Lead Analytical Scientist – API Development

Eurofins US Network; Harvard (MA); On-site; USD 84,000 - 94,000; Full time

Benefits offered by this job

Medical coverage (full) and dental/vis

Vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins US Network invites a Senior Scientist Group Leader in Devens, MA. You will lead development and validation of analytical methods for APIs and related compounds, using HPLC/UPLC, GC, NMR, LC-MS, and other techniques in a GMP environment.

You will author reports, supervise QA audits, and ensure compliance with GMP, FDA, and other regulations while managing a capable analytical team.

Qualifications

• BS in Analytical chemistry or equivalent with 5+ years related experience in analytical development (R&D and method qualification/validation) in pharmaceutical industry.
• MS in Analytical chemistry or equivalent with 3+ years related experience in analytical development (R&D and method qualification/validation) in pharmaceutical industry.
• PhD in Analytical chemistry or equivalent with related experience in analytical development (R&D and method qualification/validation) in pharmaceutical industry.

Responsibilities

• Lead the design, development, and execution of phase-appropriate analytical methods in compliance with ICH and Health Authority guidelines.
• Perform release and stability testing on starting materials, intermediates and API for development and GMP samples.
• Author and review technical documents including method qualification/validation/transfer protocols and reports for analytical procedures.
• Maintain and troubleshoot analytical instrumentation.
• Contribute to audit readiness and participate in quality audits with FDA and customers as needed.
• Ensure compliance with GMP, DEA, FDA and related regulations.

Skills

Analytical chemistry

Leadership

Education

BS in Analytical chemistry

MS in Analytical chemistry

PhD in Analytical chemistry

Tools

HPLC/UPLC

GC

NMR

UV

KF

FTIR

XRPD

LC-MS

GC-MS

ICP-MS

Job description

Eurofins US Network invites a Senior Scientist Group Leader in Devens, MA. You will lead development and validation of analytical methods for APIs and related compounds, using HPLC/UPLC, GC, NMR, LC-MS, and other techniques in a GMP environment.

You will author reports, supervise QA audits, and ensure compliance with GMP, FDA, and other regulations while managing a capable analytical team.