Ashoka Ala Maison
男运营VP/首席运营官住在 印度国籍 印度
分享
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
搜索简历
国籍
职位类别
城市或国家
排序
联系方式
91****1009
ni**@**om
成为会员即可解锁简历
也看过