The ASAT Scientist supports analytical method transfer, laboratory implementation, analyst training, and lifecycle management for oligonucleotide clinical and commercial programs. This role partners with Quality Control (QC), Analytical Development (AD), Manufacturing, Quality Assurance, and clients to ensure analytical methods are successfully transferred, implemented, and executed in GMP laboratories. The position provides hands-on laboratory support while developing expertise in analytical technologies, method lifecycle management, and technical leadership.
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.
