Sarah Kumar Email & Phone Number

United States

South San Francisco, California, United States

• Directs, coordinates and exercises functional authority over R&D Engineering, Intellectual Property and associated project personnel for planning, organization, control, integration, execution of and completion of R&D engineering projects• Provide vision and leadership for existing and emerging product and application technologies through an understanding of customer and business needs• Work closely with and follow direction from senior management to ensure overall goals, and objectives of the department are being met

• Manage project scope, goals, and deliverables that support business goals as defined by senior management and stakeholders• Communicate project status to senior management and stakeholders• Manages the operational aspects of a scope or project• Ensures that all the documents needed for a project are complete, confidential and properly stored

• Executed validation master plan and validation project plan• Evaluation of equipment and systems, identification of critical feature and defines appropriate test plan, protocols, data records and deliverables• Validated system level / user site requirement testing for automated systems• IQ / OQ / PQ validation protocol generation• Documentation of identified bugs in test track defect tracking system• Ability to think outside the box testing

• Overseen manufacturing and shipping daily operations• Inventory management of RM, WIP and Finished goods• Participate in the evaluation, implementation and validation of ERP and MRP systems• Directs and coordinates activities of test, inspection, quality assurance and assembly• Reviews production and operating reports and resolves operational, manufacturing and maintenance problems to ensure minimum costs and prevent operational delays

• Experienced in Immunohistochemistry and In situ hybridization assays• Creates and executes research work plans as appropriate to meet changing needs and requirements • Prepares design reviews in accordance with design control procedures • Provided technical support for automated stainer and other equipment’s which involves software and hardware integration• Underwent training in GMP, GLP, FDA compliance, Regulatory, Design control in medical device industry

• Experienced in Immunohistochemistry and In situ hybridization assays• Responsible for technical contents for marketing (Mass marketing email, Product promotions, literature’s, Brochures and Marketing materials for distributors)• Instrumental in developing technical contents for product catalogue• Developed Corporate and Sales presentations (Power Point)• Evaluation of the products to prepare manuals and marketing collateral• Competitive analysis of products and product positioning

• Performed variety of duties to support the testing, delivery and distribution of lab results• Exposed and Handled various clinical automated instruments and human samples in a clinical lab • Proficient with computer systems and multiple software programs on various automated systems• Data entry of laboratory results into the lab computer system

• Demonstrations in field for rapid identification kits and explored the market in clinical, food and pharmaceutical industries like Parke Davis, Associated capsules etc.• Maintenance of SOPS for QA/QC of Microbiology lab and Sterilization procedures and implementing IP, BP and USP procedures for testing raw materials and finished products• Capable of running full service microbiology, well rounded microbiological skills and knowledge of maintenance, sterile design, contamination monitoring and control procedures, lab instrumentation and inter personal skills. (QA & QC procedures)• Well rounded training in operation management, Verification and Validation• Gone through in house training in GMP, FDA compliance, Regulatory, Design control in medical device industry• Proficient in patent search and in preparing provisional and full patent application