HPLC Oligonucleotide Method Development & Validation

Eurofins BioPharma Product Testing North America; Lancaster (Lancaster County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services is seeking an Oligonucleotide Scientist to develop and validate analytical methods for oligonucleotide API, drug substance, and drug product testing. The role emphasizes HPLC/UHPLC and mass spectrometry for identity, purity, and stability assessments, with data integrity and GMP compliance as core requirements.

You will author methods and reports, mentor junior staff, and interact with pharmaceutical clients throughout the drug development pipeline.

Qualifications

• BS or MS in Analytical Chemistry or related scientific discipline.
• BS: 4+ years; MS: 2+ years; PhD: 1+ year of relevant industry experience.
• Experience performing analytical testing with oligonucleotides in GMP environment.
• Strong knowledge of chromatography and mass spectrometry, method development and validation.
• Authorization to work in the U.S. indefinitely without sponsorship.

Responsibilities

• Develop, optimize, validate and execute analytical methods for oligonucleotide testing.
• Focus on HPLC/UHPLC and mass spectrometry for identity and purity profiling.
• Author methods, protocols and reports; ensure data integrity in GxP environments.
• Provide technical leadership and mentor junior staff.
• Manage projects and discuss results with clients; troubleshoot instrumentation.

Skills

Analytical Chemistry

Regulatory/GxP knowledge

Communication

Teamwork

Attention to detail

Education

BS in Analytical Chemistry

MS in Analytical Chemistry

Tools

HPLC

UHPLC

GC

UV/Vis

Dissolution

Mass spectrometry

IEX

SEC

Job description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2024, Eurofins generated total revenues of EUR € 6,515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

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., 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

Ideal Candidate

• 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.