Scientist II-Analytical, Research & Development (ARD)

Veranova • Devens, MA

2d

About The Position

The Analytical Scientist II 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.).

Requirements

• BS in Analytical chemistry or equivalent with 12+ years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
• MS in Analytical chemistry or equivalent with 10+ years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
• PhD in Analytical chemistry or equivalent with 3+ years 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.

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 both 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.

Benefits

• Comprehensive health & wellness benefits.
• Access to mental health resources and wellness programs.
• Generous PTO and holiday pay policies.
• Eligibility for performance-based bonuses.
• Attractive 401(k) Plan with company match.
• Opportunities for continuous learning through LinkedIn Learning, workshops, conferences, and mentorship.
• Tuition Assistance for Undergraduate and Graduate degree programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level