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Principal Specialist, Data Review Analytical Method Development

salary Salary :

₹6.95 monthly

icon building Company : Eurofins
icon briefcase Job Type : Full Time

Number of Applicants

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Job Description - Principal Specialist, Data Review Analytical Method Development

Company Description

Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.

Group's key figures are approx. 6.95 billion Euros turnover, over 950 laboratories across 60 countries and about 63,000 staff.

Job Description

Key Responsibilities

  • Independently review analytical method development data, protocols, reports, and supporting documentation to ensure accuracy, completeness, and scientific soundness.
  • Evaluate chromatographic method development strategies, experimental design, and data interpretation for alignment with client expectations and regulatory requirements.
  • Verify analytical data, including chromatographic outputs (e.g., HPLC, GC, IC, GCMS, LCMS), calculations, system suitability, and method performance characteristics.
  • Ensure all work complies with GMP, data integrity principles (ALCOA+), internal SOPs, and applicable regulatory guidelines (e.g. ICH).
  • Identify discrepancies, errors, or gaps in data and documentation, and drive resolution with appropriate stakeholders.
  • Partner with Analytical Scientists and Project Group Leaders to ensure accurate interpretation and reporting of method development work.
  • Provide client support as needed by offering technical insight and clarification related to data review findings.
  • Serve as a technical resource for junior reviewers and scientific staff, providing guidance on data review practices and regulatory expectations.
  • Contribute to the development and refinement of review procedures, best practices, and training materials.

Qualifications

Qualifications Required: 

  • Master’s degree in a scientific discipline (Chemistry or related field).
  • Minimum of 10 years of industry experience, including at least 5 years in analytical method development.
  • Strong scientific understanding of analytical techniques and instrumentation (e.g., HPLC, GC, IC, dissolution, mass spectrometry).
  • Strong understanding of chromatographic method principles, including impurity analysis, peak purity evaluation, forced degradation, method specificity, selectivity, resolution, robustness, accuracy, precision, linearity, and sensitivity.
  • Proven ability to interpret complex scientific data, review protocols, and analytical reports.
  • Exceptional attention to detail and commitment to data accuracy and integrity.
  • Strong communication skills with the ability to collaborate effectively and provide clear, constructive feedback.
  • Experience with data integrity expectations and regulated laboratory environments.
  • Familiarity with electronic systems such as LIMS, ELN, Empower, Mass Hunter.

 

Additional Information

Key Candidate Attributes:

  • Self-motivation; excellent quality of work and attention to detail
  • Ability to communicate effectively with coworkers and internal/external clients
  • Ability to learn new tasks quickly and to move easily from task to task
  • Ability to handle prioritization and multiple tasks simultaneously
  • Ability to use a personal computer and learn necessary programs
  • Good communication skills (oral and written)
  • Organizational ability and good judgement
  • Science background/education and/or laboratory experience
  • Strong Math Skills
  • Logical Thinking, Good Reasoning Ability
  • Motivation to excel
  • Coaching/mentoring of peers
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