Job Summary
The Analytical Scientific Integrator serves as the Single Point of Contact (SPoC) for all analytical development (AD)–related activities supporting commercial and marketed products across the product lifecycle. This role provides strategic, scientific, and regulatory leadership for analytical aspects of post-approval change management, specification strategy, and lifecycle management of APIs, intermediates, starting materials, and drug products.
The position is accountable for translating project and lifecycle strategies into executable analytical plans, ensuring compliance with global regulatory expectations, compendial requirements, and internal quality standards. The role acts as an analytical expert and specification owner for assigned portfolios of established products and partners closely with cross‑functional technical teams, external manufacturing, and regulatory stakeholders.
Key Responsibilities
Skill Requirements
Strong expertise in analytical techniques (e.g., chromatography, spectroscopy, dissolution, compendial testing). Deep understanding of ICH guidelines (Q2, Q6, Q8, Q9, Q10) and global pharmacopeial requirements (USP, EP, JP). Risk-based approach to control strategy and specification justification. Solid knowledge of GMP, data integrity, and regulatory