HPLC Oligonucleotide Method Development & Validation

Location: Lancaster, PA, USA; onsite and not remote. Candidates must be within a commutable distance of Lancaster, PA. Unrestricted U.S. work authorization without sponsorship is required. The role is full-time, first shift, Monday–Friday, 8:00 a.m.–4:00 p.m.; 25% travel may be required.

Company

hirify.global provides analytical testing and contract research services across pharmaceutical, food, environmental, cosmetic, genomics, and other life sciences sectors.

What you will do

• Develop, optimize, validate, and execute analytical methods for oligonucleotide APIs, drug substances, and drug products.
• Perform testing using HPLC, UHPLC, ion-exchange chromatography, size-exclusion chromatography, mass spectrometry, GC, UV/Vis, and dissolution procedures.
• Assess identity, purity, impurities, quantitative results, and stability-indicating characteristics.
• Author analytical methods, protocols, reports, and accurate laboratory records in GxP environments.
• Conduct investigations, troubleshoot instrumentation, and communicate with vendors when required.
• Manage client projects, provide technical leadership, and mentor junior staff.

Requirements

• BS or MS in Analytical Chemistry or a related scientific discipline; relevant industry experience of 4+ years with a BS, 2+ years with an MS, or 1+ year with a PhD.
• Experience performing analytical testing with oligonucleotides in a GMP-regulated environment.
• Strong theoretical and practical knowledge of HPLC, UHPLC, IEX, SEC, and mass spectrometry, including method development, validation, and routine testing.
• Familiarity with ICH guidelines and GxP regulatory standards.
• Background primarily in analytical testing or analytical method development; primarily synthetic or process chemistry experience without analytical or QC responsibilities will not be considered.
• Authorization to work in the U.S. indefinitely without restriction or sponsorship is required.

Culture & Benefits

• Full-time onsite laboratory work with a structured first-shift schedule.
• Comprehensive medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.