Lead Analytical Scientist – API Method Development

LabRulez; Massachusetts; Ibrido; USD 84.000 - 94.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Descrizione del lavoro

Eurofins USA PSS Insourcing Solutions is seeking a Scientist Group Leader in Devens, MA. The role focuses on developing and implementing analytical methods for APIs using HPLC/UPLC, GC, NMR, UV-Vis, LC-MS and related techniques. Lead and train teams while ensuring regulatory compliance and audit readiness.

The position is full-time, with standard hours and potential overtime. Salary ranges are provided, and excellent benefits accompany this role.

Competenze

• BS in Analytical chemistry or equivalent with 5+ years related experience in analytical development in pharmaceutical industry.
• MS in Analytical chemistry or equivalent with 3+ years related experience in analytical development in pharmaceutical industry.
• PhD in Analytical chemistry or equivalent with related experience in analytical development in pharmaceutical industry.
• Experience with common analytical techniques such as: HPLC/UPLC, GC, NMR, UV, KF, FTIR, XRPD, LC-MS, GC-MS and ICP-MS.
• Minimum of 5 years’ experience in method development and validation for small molecules APIs; API process development experience.
• Previous leadership experience preferred.

Mansioni

• Lead design, development, and execution of phase-appropriate analytical methods in compliance with ICH guidelines.
• Perform release and stability testing on starting materials, intermediates and API for development and GMP samples.
• Author and review 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 other regulators as needed.
• Ensure work complies with GMP, DEA, FDA, and related regulations.

Formazione

BS in Analytical chemistry

MS in Analytical chemistry

PhD in Analytical chemistry

Method development experience

Validation/qualification experience

Leadership experience

Regulatory/compliance understanding

Strumenti

HPLC/UPLC

GC

NMR

UV-Vis

FTIR

ICP-MS

ICP-OES

LC-MS

XRPD

KF

Descrizione del lavoro

Eurofins USA PSS Insourcing Solutions is seeking a Scientist Group Leader in Devens, MA. The role focuses on developing and implementing analytical methods for APIs using HPLC/UPLC, GC, NMR, UV-Vis, LC-MS and related techniques. Lead and train teams while ensuring regulatory compliance and audit readiness.

The position is full-time, with standard hours and potential overtime. Salary ranges are provided, and excellent benefits accompany this role.