
Forward-thinking Senior Manager adept at managing teams of 80 employees with 4 direct reports to accomplish challenging objectives. Imparts clear vision to guide cohesive, high-performing teams. Encouraging manager and analytical problem-solver with talents for team building, leading and motivating, as well as excellent relationship-building skills. Proficient in using independent decision-making skills and sound judgment to positively impact company success. Dedicated to applying training, monitoring and morale-building abilities to enhance employee engagement and boost performance. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
· Management of Process Analytics group to generate high-quality, robust, and reliable analytical data to accelerate the development activities of the Tech Ops department by supporting in-process, DS & DP sample testing for product & process characterization.· Ensure members of the process analytics group are suitably trained to independently perform complex data analysis and keep detailed electronic notebook records.· Support the Analytical Development team in the troubleshooting and implementation of new technologies and assays.· Participate in and oversee method development and qualification activities for various analytical methods.· Preparation, qualification, and management of critical reagents for lifecycle management (LCM) of various assays for consistently reproducible data.· Managing laboratory infrastructure (Analytical Equipment, Freezers, etc.) for the optimal performance of the Process Analytics team.· Lead external interactions as SME with CROs / CMOs in matters of Tech Transfer, assay establishment, optimization, troubleshooting, and qualification.· Lead method transfer and qualification activities from non-GMP to GMP labs and associated activities.· Authoring, reviewing, and approving technical documents (e.g., SOPs, protocols, reports, CoA, CoT, memorandums, etc.) that support IND/CTA submissions.· Participate in Quality Event Risk Assessment as a functional SME, and assist in CAPA and other related activities.· Organizing and communicating data to key stakeholders.· Presenting data in cross-functional team meetings and monthly metrics with sample TAT etc. for senior leaders.· Improved the throughput & turnaround times for sample testing year over year (year-1, 80%, Year-2, 40%) by being a key player in the progression of program deliverables by aiding in the generation of robust & reliable data.
Analytical Development
Tech Transfer
Method Qualification/validation
Life Cycle Management (LCM)
ICH Q14, ICH Q2R2, ICH Q12
GMP Process/Documentation
SOP Authoring, Review & Approval
Team Management
Cross-Functional Communication
Operational excellence
Startegic Thinking
A disciplined Bioanalytical Scientist with 9 years of experience, strong analytical skills and expertise working with Glycan Mapping (Dionex),HPLC-SEC, HPLC-RP (Agilent, Water's), UPLC (Water's), CE-SDS (PA 800 plus, LabChip GXII, LabChip Touch), Octet for Capsid titer(QK 384, Red 384, HTX, RED96e), QPCR ( Kingfisher Flex, LightCycler 480,Applied Biosystems™ 7500), ddPCR (Bio-Rad) dPCR (Qiacuity), CIEF (Maurice), TECAN Fluent, GC-MS, UV-Visible, FT-IR, column chromatography, ELISA and wet chemistry analysis. Expertise in inline monitoring of critical quality attributes (CQA's) and development of Impurity quantification assays for various therapeutic modalities including Cell & Gene Therapy products, Antibodies, Fusion Proteins and Enzymes. Experience with authoring relevant analytical sections for IND and BLA filing. Good knowledge of GMP, ICH guidelines & FDA regulations.