Principal Scientist-Analytical Research & Development (ARD)

Core Responsibilities

• Lead the design, development, and execution of phase-appropriate analytical methods in compliance with ICH and Health Authority guidelines.
• Independently, detects and solves complex problems of high technical difficulty.
• 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.
• Prepares and reviews scientific reports for both internal and external entities.
• Maintain and troubleshoot analytical instrumentation.
• Act as a technical point of contact for clients, providing project updates and solving technical challenges in real time.
• Contribute to audit readiness and participate in quality audits with FDA, other Regulatory Agencies, and customers, as needed.
• Ensure work in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.

Qualifications

• PhD in Analytical Chemistry or equivalent with more than 8 years’ experience in a GMP environment.
• MS in Analytical Chemistry or equivalent with more than 10 years’ experience in a GMP environment.
• Minimum of 8 years’ experience in method development and validation for Active Pharmaceutical Ingredients (APIs).
• Experience with Process Development of APIs.
• Minimum 3 years of experience in oligonucleotides and/or peptides.
• Experience with common analytical techniques such as: HPLC/UPLC, GC, NMR, UV, KF, FTIR, XRPD, LC-MS, GC-MS and ICP-MS.

Pay

The salary range for this role is $140,000-$155,000. 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

Full-time position.