GMP Analytical Method Transfer Scientist - Oligonucleotides

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

Job summary

Nitto Avecia in Milford, MA is seeking an ASAT Scientist to support analytical method transfer, laboratory implementation, analyst training, and lifecycle management for oligonucleotide programs in GMP laboratories.

You will partner with QC, Analytical Development, Manufacturing, QA and clients to ensure successful transfer and execution, provide hands-on lab support, and develop expertise in analytical technologies and method lifecycle management. Up to 10% travel may be required.

Qualifications

• Bachelors with 5+ years or MS with 3+ years in AD/QC or related analytical functions in pharma/biotech.
• Travel up to 10% may be required.
• Experience with chromatographic or MS technologies and GMP documentation.

Responsibilities

• Support analytical method transfers from clients, AD, and cross-site labs into QC operations.
• Execute method transfer activities: qualification, verification, co-validation and implementation.
• Develop and maintain method transfer requirements and risk assessment tools.
• Provide technical training and coaching for QC analysts during implementation.
• Troubleshoot analytical methods and instrumentation under senior guidance.
• Support deviations, OOS, OOT, CAPA investigations and data review.
• Contribute to method performance data collection and trend analysis.
• Author and revise GMP documents, protocols, reports, and training materials.
• Execute in-process, release, stability, and reference material testing as needed.

Skills

Chromatography

Mass spectrometry

GMP documentation

CAPA & root cause analysis

Cross-functional collaboration

Education

BA/BS + 5+ years

MS + 3+ years

PhD + 0-3 years

Tools

Agilent systems

Waters systems

Job description

Nitto Avecia in Milford, MA is seeking an ASAT Scientist to support analytical method transfer, laboratory implementation, analyst training, and lifecycle management for oligonucleotide programs in GMP laboratories.

You will partner with QC, Analytical Development, Manufacturing, QA and clients to ensure successful transfer and execution, provide hands-on lab support, and develop expertise in analytical technologies and method lifecycle management. Up to 10% travel may be required.