Ref No.: 18-13654
Location: South San Francisco, California
The shift for this position is Thursday-Sunday, day shift (4 days, 10 hours/day, 0630-1700)
You will perform biochemical and analytical lot testing of raw materials, commercial and clinical fermentation, purification, and final product samples to meet standard lead times.
Review data and assess against established acceptance criteria. Order lab supplies and maintain inventory.
Identify discrepancies, participate in quality investigations and CAPA initiatives as needed.
Prepare and maintain standards, controls, stocks, and cultures per established protocols.
Support the maintenance and compliance of operational areas. Assure strict adherence to cGMPs throughout operation.
Ensure training qualifications are up to date. Identify and support resolution of technical problems.
Perform SWAT and routine maintenance duties to ensure inspection ready state.
Additionally participate in assay, facility, equipment and process validation. Perform equipment qualification and maintenance activities.
Actively participate in group and project teamwork; project and process improvements.
Draft protocols and reports under supervision.
Work with internal and external groups to develop methods for clinical products for in process and final products testing.

BS degree in Microbiology, Chemistry, Biology or related field and a minimum of 2 years relevant experience in the bio/pharmaceutical industry.
Experience in the conduction of chemistry assays such as TOC, UV Spectrometry, pH and HPLC is a plus.
Sound knowledge of cGMPs or equivalent regulations.
Experience using basic computer software (Word, Excel, and PowerPoint). Working knowledge of SAP, Labware LIMS and Livelink a plus.
Ability to communicate clearly and professionally in writing and verbally. Basic knowledge of scientific theories, principles and techniques used in biological or analytical test procedures.
Ability to exercise sound judgment, reasoning and problem solving.
Ability to work off-shift, weekends and holidays as needed.
Must be physically able to perform the following tasks: Work in a laboratory environment including biosafety cabinets. Able to lift up to 25lbs. Sit, stand and move within work space for extended periods.