The Scientist Group Leader is responsible for the development and implementation of analytical procedures and specifications in support of the development and manufacture of active pharmaceutical ingredients (APIs) for traditional synthetic molecules (including potent) and peptides. Primary analytical techniques include chromatography (HPLC/UPLC, GC, and IC), Spectroscopy (LC-MS, GC-MS, NMR, ICP-MS, FTIR and UV-Vis), and physical properties (particle size, water content, etc.). Core 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 forboth 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.
• Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
• Ensures work in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.

• BS in Analytical chemistry or equivalent with 5+ years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
• MS in Analytical chemistry or equivalent with 3+ years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
• PhD in Analytical chemistry or equivalent with related experience in analytical development (R&D and method qualification/validation) environment within 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 Active Pharmaceutical Ingredients (APIs). Experience with Process Development of APIs.
• Previous leadership experience preferred 

The position is full-time, Monday-Friday, 8:00am-5:00pm, with overtime as needed. Candidates living within a commutable range of Devens, MA are encouraged to apply. 

• Compensation: $84,000-94,000
• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

 

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.