Scientist I-Analytical, Research & Development (ARD)

Role Overview

The Analytical Scientist 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 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.

Qualifications

• BS in Analytical chemistry or equivalent with 10+ years related experience in analytical development (R&D and method qualification/validation) environment within pharmaceutical industry.
• MS in Analytical chemistry or equivalent with 8+ 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.

Pay

The salary range for this role is $90,000-105,000 annually. This range represents a good-faith estimate of the compensation we expect to offer for this position at the time of posting. Actual compensation will be based on factors such as relevant experience, skills, qualifications, and internal equity. In exceptional cases, compensation may exceed the stated range.

Schedule

All full-time employees are eligible to participate in our annual incentive bonus program. Bonus targets vary by career level and are based on individual and company performance.