Oligonucleotide Method Development & Validation

**Applicants MUST have authorization to work in the U.S. indefinitely without restriction or sponsorship.**

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. LCMS LCMS/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

Additional Information :

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. 

What we Offer:

• 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

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time