The Scientist Analytical Development role focuses on developing, optimizing, and troubleshooting analytical methods for large molecule therapeutics and lipid nanoparticle systems. This position supports both discovery and CMC development programs, contributing to analytical strategy and regulatory documentation to enable IND submissions and ensure GMP compliance.

Responsibilities:

• Design and refine analytical methods for characterizing mRNA, siRNA, LNPs, and Antibody Oligo Conjugates, focusing on purity, integrity, potency, and stability.
• Develop and implement stability-indicating methods for both drug substances and drug products.
• Facilitate analytical method transfer, qualification, and validation activities with external partners and contract laboratories.
• Draft, review, and finalize method qualification protocols, analytical procedures, and validation summaries for regulatory submissions.
• Review and approve specification documents, certificates of analysis, and stability protocols to ensure regulatory alignment.
• Assess analytical method suitability, system suitability criteria, and method transfer documentation from external sources.
• Collaborate with quality and regulatory teams to ensure documentation meets phase-appropriate standards and supports GMP compliance.
• Act as a technical liaison across discovery, formulation, process development, and quality teams to advance analytical strategies from early research through IND-enabling activities.

Qualifications:

• PhD (1–3 years industry experience), or BS/MS (5–8 years industry experience) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Hands-on industry experience in analytical method development for large molecules such as mAbs, nucleic acids, or LNP-based therapeutics.
• Strong knowledge of chromatographic and electrophoretic techniques, including HPLC, UPLC, CE, and LC-MS.
• Experience authoring and reviewing CMC regulatory documents, such as method qualification protocols, analytical procedures, or validation reports.
• Familiarity with ICH guidelines (Q2, Q6B, Q14) and phase-appropriate analytical expectations.
• Ability to work independently in a fast-paced, cross-functional environment.
• Direct experience at the Analytical Development/Quality Control interface in a biotech or pharma setting is a plus.
• Experience supporting IND-enabling CMC programs, including analytical sections of Module 3 CTD submissions, is preferred.
• Familiarity with GMP laboratory operations and documentation practices is advantageous.
• Experience with analytical method transfer to contract laboratories is desirable.
• Track record of successfully authoring method qualification/validation protocols that passed regulatory review is a plus.

Published Category:

Analytical & Process Development