Scientist, ASAT

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 $93300 - $113800.