Posted:1 month ago|
Platform:
Work from Office
Full Time
Perform routine and advanced analytical testing of small molecules, peptides, and biologics according to SOPs and cGMP standards.
Participate in method development, optimization, and validation for QC assays.
Plan, design and conduct pharmacokinetic studies.
Analyze and interpret data, prepare accurate reports, and maintain proper documentation.
Troubleshoot analytical issues and implement corrective/preventive actions.
Ensure compliance with internal quality standards and regulatory guidelines.
Support cross-functional teams including formulation, process development, and production.
Proven expertise in handling and analyzing small molecules and large molecules (peptides and biologics).
Strong knowledge of analytical techniques including HPLC, LC-MS, UV, FTIR, drug release testing, dissolution testing, peptide and protein characterization methods.
Hands on experience with Openlab cds workstation (preferable), Empower/Lab solutions.
Familiarity with cGMP and regulatory compliance in QC operations.
Experience in analytical and bioanalytical method development, validation, and troubleshooting is highly desirable.
Experience with handling of serum and plasma to conduct pharmacokinetic studies.
Niedlfree Technologies
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