About this opportunity :

Key Responsibilities:  

• Support analytical method transfers from clients, AD, and cross-site laboratories into QC, including readiness assessments, implementation activities, training support, and deployment into GMP operations.
• Execute laboratory activities associated with method transfer, qualification, verification, co-validation, and implementation while ensuring accurate documentation and GMP compliance.
• Assist in developing and maintaining method transfer requirements, risk assessment tools, implementation resources, and laboratory informatics solutions.
• Provide technical training, shadowing, and coaching for QC analysts during implementation and routine execution activities.
• Troubleshoot chromatographic, mass spectrometric, and related analytical methods and instrumentation under the guidance of senior technical staff.
• Support deviations, OOS, OOT, PAC failures, data invalidations, and atypical investigations through data review, troubleshooting, hypothesis generation, and investigation execution.
• Evaluate root causes, support CAPA development, and escalate complex issues as needed.
• Assist with collection and review of method performance data, transfer metrics, investigation outcomes, and recurring laboratory issues to support trend analysis and continuous improvement.
• Support ASAT tracking tools, dashboards, templates, documentation systems, and laboratory informatics solutions, including LIMS methods and workflows.
• Author and revise protocols, reports, training materials, technical assessments, method implementation documents, and other GMP documentation.
• Execute in-process, release, stability, and reference material testing as needed.

Required Skills/Abilities: 

• BA/BS with 5+ years, MS with 3+ years, or PhD with 0-3 years of experience in AD, QC, or related analytical functions within the pharmaceutical or biotechnology industry, preferably within a CDMO.
• This role serves as a cross-site technical resource and may require up to 10% travel.
• Experience working with chromatographic, mass spectrometric, or related analytical technologies.
• Familiarity with analytical method transfer, testing, or implementation activities in a GMP environment.
• Familiarity with analytical techniques used for oligonucleotide characterization and testing.
• Experience using analytical instrumentation and software platforms, including Agilent, Waters, or equivalent systems.
• Experience authoring GMP documentation, including SOPs, methods, protocols, reports, and training documents.
• Familiarity with deviations, OOS, OOT, CAPA activities, and root cause investigation principles.
• Knowledge of GMP regulations, ICH guidelines, pharmacopeial requirements, data integrity principles, and laboratory compliance expectations.

The annualized salary range for this role is $93,300 - $113,800.