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TALENT Software Services

Research Associate I

TALENT Software Services, South San Francisco, California, us, 94083

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Interview Format Virtual (30 minutes) - 4 rounds

Working Model On-site 5 days a week

Shift 8 hours

Research Associate/SRA Job Description for the Cleaning, Compendial, and Materials Group Provides analytical support for cleaning verification activities and the testing of materials in support of R&D activities and GMP manufacture of Drug Substance and Drug Product.

Analytical Techniques

HPLC

HPLC-MS

FTIR

KF

Conductivity

ICP

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 with the qualified method.

Perform analysis on cleaning verification samples to determine drug and detergent residues.

Communicate analysis results to supervisor and 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. Familiarization of analytical instruments, making buffers, hands on experience with pH meter, chromatography (HPLC and GC), and FTIR. Detail-oriented and have good problem solving, written and oral communication skills.

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