Nandakumar V S Email & Phone Number

Hyderabad Area, India

Cluster head for JV operations of Aurobindo Pharma Ltd., Currently working as cluster head for two JVs operations of Aurobindo pharma . Overall Plant operations consisting of Injectable, OSDs & Sterile API manufacturing, warehouse, plant SCM , Engineering, Future expansions projects, Budgeting, Operational excellence and MSAT Provide leadership and support two JVs, Eugia Pharma Specialities Ltd., and Auronext Pvt. Ltd., complying with regulatory requirements and in realizing business goalsJob Responsibility-Ensuring performance of manufacturing facilities by focusing on resource and capacity utilization, streamlining operations, process improvements and quality systems for delivering on OTIF.Reporting to Director Formulation & coordinate Business head to meet Business plan.Responsibility manufacturing operations of 7 injectable lines, 4 OSD lines and one Sterile API Combined manpower strength 500 + , More than 1500 SKUs from Oncology, Hormones and Penum- Optimize cycle time – number of days required for batch production to accept/reject final production output.- Strategize capacity scale up in line with requirements from BD- Responsible for on-going/future expansion projects or capacity additions, by avoiding any cost/time overruns.- OPEX budget optimization through value addition and continuous process improvements.- Spearhead Operational Excellence initiative and achieve business deliverables, by involving and collaborating with the stakeholders.- Environment , Health & Safety- Second line development for all critical positions ( N-1 level for HODs) in collaboration with HR- Effective Communication, being proactive and lead teams under pressure.- Diligence, attention in detail.NOTABLE ACCOMPLISHMENTS  Successfully Handling 5 regulatory audits of the facility. Preparation of expansion plan to meet commercial requirements.  Involved in launching of new products. 14 ANDS filing

Nusajaya, Johor , Malaysia

Heading drug product manufacturing plant . Responsibility include project completion, technology transfer from parent plant- customers labs and operationalize the Drug product manufacturing including WH- Commissioning, Qualification of equipment and facilities. Execution of Validations of systems.- Build organizational capabilities & a performance oriented work culture in the company. - Planning & ensuring execution of projects in line with the company’s strategic initiatives- Strategize with Plant and Corporate Supply Chain to meet COGs targets & monitor achievements- Working with Business development (BD) team to deliver on new BD initiatives- Strategize with R&D to meet set criteria of timeliness. - Ensures cross function synergies and support between teams to meet targets- Designing strategize to meet Internal and External customer satisfaction. - Team development : Identify , select, building manpower to meet the challenges. Develop team to meet the current requirement- New upcoming projects conceptualization, Budgeting, Selection of utilities and process equipments, Project execution.- Includes Over all budgeting of facility, procurement planning, vendor development, production planning.- Co-ordination with collaborators, partners , vendors and consultants for projects executions.- Lead Technology transfer activities between inter and intra Biocon teams

Bangalore

Designated as Senior Director Heading formulations, responsible manufacturing of Biopharmaceuticals, biosimilar formulation includes, Engineering & maintenance, Ware house operations including cold chain dispatches and SCMPresent Job profile : Create long term and short term strategy for the smooth operations in plant to achieve operational excellence.- Designing strategies for technical efficiency and cost optimization- Planning & ensuring execution of projects in line with the company’s strategic initiatives- Commissioning, Qualification of equipment and facilities. Execution of Validations of systems- Strategize with Plant and Corporate Supply Chain to meet targets & monitor achievementsEnsuring achievement of targets by Plant and Corporate Supply Chain with minimum down time and rejection.- Networking and business management. Working with Business development (BD) team to deliver on new BD initiatives- Strategize with R&D to meet set criteria of timeliness. - Build organizational capabilities & a performance oriented work culture in the company. - Ensures cross function synergies and support between teams to meet targets- Designing strategize to meet Internal and External customer satisfaction. - New up coming projects conceptualization, Budgeting, Selection of utilities and process equipments, Project execution .- Includes Over all budgeting of facility, procurement planning , vendor development, production planning, execution market requirements.- Co-ordination with collaborators , partners , vendors and consultants for projects executions.

Head Production, responsible manufacturing vaccine formulation and additional responsibility of overall plant operations as a factory manager.Continue in next page…….Job profile : Create long term and short term strategy for the smooth operations in plant to achieve operational excellence.- Planning & ensuring execution of projects in line with the company’s strategic initiatives- Commissioning, Qualification of equipments and facilities. Execution of Validations of systems- Strategize with Plant and Corporate Supply Chain to meet targets & monitor achievementsEnsuring achievement of targets by Plant and Corporate Supply Chain with minimum down time and rejection.- Networking and business management. Working with Business development (BD) team to deliver on new BD initiatives- Build organizational capabilities & a performance oriented work culture in the company. - Ensures cross function synergies and support between teams to meet targets- Projects conceptualization, Budgeting, Selection of utilities and process equipments, Project execution and - Includes Over all budgeting of facility, procurement planning , vendor development, production planning, execution market requirements.

Pune , India

A worlds largest manufacturer of conventional vaccine, Major supplier of DTP and MMR group of vaccine to WHO with export to 155 countries, Turn over of Rs 900Cr. Job profile : Deputy manager bacterial vaccine formulation and Reporting to Director formulations. Responsible for preparation of bulk formulations, filling and physical inspection. Responsible to combination vaccine formulation development, technology transfer and scale up Additional activity : Internal review committee’s member for Internal Quality Audit Team, CGMP committee and quality reviews committee.Member of Validation team for perform validation of sterilizer, cleaning procedures, process validations & testing procedure validation.Co-ordination with contract manufacturing sites, vendors and subsidiaries to meet market & quality requirements.NOTABLE ACCOMPLISHMENTS Involved in Design, equipment selection, commissioning of Hepatitis-B bulk and formulation facility. Successfully developed Hepatitis-B vaccine formulation and scale up to commercial batch volume. Successfully developed combination vaccines for children Involved in product registration from WHO Geneva for the same. Scale up of largest vaccine formulation batches of 2800L (5.6 million doses). Identified and implemented various critical in-process controls.  Successfully handled several WHO audits (Geneva) for Hepatitis –B and combination vaccine product registrations, for their immunization program.  Developed contract manufacturing base & involved in preparing technical papers related to licensing of contract manufacturing. Implementation of SAP in the production / PP module

Aurangabad Area, India

 Officer In-charge for Injectable department reporting to General Manager Production.  Day to day planning, work allocations, daily and monthly report preparation and over all administration of injectable department. NOTABLE ACCOMPLISHMENTS Implemented KAIZEN activity in the department. Distinction of handling/ executing key projects such as commissioning of new sterile area and filling lines.