Lead Scientist, AS&T

Essential Functions

• Oversees and manages the QC activities involved development, transfer, qualification, verification, and validation of test methods.
• Works with internal and external clients to draft/review/approve protocols and reports, and to create timelines and schedule resources and activities.
• Provides technical expertise for method development/optimization, verification, qualification and validation. Analyzes and interprets data, investigates analytical problems, and works with clients to develop approaches to rectify those problems as needed.
• Ensures QC equipment compliance to USP and 21CFR211 part 11. Performs site Administrator role for QC equipment and LIMS.
• Interacts with contract, corporate, and governmental agency representatives and auditors.
• Regularly presents to and interacts with senior management to set and modify goals, budget and operations related to the functional area.
• Create and update schedules and presentations as needed; participate in departmental senior staff meetings and decisions.
• Review current laboratory practice to identify alternative strategies or cost saving measures for laboratory improvement.
• Provides scientific review and approval of protocols, reports, study design and standard operating procedures.
• Performs managerial duties, as assigned, in support of QC operations such as resource management and failure investigation review.
• Investigate, troubleshoot, and resolve test method and QC equipment deviations and CAPAs. Provide SME support as needed.

Minimum Education, Experience, Skills

• BS degree with at least 10 years of relevant experience or MS degree with a minimum of 8 years of relevant experience.
• Possess skills and knowledge of general immunological, bioanalytical and chemical test methods such as ELISA, qPCR, IEF, Viral and Cell-based assays, SDS-PAGE, Western Blot, DNA sequencing, microbiological methods, Sterility testing, Endotoxin testing, HPLC with multiple modes of detection, CE, and UV and IR spectroscopy.
• At least 5 years prior Management experience required.
• Advanced knowledge of USP/EP, cGMPs, 21CFR part 11, and data integrity.
• Experience in executing phase appropriate method qualifications and validations.
• Experience in assay method validation, equipment validation, and analytical investigation for biotherapeutic and vaccine products.
• Ability to apply statistical analysis to QC monitoring and trending.