Scientist, ASAT

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

Job summary

Avecia Pharma seeks an ASAT Scientist to support analytical method transfers, lifecycle management, and GMP operations in their oligonucleotide programs. You will partner with QC, Analytical Development, Manufacturing, QA, and clients to ensure successful transfer and implementation of analytical methods.

Responsibilities include hands-on lab support, training, and documentation. Requires 5+ years in AD/QC or similar, knowledge of chromatography or MS, and willingness to travel up to 10%.

Qualifications

• BA/BS with 5+ years, MS with 3+ years, or PhD with 0-3 years of experience in AD, QC, or related analytical functions in pharma/biotech.
• Cross-site technical resource; may require up to 10% travel.
• Experience with chromatographic or mass spectrometric analytical technologies.
• Familiarity with analytical method transfer, testing, or implementation in GMP environments.
• Experience authoring GMP documentation (SOPs, methods, protocols, reports).

Responsibilities

• Support analytical method transfers from clients, AD, and cross-site laboratories into QC, including readiness assessments and deployment into GMP operations.
• Execute laboratory activities for transfer, qualification, verification, co-validation, and implementation with proper documentation.
• Assist in developing transfer requirements, risk tools, and lab informatics solutions.
• Provide technical training, shadowing, and coaching for QC analysts during implementation.
• Troubleshoot chromatographic, mass spectrometric, and related methods under senior guidance.
• Support deviations, OOS, OOT, CAPA investigations with data review and root-cause analysis.
• Evaluate root causes, support CAPA development, and escalate complex issues.
• Assist with collection and review of method performance data and transfer metrics for trend analysis.
• Support ASAT tracking tools, dashboards, and LIMS workflows; author protocols and GMP docs.
• Execute in-process, release, stability, and reference material testing as needed.

Skills

Analytical method transfer

GMP compliance

Training & mentoring

Lab troubleshooting

Cross-site collaboration

Education

Bachelor's degree

Master's degree

PhD

Tools

Agilent instruments

Waters instruments

LIMS

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 escal 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.