Eurofins

Global lab testing and analytics network

Senior Specialist Data Review - Biologics, Large molecules

Regulatory & Quality (Life Sciences)Posted on Nov 13

Full-timeBengaluru, Karnataka, IndiaNo salary listedIn-person

About the Job

Requirements

A Master’s degree in a science-related field is required.
15–17 years of experience in Bio/Pharmaceutical drug product or substance testing, with knowledge of regulatory requirements, are required.
Theoretical or practical experience with ligand binding assays, ELISA, gel electrophoresis, proteomics, flow cytometry, TEM, PCR, cell culture, and cell-based assays (such as reporter gene, cell signaling, and cell proliferation) is required.
Knowledge of USP/EP compendia is required.
Ability to communicate effectively with coworkers and internal or external clients is required.
Ability to learn new tasks quickly and move easily between tasks is required.
Ability to prioritize and handle multiple tasks simultaneously is required.
Ability to use a personal computer and learn necessary programs is required.
Organizational ability and good judgment are required.
A science background or education and/or laboratory experience is required.
Strong math skills and logical thinking and reasoning ability are required.

Responsibilities

Review scientific laboratory data, including standard preparation, calibrations, methodology, quality control, sample data, compound evaluation, and other subjective review based on testing performed.
Perform complex calculations to verify results.
Verify data quality and determine whether data is compliant and defensible based on industry regulations and methodology.
Serve as a technical advisor to analysts regarding quality assurance and quality control of data, as needed.
Diagnose problems, solve simple problems, and suggest solutions to complete problems in the professional area.
Keep current with developments and trends in the professional area by reading and understanding internal procedures, attending or providing training sessions, writing or revising standard operating procedures as required, and assisting Group Leaders or Principal Specialists in training employees.
Use Microsoft Windows applications including Excel, Word, Access, and Outlook; create complex Excel worksheets and formulas.
Communicate findings to internal clients and notify them of necessary rework or compliance and regulatory concerns.
Conduct activities safely and efficiently and apply GMP/GLP requirements in areas of responsibility, as appropriate.
Read and understand analytical procedures.
Demonstrate and promote the company vision.
Maintain regular attendance and punctuality.
Perform other duties as assigned.

Desired Qualifications

Knowledge of laboratory software applications such as LIMS and Electronic Notebook is preferred.
Self-motivation and excellent quality of work and attention to detail are preferred.
Coaching or mentoring peers is preferred.

Job Description

Position Summary:
Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations

Essential Duties and Responsibilities:

Exercise discretion and independent judgment with respect to matters of significance directly related to the management or general business operations through the data review process
Perform review of scientific data, including, but not limited to standard preparation, calibrations, methodology, QC, sample data, compound evaluation and other subjective review based on testing performed; perform complex calculations to verify results
Verify the data is of sound quality and determine if data is compliant and defendable based on industry regulations and methodology
May serve as technical advisor for analysts with regard to QA/QC of data
Diagnose problems; solve simple problems, and suggest solution to complete problems in professional area
Keep oneself and peers abreast of current developments and trends in professional area by reading and understanding internal procedures, attending/providing training sessions, by writing/revising SOPs (as required), and by assisting Group Leader / Principal Specialists in training new and existing employees
Use MS Windows applications such as Excel, Word, Access, Outlook email; create complex Excel worksheets and formulas
Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns
Conducts all activities in a safe and efficient manner
Attention to details
Works in collaboration
Performs other duties as assigned
Applies GMP/GLP in all areas of responsibility, as appropriate
Demonstrate and promote the company vision
Regular attendance and punctuality
Read and understand analytical procedures

Qualifications

Education/Experience (BMQ:

Master’s degree in a science-related field with 15-17 years of experience in Bio/Pharmaceutical drug product/substance testing with knowledge of regulatory requirements.

Theoretical / Practical experience with analytical techniques such as Ligand binding assays, ELISA, Gel electrophoresis, Proteomics, Flow Cytometry, TEM, PCR, cell culture and cell-based assays (such as reporter gene, cell signaling, and cell proliferation). etc. Knowledge of USP/EP compendia, and laboratory software applications such as LIMS, Electronic Notebook is preferred.

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

About the Company

Eurofins

Global lab testing and analytics network

Eurofins provides global laboratory testing and analytical services to verify the safety, authenticity, and quality of products across food, water, medicine, and the environment. It operates a network of more than 900 laboratories in over 60 countries, offering access to more than 200,000 analytical methods. Its product work involves running specialized tests—using chemistry, biology, and other scientific techniques—to confirm origin, composition, and compliance of samples, such as detecting wine fraud or contaminant presence. The company differentiates itself through its massive, distributed lab network and broad portfolio, enabling standardized testing at scale and fast turnaround across many industries, rather than relying on a single specialty or location. Its goal is to protect public health and safety by delivering accurate, comprehensive testing data and helping clients meet regulatory and quality requirements.

Company size: 10,001+
Company stage: IPO
Headquarters: Luxembourg
Founded: 1987

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