Rakesh Kumar Sinha Email & Phone Number

Hyderabad, In

Hyderabad, Telangana, India

My current role encompass of supervising the vaccine fill and finish operations, including working closely with teams from various departments to ensure adherence to regulatory guidelines and quality standards. Responsible for ensuring adherence to production schedules, inventory levels, and resource distribution to achieve production targets. Additionally, I lead efforts for ongoing enhancements in capacity utilization & creation and quality within fill & finish operations.In my role as the Head of Fill & Finish Operations, I oversee a entire vaccine manufacturing with a capacity exceeding 1Bn. doses annually. Our production includes approximately 300 Mn. vials & ampoules annually. Leading a highly skilled team, managing a diverse range of complex injectables & transforming profitability through implementation TQM Principals |POBOS Benchmarks meeting & exceeding - cost leadership, quality compliance, operational efficiency. Besides, I successfully increased vaccine throughput, surpassing annual turnover targets, enhanced profitability & achieved a significant reduction in conversion costs leading to improvement in the site's gross contribution. Introducing new products like Novel Oral Polio and Phneubevax-14 has expanded our portfolio, I have led the commercialization of products from new facilities to meet market demands effectively, while maintaining fiscal discipline, stringent quality standards and reducing cost of poor execution. By embracing technological advancements and orchestrating successful product launches, I drive business growth, while ensuring compliance with factory regulations and GMP standards for operational integrity and excellence. In summary, my leadership has been instrumental in achieving significant milestones in production efficiency, cost reduction, product diversification, market alignment, and quality compliance within the pharmaceutical manufacturing sector.

Naidupeta, Andhra Pradesh, India

During my tenure at this organization, I was integral in steering and supervising the organization's strategic direction and decision-making processes. Working closely with fellow board members, I contributed to the creation and execution of strategic plans and initiatives. I offer leadership and direction on governance matters, ensuring adherence to regulations. Additionally, I oversee financial performance and uphold fiscal responsibility.During this tenure, I have established, overseen, and launched a state-of-the-art new production facility that complies with all regulatory requirements for solid dose and liquid oral products. This facility has successfully processed more than 18 batches and has received approval from the WHO under the NRA. I have obtained all necessary approvals for manufacturing, electrical systems, pollution control, building stability, fire safety, and load capacity.I lead and successfully resolved many disputes with suppliers & contractors, arisen due to difficult COVID-19 situation, that proved pivotal in successful completion green field project at Naidupeta, Andhra Pradesh.

Baddi, Himachal Pradesh, India

As site head, I was in charge of supervising the day to day operations' for the company. In addition, I lead and manage a group of team, handling tasks like recruitment, training, and performance assessments. I also create and execute plans to achieve the operational objectives established by the company. It is my responsibility to guarantee adherence to company policies, protocols, and safety measures at the location.Throughout this procedure, I achieved a significant increase in throughput, raising site turnover, surpassing planned goals. Achieved improvement in financial indicators such as Plant Operating expense to throughput ratio from 16 to 12, Asset Turnover Ratio from under 3 to 4.9, optimizing resource usage and capital efficiency. Production volumes were boosted significantly - Injection went from under 3Mn. to 50Mn, Topical from under 5Mn. to 16Mn., and Oral Solids from 1.4Bn to 2.5Bn annually. Product availability was consistently high, with OTIF maintained above 95 for all dosage forms. I implemented strong quality operations, ensuring regulatory compliance and reducing costs related to poor execution. I led efforts in improving efficiency and productivity among employees, resulting in a Plant Level OEE of over 48 across all unit operations. Through various initiatives, reduced footprint, and energy consumption, I achieved OpEx reduction while spearheading the automation of Packaging Operations for Tablets Capsules, Topicals, & Injection on all packaging lines.Successfully improved Quality Culture , Cost Leadership, OEE, DILO, Autonomous Work Place to drive plant operations into Top Quartile (POBOS Benchmarking Standards).

Panelav, Baroda

My role involved creating & executing projects plans for green field Oncology OSD & injectable facility, ensuring execution of First to File EBs | Pivotal Batches for US Market. I oversaw the establishment and certification of a state-of-the-art Green Field Facility that met US-FDA standards for both oral solid dose (OSD) & injection production. I also took charge of commissioning & validating cutting-edge Injection and OSD Isolator Facilities designed for high potency drugs. I completed the commissioning of the Bosch Isolator Fill & Finish Line for injections in record time of one year from Factory Acceptance Testing (FAT) to Validation, that earned high praise from management. Bosch's German Team termed it as 'Fastest Ever' Injectable Isolator Project Execution. I successfully managed the timely execution of First Time Filling (FTF) exhibit batches for Palbociclib, Osimertinib, etc, aligning with our strategic objectives., including obtaining US-FDA approval for the FTF-Palbociclib in Oral Solids Facility, ensuring strict compliance with regulatory requirements. Additionally, My role involved creating and executing operational plans, handle budget, resources, and timelines to achieve operational targets. Collaboration's with different departments to guarantee seamless operations and promote ongoing improvement efforts has been a hall mark.

Aurangabad, Maharashtra, India

My role involved supervising & controlling all manufacturing operations to guarantee simplify production processes, quality assurance & on-time product delivery. Besides, I provide leadership and guidance to a group of manufacturing experts, establishing definitive goals and targets for the department. I tracked and enhanced manufacturing performance, productivity, and cost-effectiveness by monitoring KPIs. My responsibility also includes ensuring adherence to safety regulations and optimal practices in manufacturing activities.During my tenure, I successfully turned around a loss making site, making it profitable and significantly increasing revenue streams. Operational efficiency was greatly improved, with throughput increasing from 45Cr to 140Cr. I also managed to reduce plant operating expenses, improving the expense from 124Cr to 52Cr. Production volumes were significantly increased, with Injection production going from 3.6M to 60M and Liquid Orals from 7.2M to 12M annually. Successfully completed the US-FDA OAI Remediation for multiple plants under guidance of US-GMP Consultants Lachman, Quantic and Step Change Parma. Regulatory inspections by MHRA HPRA EMEA Russia were successfully completed for both Liquid Production Facility and Insulin Injection Facility. Additionally, I executed Phase-I & II CT batches for NCE QIDP Products, and Biosimilar Products

B.Pharma, Pharmaceutical

Master Of Science (Ms), Pharmaceutical Operations & Management