Research Associate I
1 DNA Way Mailstop 258A South San Francisco, CA 94080 US
Job Description
This position provides analytical support for cleaning verification activities and the testing of materials in support of R&D activities and GMP manufacture of small molecule Drug Substance and Drug Product.
Job Description:
This position provides analytical support for cleaning verification activities and the testing of materials in support of R&D activities and GMP manufacture of small molecule Drug Substance and Drug Product.
Analytical Techniques
- HPLC
- HPLC-MS
- FTIR
- KF
- Conductivity
- ICP
- ICP-MS
- IC
- GC
- UV
- pH
- Wet Chemistry (USP)
Analytical Duties
- Developing and qualifying (validating) analytical methods capable of detecting low levels of residues on manufacturing equipment.
- Perform swab/rinse sampling on manufacturing equipment in accordance to the qualified method.
- Perform analysis on cleaning verification samples to determine drug and detergent residues.
- Communicate analysis results to his/her supervisor and to the appropriate teams.
- Support analysis of raw materials, excipients, packaging components, starting materials, and packaged clinical supplies using various analytical techniques.
- Residual Solvents testing by GC.
- Routine Water Analysis by KF.
- Compile new specifications for raw materials, excipients, and packaging components.
- Assist in the testing of drug substance and drug products as needed.
Requirements
BS/BA in a relevant scientific discipline. Candidates must have familiarization of analytical instruments, making buffers, hands on experience with pH meter, chromatography (HPLC and GC), and FTIR. Candidates should be detail-oriented and have good problem solving, written and oral communication skills.
Pay Rate Range: $30-40/hr. Salary will be commensurate with experience
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