Maymol Cherian Email & Phone Number

South San Francisco, California, United States

Working with CMOs to ensure 'right at first time' method validation and process validation activities.

Los Angeles, California

 Provided Technical oversight of the validation department. Established process validation strategy based on Life Cycle Approach through risk- based and knowledge-based approach. Developed validation master plan, and relevant SOPs, implemented procedures to establish a regulatory compliant validation program.  Performed QbD and DOE route to determine CPPs, CQAs and CMAs for different process operations and products. Designing acceptance criteria and control strategy. Supported deficiency from regulatory and audit observations. Conducted Statistical evaluation using JMP/ MoDDE software and recommendation for process optimization for process development and technology transfer. Involved in Risk Assessment using the FMEA tool for various processing steps.  Reviewed and recommended analytical method validation activities.  Monitored stability studies of API and Drug Products, providing data evaluation using statistical tools for trend analysis and rate of degradation. Reviewed/ Prepared Manufacturing Batch Records related to validation activities. Investigated deviations and follow up on the recommended actions for validation batches. Implemented Hold Time/Stability Studies and monitoring assay trend and degradation rate. Reviewed of IQ, OQ, and PQ, Cleaning, Method and Laboratory Instrumentation Validation Activities.

Toronto, Canada Area

Coaching team members on supplier driven change evaluation and risk analysis. SME guidance to API related issues Statistical Data Analysis and Continuous improvementChange Management

Toronto, Canada Area

Leading Process Validation group of 12 members, Implementing stage 2 and stage 3 process performance qualification program as per FDA guidance, Execution of detailed statistical analysis for stage 2 and stage 3 PPQ studies.

Brantford

• Development, execution, maintenance of validation activities and validation master plan with regard to Process and Cleaning.• Preparation and review of validation Protocol, Report and Annual Product Reviews for various products.• Risk assessment to changes to Analytical Methods, Process, and Facility with respect to validation program.• Technical Expertise and Assessment to Deviations and CAPA Program, Product Specifications.• Detail-oriented with strong analytical, investigative and technical report-writing skills.• Good knowledge of statistical analysis in validation activities• Preparation for external Audit Program and devising response strategy• Product Complaint & Returned Goods System, Vendor Qualification Program.• Provides technical support in investigation of OOS/OOT investigations, stability/shelf life assessments etc.• Prepares periodic trend reports, makes recommendations and works with cross-functional teams for implementation of appropriate corrective measures/improvements.

- Developed an efficient process by decreasing reaction time 10 times shorter and 99.5 % recovery.-Modified a process to minimize the genotoxic impurity to NMT 0.10%.- Designed and developed a novel method for the estimation of molecular weight from the viscosity measurement for a complex polymer.- Expertise on Design and Optimization of the operating parameters for several projects using Statistical and Computational tools. - Experienced with Safety analysis for the operating parameters using isothermal and adiabatic calorimetry, Powder safety analysis- Involved in developing products with high purity from crystallization techniques, - Experienced with high pressure reactions, Gas-Solid reactions.- Possess comprehensive knowledge about industry safety standards such as WHMIS,OHSA etc.

Upgradation of oilsands using nanosized zeolite materials. Removal of sulphur from Athabasca oil sands using modified zeolite catalysts

Catalyst development for petro chemicals, synthetic zeolite materials for gas separation, oil cracking etc.

- Achieved 10-15 % reduction in sulphur content for Athabasca oil sands during the research work over Zn-Chabasite material for desulphurization of Oil - Development of N2O as an oxidizer instead of O2 for oxidative dehydrogenation of propane. 20 to 30% improvement in propene selectivity was achieved- Synthesized and characterized V/TiO2- SiO2 catalytic materials which has higher surface area and better catalytic properties than V/TiO2- Established Structure-Reactivity correlations for the synthesized materials for catalytic reactions using various spectroscopic and microscopic techniques.- Performed kinetic and modeling studies for various chemical reactions and statistical analysis of the models.

Thesis: Oxidative Dehydrogenation of Propane using Supported Chromia Catalysts Details: - The research work dealt with the identification of an industrially important catalyst (Chromia based catalyst) for selective oxidative dehydrogenation (ODH) of Propane. - It involved different characterization studies such as, XRD, Raman, XPS, UV-Vis, EPR, TPR, TEM of several supported chromium oxide catalysts - It involved comparison of differently loaded and differently supported chromia catalysts for ODH.- It addressed the influence of additives on the structure-reactivity properties of supported chromium oxide catalysts- It suggested a possible mechanism for the ODH reaction and included kinetics and modeling studies of ODH over supported chromia catalysts

Post Doctoral, Chemical Engineering

Activities and Societies: Student CouncilResearch and development on molecular sieves and their industrial applications. Specialized.

Ph.D, Chemical Engineering

Activities and Societies: Co-ordinator of Scripture studies. Member of Evangelical Union of IndiaPost graduation in Chemical Engineering

Bachelor Of Technology (B.Tech.), Chemical Engineering