.

Competenze

• BS/MS in a scientific discipline (pharmacy, chemistry, biology or related field).
• Experience with analytical method development, validation and transfer.
• Experience in biopharmaceutical late-stage product and CQAs.

Mansioni

• Provide analytical leadership for programs, projects and activities to meet priorities such as NPI, product transfers, change management and regulatory submissions.
• Define and maintain comparability studies and acceptance criteria for release and stability tests.
• Input to comparability protocols and regulatory documents, considering non-routine data and regulatory expectations.
• Partner with R&D, manufacturing, regulatory and QA teams in a matrix to meet asset needs and mitigate risks.
• Drive evaluation of new analytical technologies, including PAT, for product control strategy.
• Support sites with analytical aspects of RCA investigations in complex post-approval investigations.
• Defend APS during HA inspections and regulatory reviews.

Conoscenze

CMC Strategy

Data-Driven Decision Making

Data Integrity

Debate Moderation

Digital Fluency

GxP Regulations

Lean Management

Problem Solving

Process Optimization

Project Leadership

Risk Awareness

Scientific Writing

Technology Transfer

Formazione

BS/MS in a scientific discipline (pharmacy, chemistry, biology or related field)

Descrizione del lavoro

GlaxoSmithKline plc in the UK is seeking an Analytical Science and Technology Lead (ASTL) to drive end-to-end analytical strategy for late-stage product lifecycle. You will lead comparability studies, method transfers and critical investigations impacting regulatory submissions and market supply.

The role requires strong leadership, cross-functional collaboration across R&D, manufacturing and QA, and a track record in applying innovative analytical technologies to complex processes.