Mathi S Senapathi

adyq9p@r.postjobfree.com Irvine, CA, 92602 adyq9p@r.postjobfree.com 714-***-****

Director/Sr. Manager of Qa & Qc

Core Proficiencies

•Quality Assurance & Control

•Team Leadership & Building

•Operational Management

•Risk Assessment & Mitigation

•Reporting & Documentation

•Process Improvement

•Relationship Development

•Stakeholder Communication

•Issues & Dispute Resolution

Career Experience

Sr. Manager Quality Control, Center for Bimedicine and Genetics, Duarte, CA 6/2021 to Present

Spearhead end-to-end management of 9 Bio Analyst to test and release final products for public and patients internaly at City of Hope and internationaly (stem cell drug products, viral vaccines, viral vector drug products). Address FDA question for IND in a team environment as a member. Lead and support Principle Investigators in IND application and budget for GMP and Pre IND Engineering run and GMP runs.

Demonstratred expertise in method development in new testing methods, while introducing new analytical instruments.

Conducted complex bio analyses to detect virus, bacteria, mycoplasma, and adventitiouse virus in final products for US GMP release.

Successfully implemented new work rules for maximum productivity.

V.P Operation, Pathogenesys LLC 01/2009 to 5/2021

Ensure the effective management of laboratory operations, including utilizing chemical, physical, or biological factors to conduct experimental research, tests, or demonstrations. Administer and maintain a budget in line with company set standards as well as forecasting revenue. Take the necessary decision to buy and install new equipment.

Organized, archived, and updated Q.A. department files and IRB communications.

Enhanced staff skills and capabilities by arranging and leading staff training session regarding GLP and HIPPA.

Director of Manufacturing, Radient Pharmaceuticals 07/2010 to 12/2011

Held complete responsibility for the manufacturing of RPC's Onko-Sure® in vitro diagnostic (IVD) cancer test kits. Established and oversaw quality systems and compliance programs in relation to GLP and ISO9001, ISO 13485.2003.

Served as the FDA and research compliance audit liaison.

GLP Quality Specialist, Allergan Inc., Drug Safety Evaluation 9/2006 to 4/2008

Developed and maintained expert-level knowledge and understanding of In-vitro in-situ micronucleus studies for genetic mutation screening.

Conducted and steered cytotoxicity study for corneal epithelial aberrations.

Genetic Toxicology Specialist / GLP Quality Specialist, Allergan Inc., Drug Safety Evaluation 6/2005 to 9/2006

Oversaw the development and implementation of quality systems and compliance programs as per GLP and ISO9001, ISO 13485.2003 within Drug Safety Evaluation (DSE). Delivered impeccable guidance and recommendations to management on reporting status and WWQA to improve compliance and quality within the organization. Oversaw all the facets of department activities for ISO 9001, ISO 13485.2003, and GLP compliance World Wide Q. Timely responded to CRO requests for subcontractor Q.A. compliance statements and data. Succeeded in maintaining and auditing training binders for DSE personnel, including the filing of training documents. Ensured the seamless running of processes by arranging and aligning CRO database files (CRO binders' contractor and subcontractor status technical evaluations). Provided pivotal leadership and direction for improving policy and procedures with CROs.

Recognized as a core individual and core FDA and research compliance audit liaison for facility audits and proactively involved in audit and followed up on corrective actions.

Coordinated and steered the training session with an ultimate goal to train and coach DSE scientist in GLPs.

Initiated and completed CRO archive project for disposition of raw data, test articles, and pathology specimens.

Leveraged astute capabilities while managing general equipment use, calibration, and maintenance

Piloted the creation, implementation, and maintenance of SOP system.

Boosted the workflow efficiency by streamlining electronic document control systems containing SOPs, forms, and other relevant information.

V.P Operation, Pathogenesys LLC 7/2003 to 5/2005

Liaised with Pharma and Biotech clients in deciding appropriate test procedures, assay, and reporting methods to meet customers' needs. Validated all ELISA, IHC, and PCR assays as well as culturing tumors and cell lines. Proactively involved in internal and external lab audits. Leveraged technical acumen to maintain all equipment files and services. Ensured the effective management of the scheduled Q.C. performance for all procedures.

Steered the development session for QC/RC records and training employees.

Trained coached employees in GLP, GCP as well as supported in meeting day-to-day needs on several matter.

Designed and complied with SOP also maintained document control and document review process.

Successfully created and maintained I.Q., OQ, and P.O. performance for every piece of equipment in the lab.

Director Quality Control, Meyer Pharmaceutical Irvine, California 11/1997 to 6/2003

Devised strategies to improve and streamline work and personal as required under cGMP, cGLP, and GCP. Collated and archived batch records and patient information and compiled batch records for each batch/product.

Planned, tested, and gathered data to determine the quality of raw material used in the manufacturing process to keep GMP standards' quality compliance.

Conducted research on breast and brain cancer immunology in preclinical animal study clients, including extensive cell culture and ELISA procedure and Flowcytometer assay development, validation, and data collection and maintenance.

Managed and regularly updated database for adverse and non-adverse reaction clinical data.

Utilized analytical expertise in collecting and culturing PBMN cells from donors and qualified patients.

Adhered and applied the FDA guidelines for labeling and transportation.

Education

Mater of Philosophy, University of Madras

Master of Arts, University of Madras

Bachelors of Science, Biology Major and Chemistry, University of Madras, Madras, India

Continuing Education

Expert Resource ISO 13485 Extended Training

Virginia Polytechnic Institute & State University, Risk Management Systems Medical Devices

Los Alamos National Laboratory, Flow Cytometer Annual Class

Coulter Miami FL. Extended Flow Cytometry Training

UC Irvine, Patient Care Program

Cypress College, Registered Nurses Classes

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