Position overview: A biologist with at least 1 year of experience in cell culture/cell based assay experience.
Execute and perform testing as per methods, following the company’s Standard Operating Procedures, Deviations and Change Control programs and cGMP guidelines as required by client submissions.
Duties here include preparation for testing by using good time management skills for each assigned task, such as confirming availability of resources (standards, equipment, etc.) and adequacy of testing documentation, proper application of test procedures, proper technique for data capture and recording, and preparation of the final report of analysis.
Ability to execute method verifications, validations, transfers based on signed protocols with supervision.
Perform routine and more complex analysis/testing of pharmaceutical and biopharmaceutical finished products and raw materials.
Record data in timely manner.
Strictly follows the latest approved version of methods, SOPs, QA manuals unless authorized by Department Manager and/or Group/Scientific Leader in writing.
Record findings in standardized format, keeping all records and analyst note book in good order.
Education: B.S. Biochemistry, Chemistry or equivalent.
Must have experience in cell based assays/cultures.
Must have HPLC experience with Biologics (protein).
Experience: Min 1 year with demonstrated ability to complete more complex role/duties.
Works well under pressure.
Demonstrated basic understanding of protein biochemistry, cell biology, molecular biology, and/or biophysics.
Technical competency in two or more of the following;
Mammalian Cell Culture and Aseptic technique
pH, Appearance, Osmolality, Spectrophotometry, Conductivity and others.