Responsibilities:
Perform routine and non-routine release, in-process and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP.
Perform Analytical assays such as HPLC (SEC, IEX, HIC, RP, affinity), ELISA, SDS-PAGE, Western Blot, Water Content, UV, Appearance, and pH.
Independently author and lead quality records such as Deviations, Lab Investigations, CAPA, Change Control including leading thorough and timely investigation and/or implementation activities.
Author and revise SOPs as needed.
Lead and/or support method development, optimization, transfer, qualification, and validation activities of analytical methods.
Support equipment and software qualification and maintenance activities.
Review of laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents.
Provide training to laboratory analysts as needed and guide junior analysts in the lab environment including troubleshooting.
Work on multiple projects to meet departmental and organization goals.
Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.
Skills: Prefered Experience:
3-4 years in a Quality Control laboratory environment (GMP environment) with a commercial setting.
Hands-on experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fisher and HPLC (SEC, IEX, HIC, RP, affinity).
Writing and or authoring deviations, lab investigations, protocols, SOPs, reports, and data trending.
Prior experience working in method validations, method transfers, Raw material and stability testing is a plus.
Must be able to maintain data integrity, and understanding of US and international (e.g. EU, ICH, GXP) regulations.
Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity, solutions oriented and able to problem solve and identify root cause.
Education
BS in Biology, Chemistry or related Sciences.
Required Skills:
- LABORATORY
- HPLC
- ELISA
- WESTERN BLOT
- QUALITY CONTROL
- Additional Skills:
- QC TESTING
- GXP
- QA
- MAINTAIN DATA
- AUDIT
- CHEMISTRY
- CMC
- SOPS
- CGMPS
- DOCUMENTATION
- CGMP
- GMP
- MAINTENANCE
- CORRECTIVE AND PREVENTIVE ACTION
- IEX
- STABILITY TESTING
- ANALYTICAL ASSAYS
- SEC
