Senior Specialist Data Review - Biologics (Large molecules)

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing.

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

Education/Experience (BMQ:

Master’s degree in a science-related field with 6-10 years of experience in Bio/Pharmaceutical Chemistry 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.

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