Ashoka Ala Maison

运营VP/首席运营官住在 印度国籍 印度
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工作经历

vice president - manufacturing & operations

Granules India Limited
2023.09-至今(2 年)
• Leading the operations of the large manufacturing complex with capacity of2Bn dosages/month. Ensuring the compliance of products with global regulatory and quality standards. • Leading the teams during the inspections by global regulatory agencies, and customer quality audits. • Leading the efforts with the objective of meeting the top decile of POBOS benchmarks through the efficiency improvement initiatives by applying the principles of Lean and Six Sigma. • Leading the digitalization efforts of site with the objective of implementing relevant use cases to improve product quality, operational efficiency, and supply chain metrics. • Responsible for personal and professional development of associates.

site head - technical operations

Dr. Reddys Laboratories
2018.05-2023.09(5 年)
• Lead the formulations manufacturing sites which caters the products to US, Europe, and emerging markets. • Responsible for driving the efficiency improvement initiatives through Lean, and Six Sigma principles to meet the productivity and financial targets of site. • Responsible for ensuring the compliance with global regulatory standards, and local statutory requirements. • Successfully implemented Jishu-Hozen principles, and this resulted in site obtaining JH step 3 certification. • In addition to operations, lead the manufacturing science and technology (MS&T) function of oral solids cluster. Responsibility of this role includes all aspects involved in new product introduction, technology transfer, launch, and life cycle management of commercial products.

head - technical services

Glenmark Pharma Ltd, India
2017.03-2018.05(1 年)
• Responsible for overseeing all aspects of drug products Tech Transfer and commercial launch of all dosage forms across all geographies • Responsible for the life cycle management of commercial products involving active product remediation and re- validation • Responsible for managing global departmental budget to ensure planning and spending as per the established corporate operating expense goals, and in line with corporate processes

Site MS&T Head

Sandoz Inc., India
2015.08-2017.03(2 年)
• Responsible for robust product stewardship with end-to-end technical oversight of product manufacturing processes, at all stages of their commercial lifecycle • Fostered relationships with other site MS&T teams in the network for the application of standard work processes, best practices especially in validation, training, process changes, and in the handling of investigations resolution • Accountable to ensure that departments execute and maintain the VMP activities in their respective scope of responsibility, including, annual revalidation process and cleaning procedures • Responsible for leading cross-functional root cause analysis and problem solving on technical process issues (e.g., recurringdeviations, quality-investigations, CAPA-studies)

director - ms&t

Pfizer Inc., India
2013.07-2015.08(2 年)
• Successfully lead cross-functional teams (process development,automation, QA, procurement and manufacturing) in key phases of service agreement alignments, equipment selection processes, new technology opportunities, design, and qualification to meet the tight timelines of the deliverables • Responsible for technical leadership and project/team management for the completion of performance qualification, process shakedown and new product introduction/tech transfer through to process demonstration and validation • Efficiently lead efforts for the improvement, control, and monitoring of manufacturing processes by deploying PAT tools in the drug product and API manufacturing sites in India network • Lead cross-functional efforts for the closure of high impact investigations that arose from the exceptions during the qualification life cycle of equipment/process and manufacturing of exhibit/commercial batches. Developed appropriate mitigation strategies for addressing the root cause, and worked closely with responsible department for the implementation of mitigation plans

research investigator - drug product science & technology

Bristol-Myers Squibb Co., USA
2005.08-2013.06(8 年)
• Successfully lead cross-functional teams as technology transfer team leader during the design, development, and manufacturing of drug products. Worked closely with manufacturing sites across US and Europe during the technology transfer and implementation of process analytical tools to control and monitor the unit operations • Successfully carried out the formulation and process development activities of novel drug candidates in the QbD paradigm. • Successfully developed mathematical models based on the first principles for the simulation of powder blending, granulation, and tablet coating operations. • Developed formulation and process decision trees based on the material properties of the active ingredients. Platform formulations were developed based on the physico-chemical attributes of the novel drug candidates • Lead product development teams and effectively managed department deliverables with CRO’s and CMO’s

process engineer - technology transfer

Kos Pharma Inc, USA
2004.09-2005.08(1 年)
• Successfully piloted and scaled up pharmaceutical dosage forms. Designed, executed and interpreted experiments to ensure robustness of manufacturing processes for new pharmaceutical products • Supported development/selection of device components for inhalation aerosol technology platforms.

教育经历

Rutgers, The State University of New Jersey

Chemical and Biochemical Engineering

University of Mississippi

Chemical Engineering

College of Engineering, Andhra University

Chemical Engineering
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