Scientist, ASAT

Avecia Pharma; Milford (MA); On-site; USD 93,000 - 114,000; Full time

Job summary

Avecia Pharma is seeking an ASAT Scientist to support analytical method transfer, laboratory implementation, analyst training, and lifecycle management for oligonucleotide programs. This role partners with QC, Analytical Development, Manufacturing, QA, and clients to ensure transfers are executed in GMP laboratories.

The position provides hands-on lab support while developing expertise in analytical technologies, method lifecycle management, and technical leadership, with up to 10% travel to

Qualifications

• BA/BS with 5+ years, MS with 3+ years, or PhD with 0-3 years in AD, QC, or related analytical functions in pharma/biotech.

Responsibilities

• Support method transfers from clients and cross-site labs into QC.
• Execute lab activities for transfer, qualification, verification, and implementation with GMP documentation.
• Assist in developing transfer requirements, risk assessments, and lab informatics solutions.
• Provide training, shadowing, and coaching for QC analysts during implementation.
• Troubleshoot chromatographic and mass spec methods under senior guidance.
• Support deviations, OOS, OOT, CAPA investigations and data review.
• Evaluate root causes, support CAPA, and escalate complex issues.
• Assist with collection/review of performance data and transfer metrics for trend analysis.
• Support ASAT tracking tools, dashboards, and LIMS workflows.
• Author and revise GMP documents including SOPs, methods, and reports.
• Execute in-process, release, stability, and reference material testing as needed.

Skills

Analytical method transfer

GMP compliance

Chromatography

Mass spectrometry

Data integrity

Education

BA/BS in analytical sciences

MS in analytical sciences

PhD in related field

Tools

Agilent instruments

Waters instruments

Job description

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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 elevate 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.