Summary
Overview
Work History
Education
Skills
Certification
RESEARCH PUBLICATIONS & CITATION
Timeline
Generic
PRASHANTH KUMAR

PRASHANTH KUMAR

Bangalore

Summary

Currently, I am spearheading CivicaRx’s external manufacturing operations in the region, evolving strategy and aligning CMO/CDMO operation and performance with company’s supply chain, quality, and regulatory requirements. Prior to this I served as the Head of Regional Biologics Quality Operations at Viatris, a dynamic role I’ve held since March 2020 following the merger of Mylan and Upjohn of Pfizer. My journey with Mylan began in July 2016 as the Senior Director of Quality involving remediation, network harmonization, lean quality management, instilling quality culture and improvement of different CMC systems gaining operational excellence. Before my tenure at Viatris, I garnered invaluable experience at Hospira/Pfizer Global Supply, where I undertook multifaceted responsibilities encompassing Quality Control, Quality Assurance operations, compliance oversight, analytical and process development, as well as batch releases. My professional trajectory also includes impactful roles in USA at CMIC CMO Corporation, Interpharm Inc, and Dr. Reddy’s Laboratories, where I honed my expertise in clinical, pharmacokinetics, laboratory establishment and integrated product development, due diligence, site expansion/acquisition, manufacturing quality operations, quality systems management, product release processes, supply chain, change management, and design assurance across pharmaceuticals including OSD, Sterile Injectables, and Biologics/vaccine manufacturing domains. My academic foundation comprises a Doctorate degree in Pharmaceutical Sciences and a Master of Pharmacy complemented by various management certifications and a recent law degree. With a career spanning 26 years, I have continually demonstrated my adeptness in driving Quality, compliance remediation programs, audit and inspection readiness/management, implementing robust design controls and quality systems, and facilitating successful new product applications and launches. I have been instrumental in fostering sustainable quality operational strategies, instilling a culture of continuous improvement throughout the product life cycle, and nurturing the growth of quality operations, laboratories, and technical management. My leadership style is characterized by dynamism, strategic foresight, and a relentless pursuit of excellence. I have a proven track record of cultivating high-performance teams and optimizing efficiency while upholding exceptional quality standards and delivering superior customer service. I thrive in multicultural environments, leveraging my fluency and adaptability to steer global teams towards collective success. As I continue to evolve professionally, I am driven to infuse my wealth of experience, innovative mindset, and decisive decision-making into an organization poised for dynamic growth and global impact within the life sciences sector.

Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.

Overview

27
27
years of professional experience
6
6
Certifications

Work History

Head of External Manufacturing – India/Asia Pacific

CivicaRx
08.2024 - Current
  • I direct external manufacturing operations across India and Asia Pacific, ensuring affordable and timely delivery of drug substance, and drug product through CDMO partnerships. I lead startup, tech transfer, and commercial phases, negotiate strategic agreements, and build cross-functional teams to support quality, engineering, and inspection readiness. I oversee demand planning, supply chain alignment, and risk mitigation, while collaborating with CDMO and Civica’s program management to drive schedule adherence. I ensure compliance with Quality Agreements, coordinate audits and regulatory readiness, and prioritize resources to guarantee timely product release and execution of site master plans and capital upgrades aligned with Civica’s strategic objectives.
  • Key Achievements:
  • Strengthened regional manufacturing network by onboarding new CDMO partners for biologics and hospital products.
  • Successfully managed multiple tech transfers and inspection readiness programs, enabling rapid scale-up of supply nodes.
  • Improved operational efficiency at start up sites through targeted recommendations and implementation of best practices.

Head of Regional Biologics Quality Operations

Viatris
03.2020 - 04.2024
  • As the leader of Global Quality Operations, I oversaw Biological Drug Substance, Drug Products, and combination products, driving New Product Development and Launches. My role involved strategic and technical leadership to ensure sustainable quality and compliance across Supplier, In-house, and Customer Quality realms. I was a crucial member of the leadership team, supporting regulatory compliance and successful manufacturing operations while managing budgets and spearheading strategic plans for optimization.
  • (Viatris is a company formed by Mylan + Upjohn Pfizer)
  • Major achievements and participations during Employment:
  • As part of the Global Quality Operations team, providing strategic leadership and direction to six different partners across the world supporting the business operations, new product launches and release and disposition of products to over 30+ countries.
  • Implemented and optimized Quality Management Systems, communication channels, and compliance roadmaps, achieving a 95% on-time delivery rate and eliminating QMS backlogs entirely, while maintaining exceptional product quality.
  • Introduced collaborative platforms, review boards, investigator qualification processes, and robust CAPA management systems, resulting in a 70% decrease in issue recurrence and an 85% overall improvement in operational efficiency and real-time information dissemination.
  • Fostered team growth through training and skill development, instilling a culture of ownership and accountability, which boosted efficiency by 85% and enhanced On-Time Delivery (OTD) rates.
  • Drove continuous quality improvement initiatives, establishing dashboards, metrics, and KPIs, and fostering open communication and cultural transformation, resulting in sustainable business strategies and exceeding customer expectations.
  • Facilitated 25+ cGMP approvals, 17 successful regulatory audits (onsite and remote), and the launch and commercial support of over 3.75 billion doses across 35 countries, including the development of 8 new products.
  • Providing strategic and technical leadership to a team of approximately 35 senior management professionals and other Personal in Plant (PIP) across business functions, ensuring compliance, risk mitigation, and Inspection Readiness to safeguard the organization’s operational integrity.

Senior Director- Quality

Mylan
07.2016 - 03.2020
  • At Mylan, as a key stakeholder and integral member of the leadership team, I played a pivotal role in driving remediation efforts and ensuring sustainable quality and compliance operations. My responsibilities encompassed overseeing operations, implementing best practices, harmonizing processes, and orchestrating continuous improvement projects. Additionally, I provided strategic leadership to enhance facilities and capabilities, supporting successful manufacturing operations, timely new product development, launches, regulatory support, and inspections. My contributions were instrumental in facilitating on-time support for critical initiatives and maintaining operational excellence throughout various stages of product lifecycle management.
  • Major achievements and participations during Employment:
  • As Senior Director, provided strategic direction and support to quality, compliance, and manufacturing operations across five sites (each site comprising of about 500 employees), demonstrating leadership in aligning operations with business objectives.
  • Spearheaded the cultivation of a quality-centric mindset and the standardization of procedures and policies across the laboratory network, collaborating closely with commercial, R&D, Technical Services, Regulatory, and manufacturing operations. Successfully executed over 100 improvement projects resulting in significant reductions in manufacturing costs.
  • Pioneered the development of capabilities to support growth and enhance operational performance, leading a digital transformation journey that introduced e-Quality and laboratory systems, data integrity investigations, and lean systems. Achieved an 80% year-on-year improvement in operational performance.
  • Strengthened the documentation support team and implemented master data management strategies across the network, eliminating redundancies and facilitating on-time launches for over 30 products.
  • Established and supervised the laboratory testing and release function, aligning with new capabilities, centralizing operations, expanding facilities and capacity, and fostering cultural transformation and open communication initiatives. Resulted in sustainable, predictable, and on-time support for business operations.
  • Played a pivotal role in network-wide quality optimization projects, implementing visual boards, scheduling enhancements, STRT methodologies, laboratory management improvements, KPI tracking, CAPA initiatives, and reducing QMS backlogs by up to 60%.

Head-General Manager

Hospira | Pfizer Global Supply
12.2014 - 07.2016
  • As a member of the Leadership team at Hospira (acquired by Pfizer), I championed a culture of ownership and transparency, empowering teams through coaching on problem-solving, risk management, and continuous improvement.
  • Major achievements and participations during Employment:
  • As General Manager at Hospira, provided oversight of operations across three blocks (approximately about 600 employees in each block), demonstrating leadership in managing a team of approximately 160 employees.
  • Played a pivotal role in overarching laboratory optimization initiatives, encompassing the implementation of lean methodologies, visual management systems, scheduling enhancements, laboratory KPI tracking, and robust investigations and root cause analysis. These efforts fostered open communication and cultural transformation, facilitating the site’s quality remediation.
  • Led the implementation of critical laboratory digitalization journey such as LIMS, SDMS, and Global stability management, while also designing and expanding the infrastructure of the laboratory to accommodate increased capacities, supporting to address drug shortages, and meet customer demands strategically.
  • Overhauled and streamlined various systems, including QMS frameworks, to harmonize and refine workflows, eliminating bottlenecks and redundancies. These enhancements resulted in a remarkable increase in operational efficiency exceeding 40%.
  • Successfully managed more than four regulatory inspections and one joint regulatory inspection involving five different regulatory agencies, ensuring compliance and operational readiness across multiple sites.
  • Provided integral support for the day-to-day operations of diverse sites and suites, facilitating the delivery of over 100 million doses, demonstrating a commitment to operational excellence and patient care.

Head- Associate Director

CMIC CMO USA Corporation
04.2008 - 12.2014
  • Provided leadership within the quality organization to advance the company mission and objective to promote revenue, profitability, growth, and customer service/satisfaction.

Supervisor

Interpharm Inc.
10.2006 - 04.2008
  • Recruited in this position to contribute and manage to provide solutions to the complex problems in analytical and Quality control department involving method development, validation, and issues during the product life cycle.

Asst. Manager

Dr. Reddy's Laboratories Ltd.
01.2006 - 10.2006
  • Recruited in this position with reporting to Senior Director, to turn around the struggling team, towards a new direction of establishing the quality and compliance as well as to oversee the outsourced contracted work. Represented the Center of excellence as the subject matter expert for all the bioanalytical aspects, clinical pharmacology, and pharmacokinetics, quality related matters.

ADMET Scientist

Synchron Research Services
03.2004 - 01.2006
  • Hired to establish a new laboratory service and providing scientific directions to improve the overall laboratory functions and quality systems. Represented as the subject matter expert for all the Quality related matters, technical issues, troubleshooting and improving the bioanalytical pharmacokinetics aspects.

Senior Research Scientist

BV Patel PERD Centre | IAH&VB
09.1999 - 03.2004
  • Hired to drive the project and develop the team. Represented the institute and played a key role in establishing the biotechnological park, infrastructure, resources, securing projects/budget, mentoring people and leading variety of projects.

Education

Legum Baccalaureus (Bachelor of Law) - Law

Karnata State Law University
01-2026

Ph.D. - Pharmaceutical Sciences

Hemchandracharya North Gujarat University
Gujarat
01-2005

Master of Pharmacy - Pharmaceutical Sciences

Rajiv Gandhi University of Health Sciences, Government College of Pharmacy
01-1999

Bachelor of Pharmacy - Pharmacy

KLE's College of Pharmacy
Bangalore
01-1997

Skills

Friendly, positive attitude

Teamwork and collaboration

Computer skills

Customer service

Certification

Registered Pharmacist (KSPC)

RESEARCH PUBLICATIONS & CITATION

  • 9 Research publications with more than 1000 citations
  • 2 Inventory disclosures & Patents

Timeline

Head of External Manufacturing – India/Asia Pacific

CivicaRx
08.2024 - Current

Head of Regional Biologics Quality Operations

Viatris
03.2020 - 04.2024

Senior Director- Quality

Mylan
07.2016 - 03.2020

Head-General Manager

Hospira | Pfizer Global Supply
12.2014 - 07.2016

Head- Associate Director

CMIC CMO USA Corporation
04.2008 - 12.2014

Supervisor

Interpharm Inc.
10.2006 - 04.2008

Asst. Manager

Dr. Reddy's Laboratories Ltd.
01.2006 - 10.2006

ADMET Scientist

Synchron Research Services
03.2004 - 01.2006

Senior Research Scientist

BV Patel PERD Centre | IAH&VB
09.1999 - 03.2004

Ph.D. - Pharmaceutical Sciences

Hemchandracharya North Gujarat University

Master of Pharmacy - Pharmaceutical Sciences

Rajiv Gandhi University of Health Sciences, Government College of Pharmacy

Bachelor of Pharmacy - Pharmacy

KLE's College of Pharmacy

Legum Baccalaureus (Bachelor of Law) - Law

Karnata State Law University
PRASHANTH KUMAR