HPLC Oligonucleotide Method Development & Validation

About the Role

The Oligonucleotide Scientist is responsible for developing, optimizing, validating, and executing analytical methods to support oligonucleotide API, drug substance, and drug product testing. The role supports pharmaceutical clients throughout various stages of the drug pipeline but does not support or include synthesis/manufacturing of oligonucleotides. The role focuses primarily on HPLC/UHPLC and mass spectrometry (e.g., LC-MS, LC-MS/MS) for identity, purity/impurity profiling, quantitation, and stability-indicating assessments. The scientist will author methods, protocols and reports, ensure data integrity and compliance within GxP environments, and provide technical leadership for routine testing and investigations and mentoring of junior staff.

Responsibilities

• Perform a large variety of analytical tasks for the validation of analytical methods used in the testing of drug products and raw materials by means of various procedures including HPLC, GC, UV/Vis, and dissolution
• Read, understand, and interpret diverse analytical procedures
• Conduct analytical investigations
• Troubleshoot instrumentation and communicate with vendors when required
• Train and mentor junior staff in laboratory procedures
• Manage and discuss projects with clients
• Apply GMP in all areas of responsibility, as appropriate

Qualifications

The Ideal Candidate would possess:

• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Minimum Qualifications:

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

Schedule

Working schedule will be Full-Time, First Shift, Mon-Fri, 8am-4pm. Candidates currently living within a commutable distance of Lancaster, PA are encouraged to apply. 25% travel may be required. This position is NOT remote.

Benefits

• 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