As a Fellow of the prestigious Royal Society of Chemistry, my colleagues and I play a crucial role in advancing the chemical sciences. We actively promote the value of chemical sciences and provide mentorship to peers, students, and junior professionals within the community. We publish our research and present findings at industry events to enhance the visibility of our work. Additionally, we help shape scientific policies within the Royal Society of Chemistry and advocate for the chemical sciences, supporting initiatives that aim to advance the field globally.

As a Senior Partner in my advisory firm, my primary responsibility is to lead the team, manage client relationships, and drive the firm's success in the highly competitive and dynamic life sciences industry.Some of my key leadership responsibilities include:Strategic Planning: Formulating and executing strategic plans to drive business growth and achieve client objectives.Client Relationship Management: I serve as key clients' primary point of contact, ensuring solid, long-term relationships and high client satisfaction.Business Development: Identifying and pursuing new business opportunities, including expanding services to existing clients and acquiring new clients.Project Oversight: Overseeing multiple projects simultaneously, ensuring they are completed on time, within budget, and to the highest quality standards.Resource Allocation: Allocating resources effectively across projects, ensuring optimal team performance and project outcomes.Performance Management: Conducting performance reviews, providing constructive feedback, and supporting the professional growth of team members.Industry Representation: Representing the firm at industry conferences, seminars, and through publications to enhance the firm's reputation and visibility.Client Presentations: Preparing and delivering compelling presentations showcasing the firm's capabilities and project outcomes.Process Improvement: Identifying and implementing process improvements to enhance the efficiency and effectiveness of service delivery.Client Feedback: Gathering and acting on feedback to continuously improve service delivery and client satisfaction.

In this progressive role, I led complex investigations, ensured robust compliance, managed inspections, and fostered effective communication with the USFDA and internal stakeholders. My key responsibilities included surveillance and regulatory communications, directly contributing to monitoring product safety signals and ensuring the safety and efficacy of healthcare products globally. Leading a strong team of 25 global members, I was responsible for managing and overseeing all critical quality escalations, health authority inspections, and executing the global investigations review program across the Viatris network

Invited by Assistant Secretary for Critical Infrastructure Protection Todd Keil in 2011 to join the DHS Critical Infrastructure Committee (CIC), my core responsibilities included providing and sharing methodologies with other federal agencies, DHS members, and CSAT teams for conducting Security Vulnerability Assessments (SVAs) and preparing Site Security Plans (SSPs). I actively participated in annual DHS seminars and workshops on chemical and biological security, and maintained constant interaction with local, regional, and directorate leadership of DHS to address and share critical security issues.I also focused on educating and encouraging organizations handling chemical and biological reagents to participate in the CSAT program at my workplaces. As a member of the National Infrastructure Coordinating Center (NICC), my critical functions at my work places included:Creating situational awareness by collecting, maintaining, and sharing information about threats to infrastructure.Integrating and disseminating information throughout the critical infrastructure partnership network.Evaluating infrastructure data for accuracy, importance, and implications.Providing recommendations to critical infrastructure partners and with local DHS leadership.Supporting decision-making for actions required 24–72 hours before and after an incident or event.

Responsible for Compliance and Quality Operations of OSD products across multiple sites.

Responsible for the Laboratory quality operations across all Baxter global manufacturing networkOverall leadership responsibilities for the Quality Organization of Baxter Pharmaceuticals GBU.Accountable for ensuring ‘Harmonized’ quality practices across Baxter Global manufacturing networkResponsible for identifying and executing growth strategies for the Pharmaceuticals business w.r.t quality operations (M&A activities, Compliance risk identification, remediation and Integration activities)Global responsibility for preparing pharmaceutical manufacturing sites for all time inspection readiness, hosting audits, leading FDA Inspection responses and accountable for ensuring on time completion of commitments and effectiveness verification of commitments.Accountable for implementing the 'Quality Culture’, an organizational drive that is fully aligned with the Baxter mission , ‘Saving and sustaining lives’.

Global responsibility for Quality Operations across all Mylan manufacturing locations (Product quality (mfg and release), product safety, HA remediation and continuous Improvements)Global responsibility for market actions, complaints handling, investigations (internal and external) and all pertinent US FDA and all other HA communications.Accountable for ensuring Mylan drive towards establishing 'One Global Quality Standard' across all global manufacturing locations.Accountable for Global operational integration activities for Mylan's new acquisitions (Establishing charters and governance and driving the activities to on time closure).Global responsibility for preparing sites for HA inspection readiness, hosting audits, leading FDA Inspection responses and accountable for ensuring on time completion of commitments and effectiveness verification of commitments.Accountable for implementing the 'Quality Culture' , a Mylan corporate drive that developed and harmonized behavioral based culture and all time quality and compliance mindset across the organization.

Key member of Mylan corporate quality management team, responsible for providing systematic overall support to the quality operations and compliance activities of Mylan's injectable manufacturing sites around the globe, particularly in Ireland, India, Poland and Brazil.Responsible for ensuring successful implementation of Industry best practices, Applicable US, International quality and compliance standards and building Mylan's 'One Global Quality' Standard across all other Mylan family of companies.

Provide strategic and tactical planning relative to quality, regulatory, compliance and collaborate with management team at all company levels on priorities.Ensures that quality management systems, GMP Compliance systems and regulatory systems across the global sites are aligned, harmonized and maintained flawlessly at all times.Primary responsibility for designing and implementing risk based metrics program across all global sites.Manage the implementation and ongoing sustainability of pharmaceutical, medical device GMPs and IVDD quality controls.Provides leadership in harmonizing, developing and implementing company policies, procedures, KPIs and other critical quality measures.Serve as representative to government agencies concerning the quality of company products and reliability of processes.Partner with critical cross functional teams to drive process improvements, compliance awareness and reduce / mitigate risk exposure.Lead, coach and mentor staff globally.Prepare budgets for operating expenses and capital investment as it pertains to quality and ensure cost-efficient quality processes for QA and QCAssess Global Regulatory and Compliance trends and develop effective internal strategies to address the trends.Develop, Implement and Monitor Risk based strategy and problem solving methodology cross all key functions in the organization.Continuously drives best practices and external benchmarking and develop strong relationships with all internal and external stakeholders regarding quality issues.Manage effective global audit process and develop robust quality system plans to drive corrective and preventative actions globally.Ensures a collaborative and productive relationship between quality and manufacturing staff.Formulate and drive NPD stage gate process effectively for NPIs and Improve PVI.Training technical teams and suppliers globally on changing regulations and help them update their systems.

In addition to global quality responsibility for 100,000 plus product line among 4 major brands, I am also responsible for Global Engineering (Process and Packaging) and facilities management that support necessary engineering, production/re-processing and various quality across all Global sites (North America, UK, Europe, India, China, Australia) for Global Chemicals Business. Some of my critical responsibilities :Designing and driving Good Manufacturing and engineering Practices globally Professionalize Process and Facilities engineering teams via rigorous training on advanced statistical engineering tools usage and bringing an approach of data driven, analytical management methodologies to day to day operations.Implement robust PM programs globally for business sustainability and progressResponsible for designing and implementing 'Global Supplier Qualification Program' in compliance with Thermo Fisher Corporate guidelines and to effectively manage 1500 plus supplier base in US, EU, China, Australia, UK and India.Acting as a central control point of the Global Chemicals business for Product quality, Engineering, Process Controls, Risk management and Product liability issues.Responsible for identifying Product quality issues, implementing a timely corrective action process plan to support sales and customer service teams in a complex organization matrixResponsible for designing and implementing risk based facility management programs globally.

Responsible for leading the Global Quality Function through supervisory management of global site quality teams and by establishing organizational structures & quality policies that are uniformly deployed across Thermo Fisher Global Chemicals Business.Responsible for over all quality (Product Quality, Process Quality, OEM and Contract manufacturer's quality) of 100,000 plus product lines for Global Chemicals (Major Brands : Fisher Chemicals, Fisher Bioreagents, Acros Organics, Maybridge and Regional brands Qualigens fine chemicals, AJAX, Fronine)Responsible for managing existing ISO quality accrediations across the globe and accountable for building cGMP quality program across global manufacturing facilities.Accountable for designing,developing and managing various metrics to measure organization's quality objectives performance.Responsible for identifying Product quality issues, implementing a timely corrective action process plan to support sales and customer service teams in a complex organization matrixAccountable for effective development and implementation of methods that continuously improve the product quality while reducing the cost to achieve the desired goals.Responsible for designing and implementing effective lean management methods for the relentless pursuit of manufacturing process controls and Warranty claims reduction.Responsible for maintaining effective Supplier quality program across all global sites with multiple hundreds of vendorsResponsible for identifying opportunities and develop business cases for new products with other busienss divisions among Thermo Fisher Scientific.

CRO for USAMRDC https://www.banyanbio.com/Responsible for long term goals of quality efforts in support of company's first TBI Point of care diagnostic deviceResponsible for managing the entire quality program of the company (Product Development, Assay Development, GLP Analytical Lab, Clinical Research,Contract manufacturing and development).Ensure internal processes and metrics are aligned to create highest product quality and complaint with the FDA GLP, GMP Quality systems.Responsible for providing leadership and strategic direction to the quality function and ensuring proper interface of quality function to manufacturing, Core research, Product Development, Assay development and Marketing.Responsible for building strong relationships with major corporate vendors, Research & Process development partners, US Federal agencies,University Investigators and effectively relating the quality function to the entire company.Formulates and recommends quality assurance (QA) policies and programs.Develops, and maintains departmental budget for quality assurance and quality control, including defining materials, equipment and personnel needs.Directs QC staff and daily operations to include: release and stability testing, in-process testing, QC inspections and audits, QC documentation, equipment maintenance and calibration and QC laboratory design and maintenance.Manages GMP material control program to include: QC material management (labeling and storage), QC materials inventory and materials lot control.Oversees component and finished product stability program, transfer of validated methods to routine use, and participation of QC staff in support of validation of methods and equipment. Establishes and directs QC control programs and GMP training programs.Reviews and approves reports and other documentation prepared by QA and QC for regulatory submissions/inspections.Assures finished products conform to US and International regulatory standards.

CRO for USAMRDC https://www.banyanbio.com/Responsible for short and long term goals of quality control (QC) laboratory efforts in support of IND, PMA and other milestones. Responsible for managing the entire quality program of the company (Product Development, Assay Development, GLP Analytical Lab, Clinical Research). Ensure internal processes and metrics are aligned to create highest product quality and complaint with the regulatory systems.Responsible for providing leadership and strategic direction to the quality function and ensuring proper interface of quality function to manufacturing, Research and Development, and marketing.Responsible for building strong relationships with major corporate vendors, Research & Process development partners and effectively relating the quality function to the entire company.Formulates and recommends quality assurance (QA) policies and programs. Develops departmental budget for quality assurance and quality control, including defining materials, equipment and personnel needs. Directs QC staff and daily operations to include: release and stability testing, in-process testing, QC inspections and audits, QC documentation, equipment maintenance and calibration and QC laboratory design and maintenance. Manages GMP material control program to include: QC materials management including labeling and storage, QC materials inventory and use and materials lot control. Oversees component and finished product stability program, transfer of validated methods to routine use, and participation of QC staff in support of validation of methods and equipment. Establishes and directs QC control programs and GMP training programs. Reviews and approves reports and other documentation prepared by QA and QC for regulatory submissions/inspections. Assures finished products conform to government and company standards and satisfies GMP regulations.

CRO for USAMRDC https://www.banyanbio.com/Responsible to ensure all processes, facilities and systems conform to quality standards and governmental regulations Responsible to conduct internal audits to monitor processes, facilities and systems. Responsible to Conduct Process control audits, QC procedure audits and raw material inspections. Reviews and approves operating procedures in Assay Development, Product Development, GLP lab and Quality Control departments. Responsible to ensure that the Equipment Calibration Program complies with the GMPs requirements. Coordinates interdepartmental activities. Develops budgets and monitors expenditures. Responsible to identify, classify and qualify vendors.Responsible for the research, coordination, implementation, and management of Environmental, Health and Safety issues including Chemical and Biological waste disposal, air/water quality,hazardous waste, and land management. Prepared procedures to meet DRMD (US DOD), EPA, DOH(state),DHS permit applications and performed environmental regulatory reviews. responsible to perform periodic inspections of facility operations, participates in reviews of other facilities' environmental activities and participates in environmental audits. Responsible to Develop and maintain documentation to assure compliance with governmental regulations. Responsible for the development and management of programs to meet regulatory requirements, including corrective actions, monitoring and reporting to environmental agencies as and when required.

Responsible for assisting analysts to manage timelines effectively to meet client and internal timelines with resources available. Supervised other analysts and direct project related matters on day to day operation of Product development and Analytical Service department.Worked on problems relating to analytical assays on biotechnology derived products which require data evaluation based on a variety of laboratory techniques. The techniques include, but are not limited to, HPLC, Capillary Electrophoresis, gel electrophoresis, ELISA, and other related methods. Written SOPs, Test Methods and validation protocols and have the knowledge to write and execute new developmental activities.Use of technical proficiency, scientific creativity, independent thought and collaboration with others to solve analytical assay related problems. Implemented industry and government standards regarding safe handling of biohazard materials. Tabulated data, and prepared technical reports for management as well as clients. Analyzed, compiled and reported results to cross-functional teams. Maintained laboratory notebooks and followed GLP and cGMP documentation requirementsTrained analysts on GLP, GMP responsibilities and Good Documentation Practices.

• Conducted QA compliance audits of products and processes.• Implemented safety regulations, encouraged safe working practices, corrected obvious hazards immediately .• Implemented and coordinated compliance with all applicable standards such as ISO 9001,and other applicable customer requirements.• Ensured that all QA department personnel are trained to perform their jobs effectively and manage the QA departmental budget and other administrative functions to insure an efficient operation that is cost effective and well integrated.• Established the overall requirements for QA specifications and standards for materials, processes and finished products for the Product development department.• Reviewed product and process non-conformance and recommend remedial actions including but not limited to modifications of processes, products or QA standards where warranted.• Developed QA plans and other required control procedures to insure Compliance with GxP procedures.• Directly supervised a team of 11 quality chemists and 3 QA team• Designed effective training matrix and approval matrix for procedures and protocols in compliance with WHO GMP• Implemented and coordinated compliance with all applicable clinical research standards (FDA GCP and IRB guidelines)• Trained and Implemented CDER guidelines for handling BA and BE testing samples.• Conducted and monitored blind studies with clinical endpoints• Managed In-house clinical studies (conducted by study sponsor) for Sepsis and Alzheimer’s Biomarkers• Responsible for data integrity and data analysis in support of client’s 510(k) applications and Clinical data submission for the FDA

Performed and Supervised the development, implementation and maintenance of quality control systems and activities. Oversaw development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy, efficacy and reliability of products. Coordinated interdepartmental activities. Developed budgets and monitored expenditures. Providedguidance to employees and supervised the work group. Responsible for hosting all regulatory inspections. Coordinated responses for inspection findings including all follow-ups.

Conducted routine and non-routine analysis of raw materials, in-process and finished formulations under supervision and according to Standard Operating Procedures (SOPs).Compiled data for documentation of test procedures and prepares reports.Calibrated and maintained lab equipment.Reviewed data obtained for compliance to specifications and reported abnormalities.Revised and updated SOPs. Performed special projects on analytical and instrument problem solving.

Supervisory responsible for completion of GMP quality control activities of APISupervisory responsible for managing team that conducts Quality Control testing for process, raw material, stability and release testing that ensures meeting defined timelines for analytical testing and data reviewResponsible for day to day management of both wet chemistry lab and Instrumentation techniques lab (laboratory consisting HPLC/GC, FT-IR, UV-VIS, NMR, IR etc) Responsible for investigating laboratory failures for root cause analysis and assist in the development of appropriate corrective and preventative action follow-up strategies to prevent recurrence of failures.