ANIL DEVARAJ
Bangalore
Summary
Goal Oriented Chemical Engineering professional with over 28 years of experience in Manufacturing Operations/Site Operations, Process Development/Excellence, Supply Chain Management, Technology Transfer, Process Enhancements, EHS activity/sustainability and Manpower Mentoring which provided great opportunities & revenue growth.
Overview
26
26
years of professional experience
Work History
Site Head Operation
Almelo Chemical Limited
Hyderabad
01.2024 - Current
- Was Successful in meeting Regulatory Audits Korean FDA & USFDA working with Zero 483s with Risk Assessment & implementation of critical to Quality requirements across the Site Coordinating with Site Leadership Teams from Quality Assurance,
- Successfully scaled up products like Dabigartan & oncology molecules like Imatinib Mesylate Alpha for Remedica,Pazopanib ,Sorafenib Tosylate ,Dasatinib,Nilotinib,Dasatinib & Abireterone Acetate with detailed Risk Assessment & addressing Scale up concerns on time
- Sucessfully plugged in variations in Quality & Safety with detailed Investigations to address the Gaps timely, Mentoring the Team with Trainings & Feedback Mechanism on continous basis
- Implemented monitoring & control of Inventory stocks to Ensure continous Production & Delivery in time
- Streamlined Ware House Processes to Ensure continous reliability of Operations through continous tracking & Quality implementations
- Implemented Compatibility of material stored at Ware House & Proper dissipation practices which are critical to Safety
- Handled 3 production Blocks which included Oncology & Regular API Blocks s.Total Revenue handled 400crore revenue/annum and 300 plus manpower company and contract
General Manager Manufacturing & Site Head
Aurore Life Sciences Pvt Ltd
Hyderabad
12.2023 - 02.2024
- To lead manufacturing operations of the site,responsible for profit and loss of plant
- Responsible for planning the production and operational activities simultaneously enabling procurement/scm for seamless business requirements
- Responsible for WHO audits ,factory license, statutory compliance
- Streamline the operations in the most cost optimize manner
- Maximum resource utilization and manpower planning to optimize the cost of production
Vice President Operations & Site Head
Sami Sabinsa Nutraceuticals Pvt Ltd
Hassan
01.2022 - 09.2023
- Started Operations of a Nutraceutical Manufacturing Company from Green field Projects
- Responsible for coordinating with Vendors, Company management & liaison with Government authorities for CEIG Approval, Power Sanction, Boiler Firing certificate, PESO (Petroleum & Explosives Safety Organisation) Approval, Factories Department Approval, Consent for Operations & Manufacturing License Approval
- Led the Site Team for Calibration, Qualification & Commissioning of all Equipment's & utilities
- Equipment's included Reactors (Glass lined & Stainless steel), Hydrogenators, Centrifuges, Sparkler Filters, Agitated Nutsch Filter Driers, Rotary Cone Vacuum Driers, Tray Drier, Multi Mill & sifters
- Guided for Qualification & Commissioning of utility systems like HVAC System, Cooling Tower water, Chilled water System, Chilled Brine system, Vacuum Pumps, Hot Oil System, Compressed Air & Nitrogen Plant
- Implemented Standard Operating Procedures & set up Production, Ware House, Quality Control, Quality Assurance & Human Resource functions
- Coordinated for Drug Manufacturing License Audit from Central & state Drugs Standard Control Organisation & obtained certification with few minor modifications
- Completed the Trial & Validation batches of initial Products & start Commercial manufacturing
- Handled around 250plus manpower from company and contract
General Manager Production & Warehouse
Cdymax Pharma Pvt Ltd
Bangalore
03.2019 - 12.2021
- Successfully meeting Production Delivery Schedule with Quality & Safety, Meeting Customer expectations of Quality, Particle size parameters & within predetermined consumption norms
- Meeting the complete Capacity of MultiProduct blocks with detailed planning annually, Quarterly & monthly on time & in full
Deputy General Manager Manufacturing
Aurobindo Pharma Ltd
Srikakulam
11.2015 - 01.2019
- Successfully managed to improve the production of Rosuvastatin Calcium from 200 Kgs/Month to 1.5 Ton/Month
- Troubleshot critical molecules such as Esomeprazole Magnesium Dehydrate,Rosuvastatin Calcium, Risedronate Sodium, & Pioglitazone targeting Strategic Business requirements on time
- Implemented Good Quality Practices across manufacturing Blocks with Prime Focus on online Documentation & Control through continous monitoring & Control through Audit
- Administered Hazardous chemicals & reactions such as Hydrogenation with Risk Assessment & detailed Safety implementations targeting on Near Miss Controls as a Safety Index
- Commissioned R & D for scale up critical molecules by conducting Quality & Safety Risk Assessments coordinating with R & D and Engineering Departments
- Coordinated with R & D for getting Essential Negative Experiments on time & with Engineering Department for Completing Engineering requirements
- Coordinated with inter departmental Leadership team as a key member for closing Quality OOS & OOT on time through continous discussions & Brainstorming sessions
- Mentored Production Managers ,Safety Managers & Documentation Team for Ensuring Productivity & Safety across Production Blocks
- Handling Critical Safety Reactions like Hydrogenation & Hazardous Chemicals like Lithium Aluminium Hydride & n butyl litium
- Developing project plans & schedules and tracking & reporting progress, formulating detailed status reports
- Defining the Standard Operating Procedures (SOPs) to prevent issues and meet quality management standards
- Facilitating invoicing management, pricing support, budgeting/ forecasting support, revenue recognition, and financial analysis
- Presenting varied analysis for identifying scenarios of optimal profitability, discussing recommendations and providing project financial advice
- Mentoring, leading & monitoring the performance of team members to ensure efficiency in process operations
- Managed 600 persons in 8 manufacturing Blocks delivering consistently Quality Products utilizing the facility to optimum Extend & in Full for 3 & Half years
- Handled 500 crore revenue/annum and 700 plus manpower company and contract
Manager Production for Multi purpose DCS Facility
Jubilant Life Sciences
10.2012 - 10.2015
- Administered the critical molecules such as Irbesartan, Losartan, Pinavarium Bromide, Bupropion Hcl & Pantoprazole Sodium
- Facilitated scale-up for molecules such as Pantoprazole in the new route with estimated cost savings of INR 6000/Kg
- Expanded production yield by establishing critical parameters for various runner products such as Irbesartan & Losartan thereby reducing the cost from INR 5500/Kg to INR 3200/Kg
- Established & stabilized the capacity production of Irbesartan from 6.0T/Month to 10.0T/Month
- Scaled up the processing stages of various products such as Pinavarium Bromide, Bupropion Hcl & Pantoprazole Hcl
- Streamlined the production activities with various systems to a production yield of 10.0 Tons
Plant Manager
Kumar Organic Products Ltd.
Hassan
11.2011 - 09.2012
- Started Company from Green Field Projects & started Production involved in Liasoning with Government agencies for Electrical Approval, Boiler Provisional certificate, Consent for Operations, SEZ & KIADB agencies for getting special Provisions & Approvals
Senior Manager Process Safety
Matrix Mylan Laboratories
02.2010 - 11.2011
- Conceptualized & set up Process Safety Lab with advanced equipment such as Reaction Calorimeter, Phitec 1 (Adiabatic Calorimeter) & Powder Testing Equipment
- Gained working experience in Reaction Calorimeter & ARSST
- Conducted Risk Assessment across locations with focus on Bottom-line & Critical Reaction Automation
Deputy Manager Technical Services Department
Dr. Reddy's Laboratories Ltd
Hyderabad
10.2007 - 01.2010
- Conferred with 'Chairman's Excellence Award,' for scaling up Gemcitabine Project, 2008-09
- Facilitated Technology Transfer & Technology absorption for various API /HPAI (Cytotoxic) molecules under cost improvement program
- Trouble shooting at Vendor locations
- Administered documentation related to Trial / Validation batches
- Achieved BD (Bulk Density)/PSD (Particle Size Distribution) as per customer requirements by validating micronization parameters
- Debottlenecked and conducted root cause identification related to various process problems such as OVI failure/ crystallization studies/ failure in unknown impurities & so on for various API products
- Conducted Hazop study based on CIBA recommendations
Assistant Manager
Max India Ltd
01.2000 - 10.2007
- Facilitated modification activities & Hazop of Carbamazepine & Oxcarbamazepiene
- Administered various reactions such as Hydrogenation, Hydrolysis, Oxidation, Condensation, Sulphonation, Hazardous Sulphur Reaction & maintained Scrubber
- Re-established operations of Larox Plate & Frame Filter Press, imported from Finland
- Led production activity of Carbamazepine by reworking on 2nd crops for getting USP grade Carbamazepine
- Streamlined NEPL grade Carbamazepine production with improved consumption norms
- Part of a member a team that facilitated USFDA approvals of Lamotrigine manufacturing facility
- Contributed in preparation and execution of monthly production plans & targets of 17000 Kgs
- Conducted 'Aspect-Impact Analysis' of production activities as a core team member of ISO-14001
- Assisted in various Six Sigma Projects such as Yield Improvement in ISB Stage
- Was trained as Six Sigma Black Belt under Velocity Projects
Chemical Engineer
Gujarat Vet Pharma Products Ltd
Ankleshwar
12.1998 - 01.2000
- Participated in the production of pesticides with a team of 10 employees
- Responsible for Project activities & later moved over to Production
Education
BE -
Chemical
EMBA -
Operations Mgmt
PG Diploma -
Industrial Safety
PG Diploma -
Production Management
Strategic Management -
XLRI
JamshedpurEnvironment Mgmt -
Mysore University
MysoreSkills
- Operations Management
- Technology Transfer
- Scale up
- Process Safety Management
- Supply Chain Management
- Liasoning with Government
- Regulatory Audits - USFDA, MHRA
- Quality Management/Safety Management/EHS
- Mentoring & Leadership
- Budgeting
- Quality/Safety Risk Assessment
- Continuous Improvement
Extracurricular Activities
Represented Karnataka state in Nationals Badminton, 1989 General Secretary Chemical Engineering Department, SIT Tumkur, 1996-97
Training
- Attended Training on Data Integrity in Pharma Industries
- Safety Audit from National Safety Council, Karnataka Chapter, Bangalore
- CGMP by A. K. Sabharwal, President-Pharmaffiliates Asia Research Foundation
- First Aid Training from St. John Ambulance Association
- Fire Prevention & Fire Fighting from WHEN-IT-STRIKES, Crisis Management Pvt. Ltd.
- Leadership Skills Development by Stimulus Consulting
- Safety Auditing by Chilworth Consultants
- Training on Risk Analysis by Ciba Consultants
- Member of Centre of Chemical Process Safety
- Trained in Implementation of Quality in Investigations of OOS/OOT/CAPA
- Trained as a AuroLeader for 360 Degree Leadership Grooming by Aurobindo in 2018-19
Languages
- English
- Hindi
- Kannada
- Malayalam
- Telugu
Personal Information
Date of Birth: 09/04/73
Timeline
Site Head Operation
Almelo Chemical Limited
01.2024 - Current
General Manager Manufacturing & Site Head
Aurore Life Sciences Pvt Ltd
12.2023 - 02.2024
Vice President Operations & Site Head
Sami Sabinsa Nutraceuticals Pvt Ltd
01.2022 - 09.2023
General Manager Production & Warehouse
Cdymax Pharma Pvt Ltd
03.2019 - 12.2021
Deputy General Manager Manufacturing
Aurobindo Pharma Ltd
11.2015 - 01.2019
Manager Production for Multi purpose DCS Facility
Jubilant Life Sciences
10.2012 - 10.2015
Plant Manager
Kumar Organic Products Ltd.
11.2011 - 09.2012
Senior Manager Process Safety
Matrix Mylan Laboratories
02.2010 - 11.2011
Deputy Manager Technical Services Department
Dr. Reddy's Laboratories Ltd
10.2007 - 01.2010
Assistant Manager
Max India Ltd
01.2000 - 10.2007
Chemical Engineer
Gujarat Vet Pharma Products Ltd
12.1998 - 01.2000
BE -
Chemical
EMBA -
Operations Mgmt
PG Diploma -
Industrial Safety
PG Diploma -
Production Management
Strategic Management -
XLRI
Environment Mgmt -
Mysore University
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