Sr. Research Associate

Company Name:
Teva Pharmaceuticals
PLEASE NOTE: Our Rockville site will be relocating to West Chester, PA in the third quarter of 2015. The candidate must be willing to relocate with the company at that time
Performs assay development and validation, and/or pre-clinical and clinical sample testing activities in Global Bioassays and Technology laboratory. Alternatively may perform bioassay development, validation and sample testing for product characterization and/or product release.
Responsible for research and development in collaboration with others on 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 new 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 global Bioassays and Technology (gB&T;) laboratory and compliance with the requirements of Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) as applicable
Ensures that test methods 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 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.
Education :
B.Sc. or M.Sc.in Biology or related science with a minimum of seven years working experience in bioanalytical laboratory and basic knowledge in regulatory guidelines related to bioanalysis issues.
PLEASE NOTE: Our Rockville site will be relocating to West Chester, PA in the third quarter of 2015. The candidate must be willing to relocate with the company at that time
Date: 2014-03-14
Country: US
State: MD
City: Rockville
Postal Code: 20850
Category: Research & Development - Biopharmaceutics

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