Job Description

We seek a highly motivated and experienced Analytical Scientist to join our team as a Scientist I. The ideal candidate will independently develop and optimize innovative methods and techniques to generate reliable, reproducible data efficiently. A solid understanding of core disciplines is essential to support the early-phase development of New Chemical Entities (NCEs) and New Biological Entities (NBEs) in compliance with GLP and GMP guidelines. Collaboration with our global Analytical R&D organization and cross-functional partners, including Pre-Clinical Safety (PCS), Process Chemistry, Process Engineering, Formulation R&D, and Quality Assurance (QA), is paramount.

Responsibilities:

Demonstrate technical knowledge and expertise in method development, validation, and routine characterization of drug substances and drug products using analytical techniques such as HPLC, GC, and LC-MS.

Highly autonomous and creative in designing experiments, interpreting results, drawing conclusions and conducting follow-on experiments based on multidisciplinary data.

Documents, verifies experimental activities and results in a GxP compliant manner using an electronic data acquisition and management systems.

Experienced in writing protocols/reports driving high quality and fit for purpose regulatory submissions.

Independently troubleshoots experiments, instrumentation and develops junior team members with minimal direction from the supervisor.

May assume the GLP Principal Investigator (PI) responsibilities and author GLP analytical phase reports. Reviews supporting data for consistency.

Able to initiate laboratory investigations (LIRs) and document other CAPA events with minimum supervision.

Understands and adheres to corporate standards regarding code of conduct, safety, appropriate handling of materials and GxP compliance, where applicable.

Supervision

May require staff and project supervision