Summary:Perform, review and manage assay development, characterization, optimization, transfer, validation and investigation for QC chemistry or QC Biochemistry group. Provide technical support, guidance and supervision for release, stability, and in-process testing and assay development.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Perform, review and manage assay development/validation for QC Chemistry or QC Biochemistry group.
• Review new test procedures and assays.
• May evaluate and bring in new methodologies/techniques when needed.
• Facilitate assay transfer from R&D and to business partners.
• Organize analytical assay transfer internally and externally.
• Participate in technical troubleshooting and problem investigation.
• Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance.
• Participate in training programs for analysts.
• Performs personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations.
• Monitors day-to-day method performance in QC lab and identifies appropriate subject matter expert to help any method related issues.
Education and Experience:
Requires BS/BA or AAS in Life Sciences or related field plus 7 years’ of experience working in a GMP lab including 2+ years of management experience, or:
•MS plus 4 years GMP experience including 2+ years management experience, or:
•Ph.D. with 2 years of GMP experience including 1+ years of management experience.