Analytical Science & Technology Lead (ASTL) - Small Molecule
Core
Lead analytical science and technology for late-phase product lifecycle, managing comparability studies, characterization strategies, and post-approval changes for small molecule products.
Role type
Senior Analytical Science & Technology Lead (Small Molecule)
Builds
Analytical Product Strategy (APS) and comparability protocols for regulatory submissions and technical transfers.
Domain
Biopharmaceuticals / Small Molecule Manufacturing
Required skills
Analytical method development and validation, Technical transfer, Regulatory file authoring (IND, IMPD, BLA, MAA), Critical Quality Attribute (CQA) assessment, Drug substance and drug product manufacturing knowledge, Post-approval change management, Stakeholder management, Risk mitigation, Root cause analysis, New technology evaluation (PAT)
Preferred skills
Statistics (CPV, test method equivalence, specification setting), Product lifecycle knowledge (TRA, PPQ, CPV)
Technologies
PAT (Process Analytical Technology), GxP Regulations
Responsibilities
Provide technical analytical leadership for NPI, product transfers, and change management; Manage and update Analytical Product Strategy (APS) through the product lifecycle; Define comparability studies and characterization strategies for post-approval changes; Provide analytical input into comparability protocols and regulatory submissions; Partner with cross-functional teams (R&D, Technical, Regulatory) to mitigate risks; Embed method knowledge into technical transfers to internal and external sites; Support root cause analysis investigations; Defend APS during health authority inspections.
Seniority
Senior, hands-on IC with leadership responsibilities
