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Associate Principal Researcher-Large Molecule Bioanalysis

Date: Jan 8, 2019

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

Responsible for research and development in collaboration with others on large molecule bioanalytical projects. Makes detailed observations, analyzes data, and interprets results independent of supervision. Prepares technical reports, summaries, protocols, and quantitative analyses independent of supervision. Maintains familiarity with current scientific literature and contributes to the process of a project within his/her scientific discipline, as well as investigating, creating, and developing primary ligand binding assay methods and technologies for project advancement. May also be responsible for acting as a main investigator in conducting experiments. May also be asked to participate in scientific conferences and contribute to scientific journals

  • Ensures the implementation of Standard Operating Procedures relating to the Specialty Bioanalytics laboratory and compliance with the requirements of Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and/or Good Manufacturing Practice (GMP) as applicable.
  • Ensures that test methods (mostly ligand binding assay based) comply with current regulatory guidelines as relevant.
  • Ensures that correct, reliable and accurate results are reported and archived.
  • Where deviations occur, ensures that they are fully documented and investigated, reported to Manager and Quality Assurance in a timely manner, as well as suggesting corrective actions and/or  preventive actions for future.
  • Responsible for training and qualification of the laboratory junior team.
    Approves qualifications of the junior personnel after training.
  • Ensures operation of equipment and systems in the laboratory is performed according to approved Standard Operating Procedures (SOP).
  • Where there is equipment malfunction, ensures that maintenance and supervisor is informed, the equipment is marked unusable and segregating if possible, and there is follow up on equipment restoration by maintenance department
  • Prepares and updates method SOPs and Forms.
  • Reviews and compiles large molecule bioanalytical method validation and sample analysis results and prepares data table for reports.
  • Responsible for reviewing Validation Plans, Validation reports, Study Phase reports for accuracy against raw data.
  • Responsible as contributing author for Validation Plans, Validation reports, and Study Phase reports.
  • Responsible for the Development of test methods according to pre-approved strategy plan.
  • Responsible for the validation of test methods according to pre-approved validation plans and acceptance criteria and in accordance with relevant method SOPs and most recent regulatory guidelines.
  • Responsible for all sample handling and performs sample analysis from pre-clinical or clinical studies in accordance with the approved method SOPs, reviews the raw data for accuracy and signs the data package prior to the transfer of the results for reports.

Qualifications

B.Sc. or M.Sc.in Biology or related science with thorough understanding of the ligand-binding assays

Minimum of seven years working experience in bioanalytical laboratory using various technology platforms, e.g. ELISA, MSD, Simoa, Singulex

Basic knowledge in regulatory guidelines related to bioanalysis issues

Function

Research & Development

Sub Function

Biological Research

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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