HPLC Oligonucleotide Method Development & Validation

Eurofins

Lancaster (Lancaster County)

On-site

USD 90,000 - 120,000

Full time

9 days ago

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Benefits offered by this job

Medical, dental, vision benefits
Life and disability insurance
401(k) with company match
Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services in Lancaster, PA seeks an Oligonucleotide Scientist to develop, validate, and execute analytical methods for oligonucleotide API, drug substance, and drug product testing. The role focuses on HPLC/UHPLC and mass spectrometry for identity, purity/impurity profiling, quantitation, and stability indicating assessments.

The candidate will author methods, ensure data integrity in GMP environments, mentor junior staff, and collaborate with clients.

Qualifications

  • BS or MS in Analytical Chemistry or related discipline.
  • 4+ years with BS; 2+ years with MS; 1+ year with PhD in relevant field.
  • Experience with oligonucleotide testing in GMP environments.
  • Authorization to work in the U.S. indefinitely without restriction or sponsorship.

Responsibilities

  • Develop, validate, and execute analytical methods for oligonucleotide testing (HPLC, GC, UV/Vis, dissolution).
  • Read and interpret diverse analytical procedures; conduct investigations.
  • Troubleshoot instrumentation and communicate with vendors as needed.
  • Train and mentor junior staff; manage projects and interact with clients; ensure GMP/GxP compliance.

Skills

Excellent communication
Teamwork
Detail-oriented
Self-motivated

Education

BS or MS in Analytical Chemistry

Tools

HPLC
UHPLC
IEX
SEC
Mass spectrometry

Job description

Company 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.

Company 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
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.

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