GMP Analytical Method Transfer Scientist

Avecia Pharma

Milford (MA)

On-site

USD 93,000 - 114,000

Full time

4 days ago
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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

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

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