GMP Analytical Method Transfer Scientist

Avecia Pharma; Milford (MA); Hybrid; 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

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%.