Ramachandram Gunji
Head of Global External Manufacturing Operations
Hyderabad,Telangana
Summary
Experienced professional with over 22 years of expertise in general management, business development, external manufacturing operations, and R&D technology transfer within the pharmaceutical industry. Proven track record in establishing and overseeing strategic partnerships for generic, specialty, and novel pharmaceuticals to drive successful commercialization in global markets. Skilled at navigating complex industry landscapes and leveraging market insights to drive business growth and achieve organizational objectives.
Overview
24
24
years of professional experience
9
9
years of post-secondary education
4
4
Languages
Work History
Head of Global Third Party Operations
Xellia Pharmaceuticals Aps
Hyderabad
09.2014 - Current
- Entrusted to oversee end-to-end commercial manufacturing of different dosage forms of injectable formulations including PFS, Lyophilized vials, Sterile dry powder and premix bags at contract manufacturing operations located in India.
- Acting as Virtual Site Head for CMOs delivering an external supply of drug products complying with high standards of quality and regulatory compliances.
- Chairing business review meetings, where key stakeholders and technical experts meet to discuss joint opportunities, potential roadblocks to collaboration, activities, and resources required and share strategies and relevant market trends.
- Lead major projects to improve supplier performance, manage the performance of the suppliers, set targets for the suppliers’ KPI dashboards, set goals for SRT (Supplier Relation Team) members with functional heads, review KPIs with suppliers and internal teams, and serve as the primary point of escalation for issues/KPIs.
- Ensure implementation of CAPAs, art works, change controls and communicate issues with suppliers to avoid supply disruptions due to lack of planning and communication.
- Provide technical expertise in areas of responsibility, coordinate across functions and leadership teams, and assure the SRT has 'one voice' to third parties.
- Manage multiple complex projects, and effectively communicate progress and risk to leadership - No delays in timely execution of the projects and launch of new products.
- Support areas of deviation investigations, change controls, and CAPAs, ensuring adherence to manufacturing schedules and timely batch releases. OTIP performance has been significantly increased to 98%-100%.
- Drive continuous improvement initiatives including technology optimization and COGs reduction activities resulted in over 1MUSD savings year on Year.
- Managing technology transfers and leading several initiatives and projects within the ESO (External Supply Operations) by effectively collaborating with different Cross functional Teams.
Manager – Global External Manufacturing & Outsourcing
DR. Reddy’s Laboratories Ltd.
Hyderabad
07.2001 - 09.2014
- Ensured strategic planning and execution of production plans and material movement at CMO sites (4- 5 CMO sites)
- Monitored product yield for continuous improvement & simplification of processes for improved product yields by more than 95%.
- Coordinated with in-house CFT (Cross Functional Team) and Contract Manufacturer’s CFT for smooth transfer of technology and validation of processes for several In-house R&D developed products for submissions to filing and Launches(10 -15 new products launched from CMO sites yearly)
- Ensured cGMP in all aspects of product manufacturing, quality control, and packing operations carried out at external manufacturing sites without any recalls and batch rejections.
- Managed change control, monitored deviations, and market complaint investigations and CAPA implementations to ensure smooth Supply Chain Operations at CMO sites with OTIF performance of above 98%.
- Identified potential contract manufacturing partners for commercial tie-ups for outsourcing/in-licensing of new products for increased upside business potential and contingency risks.
- Pioneered and implemented an operational excellence program with CMO partners for excellent cost savings opportunities and simplified processes.
- Pioneered in Critically reviewing the project scope for spotting anticipated issues for their timely resolution to ensure smooth execution and launch of several first-time generic products for regulatory markets out of CMO sites
- Led, developed, and coached team members to be independent while supporting them when needed
- Successfully negotiated and finalized many commercial agreements with potential partners and AVD (Alternate Vendor Development) for business expansion & risk management and cost optimization.
- Served as a senior mediator to improve collaboration where alignment with suppliers or customers was required
Education
Executive MBA - Operations and Supply Chain Management
Narsee Monjee Institute of Management Studies
Mumbai, India 01.2021 - 02.2023
M Pharm - Biotechnology
Jawaharlal Nehru Technological University
Hyderabad 01.2008 - 01.2011
B Pharm -
Govt. College of Pharmacy
Bangalore, Karnataka 01.1996 - 01.2000
Skills
- Contract/ External Manufacturing
- Global Sourcing (Emerging Markets)
- Operational Excellence (Green Belt Lean/ Six Sigma)
- Strategic Negotiations (Selling & Buying)
- Project/ Process Management
- Intercultural Sensitivity
- Supply Chain/ Planning/ Logistics
Accomplishments
- Received several high-recognition awards and appreciation for various successful execution of high-level Injectable projects at Contract Manufacturing Operations (CMO) including the prestigious chairman’s excellence award for successful execution and Launch of the world's first generic drug product Fondaparinux inj PFS in the US from Dr.Reddy’s Laboratories Ltd
- Received 6 promotions within the span of a 10-year career at Dr.Reddy’s Laboratories Ltd
- Received 7 times valued contributor award and many other awards from Dr.Reddy’s Laboratories Ltd for successful accomplishment of various projects
- Successfully coordinated technology transfers and execution of many First-time Generic drug products out of CMO sites for US, EU, and other RoW markets
- Successfully steered Serialization implementation at CMO sites in record time
- Improved and maintained On-Time-in Full(OTIF) delivery with Contract manufacturers >98%
- Ensured business continuity for Xellia by initiating and leading the global supply risk mitigation program from early 2020, ensuring no market stockouts due to materials, services, or CMO supply risks
- Established excellent supplier relationships and built partnerships with key CMOs and suppliers
- Invented ideas for products Continuous Improvement (CI) for ease of operations and highest yields and cost savings exceeding 1Mn USD year on year at CMO sites at Xellia
- Demonstrated highest level involvement, problem-solving skills, and out of box thinking to resolve various issues for continuous supply chain operationsReceived several high-recognition awards for successful execution of high-level Injectable projects.
- Received 6 promotions within a 10-year career at Dr.Reddy’s Laboratories Ltd.
- Received 7 times valued contributor award from Dr.Reddy’s Laboratories Ltd.
- Successfully coordinated technology transfers for First-time Generic drug products.
- Improved and maintained On-Time-in Full (OTIF) delivery with Contract manufacturers >98%.
- Established excellent supplier relationships and built partnerships with key CMOs.
Trainingcertificates
- Six Sigma Green Belt Certification
- Silver certification for project PACE at Dr.Reddy’s laboratories
- Certifications for various trainings on cGMP, Pharmacovigilance, cyber security awareness
Timeline
Executive MBA - Operations and Supply Chain Management
Narsee Monjee Institute of Management Studies
01.2021 - 02.2023
Head of Global Third Party Operations
Xellia Pharmaceuticals Aps
09.2014 - Current
M Pharm - Biotechnology
Jawaharlal Nehru Technological University
01.2008 - 01.2011
Manager – Global External Manufacturing & Outsourcing
DR. Reddy’s Laboratories Ltd.
07.2001 - 09.2014
B Pharm -
Govt. College of Pharmacy
01.1996 - 01.2000