The Quality Control Associate Scientist is responsible for routine performance of ELISA-based and cell-based potency assays for release and stability of commercial drug substance and drug product. This position includes responsibility for support of analytical method validation and technical transfer, including the preparation of validation protocols and reports.
ESSENTIAL JOB FUNCTIONS:
- Performs routine and non-routine cGMP laboratory testing support; provides subject matter expertise in cell culture and receptor binding assays on drug product and drug substance.
- Records data in a GMP compliant manner; performs peer review of test results; accountable for maintenance and documenting the performance of cell cultures
- Proactively identifies and reports trends or suspect results, supports laboratory investigations and documents laboratory events; drives to determine root cause and Identify CAPA activities.
- Effectively participates validation and technical transfer of analytical methods in compliance with FDA and ICH guidelines. Authors, reviews and approves analytical methods, validation protocols and technical reports.
- Schedules and/or performs preventative maintenance and/or calibration activities; coordinates with external vendors for instrument installation, calibration and maintenance; maintains and appropriately documents use of equipment within the QC laboratory and maintains the lab in a state of inspection readiness.
- Actively seeks ways to improve QC compliance and efficiency; supports QC continuous improvement initiatives.
- Maintains required analytical qualification, documents all training and maintains training records. Trains laboratory staff as assigned and develops training materials as needed
- Prepares technical data for presentation to management.
CORE COMPETENCIES (KNOWLEDGE, SKILLS, AND ABILITIES):
- Familiarity and proficiency with cell biology, biochemical and molecular biology methods and techniques.
- Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
- Must be able to work in a team environment and perform job responsibilities under minimal supervision.
- Proficiency with laboratory software applications.
- Fluency in Windows and Microsoft Office.
EDUCATION/ MINIMUM REQUIREMENTS NECESSARY:
- Master’s degree and 2 years industry experience OR Bachelor’s degree and 4 years GMP lab experience in a Biopharmaceutical and/or Biotechnology environment; or equivalent combination of education and experience.
- Prior cGMP training and experience working in a cGMP/GLP environment required.
- Experience with statistical analysis and ability to prepare analytical reports which include evaluation of trends.
- Experience with industry standards for receipt and testing of product samples, ability to provide guidance and technical support to the testing lab.
- Experience with development, transfer and implementation of analytical method validation based on FDA and ICH guidelines.
– provided by Dice
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