Oligonucleotide Method Development & Validation

Job Summary:

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. Additional tasks/skills will include:

• Performing 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.
• Reading, understanding, and interpreting diverse analytical procedures.
• Conducting analytical investigations.
• Troubleshoot instrumentation and communicate with vendors when required.
• Train and mentor junior staff in laboratory procedures.
• Manage and discuss projects with clients.
• Applies 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
• Technical Expertise: Strong theoretical and practical knowledge of chromatography (HPLC, UHPLC, IEX, SEC) and mass spectrometry, including method development, validation, and routine testing
• Regulatory Knowledge: 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