Prashanth Kumar Kumar V, Ph.D Email & Phone Number

India

Responsible for overseeing the Quality Operations of Mylan/Partnered sites for various Biological Drug substance/ Drug Products and combination products. I am providing the strategic and technical leadership, supporting the sustainable quality/compliance, ensuring all aspects of the operational business comply with cGMP, legal, regulatory requirements. I am the key stake holder in supporting the regulatory, quality, compliance as well as to support the successful manufacturing operations to release the materials/products to meet the business and patients need. I am also responsible to manage the budget, provide strategic/optimization plan for the business, lead, and support the site's operations.Major achievements and participations during Employment:➢ Streamlined and established the Quality Management Systems and overall escalation, communication channels, governance, and compliance road maps.➢ Evolved several joint discussion platforms and review boards including the strengthening of the investigation, root cause analysis and CAPA management.➢ Training, developing the skills, strengthening the team, and leading them with strategic initiatives and directions.➢ Played a key role in overall continuous quality improvement projects within the network, that includes quality metrics, KPI, driving open communication and cultural transformation initiatives.➢ Providing strategic and technical leadership for the partner site in all quality, cGMP compliance related matters and ensure that all aspects of the operational business comply with cGMP, legal and regulatory requirements.Skills: Strategy, Quality Operations, Quality Systems, Compliance, Inspection Management, Quality Control, Product distribution, Affiliate and Partnership management, continuous improvement, Talent development.

India

Joined Mylan Laboratories, Bangalore as Senior Director with reporting to Global Head of Injectables. I was the key stake holder in supporting the remediation/quality/compliance of the testing as well as to support the successful manufacturing operations to release the materials/products to meet the business and patients need.Major achievements and participations during Employment:➢ Championed quality mindset/awareness across the laboratory network, partnering closely with commercial, R&D and manufacturing operations across five different sites.➢ Built capabilities to support growth and restored operational performance, led the digitization journey, introducing e-Quality and lab systems.➢ Supported the site operations and growth in the context of capability and capacity expansion, cultural transformation, and open communication initiatives.➢ Established a Central laboratory function with state-of-the-art instrumentation exceeding Rs.80 million to enhance the testing capabilities, self-sustain and to support the business needs.➢ Played a key role in overall quality optimization projects within the network, that includes, visual boards, scheduling, STRT, laboratory management, KPI.Skills: International Mindset, Interpersonal Skills, Decision Making, Cross-functional Collaboration, Change management, Business and Scientific acumen, Drug development, Enterprise leadership, Entrepreneurial.

India

Joined Hospira (acquired by Pfizer), IKKT site as General manager- Remediation role with reporting to Global Quality Head and took over the Chemical Quality Function.Major achievements and participations during Employment:➢ Fostered a culture of ownership and transparency, empowering and coaching teams on problem solving, risk management, continuous improvement. Developed internal communication events and routine to foster alignment and sense of purpose. Implemented a recognition system.➢ Played a key role in overall laboratory optimization projects that includes implementation of 5s, visual management, scheduling management, laboratory KPI, investigations and root cause analysis, driving open communication and cultural transformation initiatives, lean systems leading to site's quality remediation.➢ Played a key role in the implementation of LIMS (Phase I), SDMS, Global stability management, designing of the CQ laboratory infrastructure as well as expansion with a strategic vision to fulfill the increased customer demand for the enhanced capabilities.Skills: International Mindset, Interpersonal Skills, Decision Making, Cross-functional Collaboration, Change management, Business and Scientific acumen, Drug development, Enterprise leadership, Entrepreneurial.

United States

Provided leadership within the quality organization to advance the company mission and objective to promote revenue, profitability, growth, and customer service/satisfaction. Was heading the Quality Control function supporting the business.Skills: Drug Product Development, Quality Control, Regulatory Audits, Entrepreneurial, Change management, Technology Transfer, Process Validation, Continuous improvement

Doctor Of Philosophy - Phd, Pharmaceutical Sciences

Master Of Pharmacy, Pharmacy

B.Pharm, Pharmacy