Manufacturing Supply Chain

Kundan S Sengar

***, ****** ******* * , **** Chirec School

Kondapur ,Hyderabad– INDIA

Mobile +91-999*******

*************@*****.**.**

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CAREER OBJECTIVE

Seeking an Manufacturing operations management position in the pharmaceutical industries, to manage effectively all areas of Formulation Developments , Projects ,Plant production, Supply chain, Training, Engineering functions, Validations, cGMP regulatory compliance, safety and environmental standards and profitability of the organization.

SUMMARY OF QUALIFUCATION

Over twenty year’s successful quality, manufacturing, safety and environmental program management experience within major industry. The Initial 15 years working in a manufacturing facility (Tablets/Capsules/Liquid/ Ointments and Sterile) serving several different leadership roles from Supervisor to Manager and GM in major Pharmaceutical company like Ranbaxy / Alembic / Cadila / Sun Pharma /Glenmark.

Later Joined Aurobindo Pharma ltd (one of the India’s largest drug manufacturer and market cap of $ 4 billion) in 2006 as VP Operations in Aurobindo Pharma

During this tenure at Aurobindo I have implemented and developed comprehensive Operations System to meet US FDA standards and was instrumental in handling total Administration of Manufacturing, Technology transfer for 35 ANDA products. Successfully managed the Audits from USFDA and total Supply chain functions to maintain regular supply of Generics to USA market with high commitment to quality, productivity and Safety, finally instrumental in the setup of a New Project for Aurobindo Pharma in special economic zone location to cater contract manufacturing for Pfizer productions

Subsequent head as VP Operations for Jubilant Organosis where I initiated ANDA plant operations improvements programs. Demonstrated history of teamwork and independent project management skills necessary to successfully balance and complete multiple assignments while meeting all deadlines.

Now Head President to develop and scalup Project for Generic Oncology Injectable

Plant operations and approvals for all regulated markets

Personality Attributes:

• Conceptualizing, implementing start-up, growth & turn around

Strategies

• Strong enabling task master, leading from the front

• Constant excellence thru innovation & Cost Control

• Inspiring ordinary folks to perform extraordinarily in dedicated

Teams

• Scanning and managing the Physical and Regulatory environment

• First-hand familiarity with modern IT Networks and Analytical

Tools

Essential Functions Attributes

• Can oversee the Manufacturing, Quality Control and Assurance of drug substance, drug products and Product development business.

• Can oversee all aspects of product tech transfer and technical operations/ manufacturing and quality.

• Can Provide hands-on direction for all aspects of the manufacturing of Formulations, including vendor selection, contract negotiation, technology transfer, and process troubleshooting.

• Have Leadership of site cross-functional team at the site(s) responsible for the supply formulations in accordance with supply/ demand plans.

• Can Manage cost of goods and budgets.

• Can Present Report to Executive Management through appropriate updates/reports, including defined and maintained metrics.

• Can implement operational excellence/ system improvements to continuously improve site operations.

• Can provide proper oversight to the Tech Transfer team.

• Can Provide strategic planning input to Management

• Can manage interactions with other functional areas such as PD, R/D and Regulatory.

• Plan Monitor performance on contracts and milestones to ensure successful delivery of products against time, quality and cost considerations.

• Can Assist Regulatory Affairs to author certain sections of regulatory submissions.

• Can organize and conduct facility and manufacturing due diligence on in-licensing product candidates.

• Can Assist Regulatory Affairs to manage all aspects of validation activities required.

• Carry out cost reduction efforts through optimizing tooling, processes and materials.

• Work with Business Development and 3rd parties in sales efforts to represent manufacturing and Quality Operations

PROFESSINAL EXPERIENCE

• Manage 500 employees, including 25 Executives / supervisors and 8 managers.

• Managed the following Operations in Aurobindo Pharma

Handling Commercial batches for US and EUROPE

• With 25 million USD /month turnover from unit 3 location in Aurobindo Pharma

• Deliver significant improvements accuracy through streamlined procedure and employee training.

• Improved FDA-483 compliance over 50% during re-inspection.

• Key functional responsibilities include effective utilization of Man / Machine and materials to achieve total operational goals.

• METERIC STREAMS system for total QMS control in the plant

• Responsible for maintaining Validation Master Plan including area qualification of newly builds facility.

• Managing real time review of batch manufacturing record on production floor.

• Ensure timely, efficient and accurate review and release of finished products to commerce. Meeting the company monthly goal while maintaining quality and compliance throughout the product release processes in accordance with good manufacturing practices as outlined in 21 CFR Parts 210 and 211.

EDUCATION

BS in Pharmacy

Dr HS Gour University of SAGAR India 1986

Ms in Pharmacy Dr HS Gour University SAGAR India 1988

PROFESSINAL DEVELOPMENT

• Training for TEAM Building

• FDA inspections All time readiness from ISPE

• QMS systems for FDA / Meteric Streams QMS for total CAPA operations

• Good Manufacturing Practices Training by lachman consultants

• Understanding the basic of CFR Part 11 compliance

• Undergone Managerial Grid (Blake and Mount)

• Interpersonal Skills Workshop

TRAVEL to Germany, China, Sigapore, Far East, South Africa

Kundan Singh Sengar

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