SAI KUMAR BADAM
Monmouth Jn,USA
Summary
• 24 years of experience in Solid Orals (Tablets & Capsules), Liquid Orals (Suspensions & Solutions), Parenterals (Liquid & Lyophilized), Transdermal Patches, Topicals (Ointments & Creams), Oral Soluble Films, Suppositories and Active Pharmaceutical Ingredients (API) in Formulation and Analytical R&D, Development Quality Assurance and Quality Control activities in India and USA.
• Established Formulation R&D of Hetero Healthcare and API AR&D of Hetero Research
Foundation.
• Successfully transferred technologies of Oral disintegrated tablets, Transdermal patches and Oral soluble films to Plants.
Worked in Ohm Laboratories Inc., USA. (For technology transfer and given support in Method development for C-II and C-IV products).
Overview
24
24
years of professional experience
1
1
Certification
Work History
Team Lead
GUARDIAN DRUG COMPANY
12.2022 - Current
- Team Lead for ANDA products development and Validations in Formulation Analytical R&D
General Manager
HETERO HEALTHCARE LTD
07.2015 - 11.2022
- Worked as a HEAD of R&D and successfully leading a team of dedicated Formulation and Analytical-scientists
- Rich experience and exposure has enabled me to successfully undertake the task of planning and establishing of NEW LABS, CREATION AND IMPROVEMENT OF QUALITY SYSTEMS and New products planning and timelines etc
- Leading a team of 60 Scientists in Formulation R&D functional at HETERO HEALTHCARE LIMITED, HYDERABAD
- Ensuring smooth transfer of different dosage forms technologies from R&D to Plants
- Providing guidance, coaching and leadership trainings to FR&D and AR&D teams
- Responsible for the Timely and Quality delivery of Products
- Set up the Analytical R&D lab and successfully delivered several projects of different dosage forms
- Managing the team and experience in FORMULATION AND ANALYTICAL METHOD DEVELOPMENT along with STABILITY STUDIES AS PER ICH requirements
- To ensure smooth day to day operation of Formulation and Analytical development and monitoring of adherence to GLP by Scientists and Analysts in the laboratory
- To provide analytical support to formulation development department as required and provide guidance to subordinates for TROUBLE SHOOTING in METHOD DEVELOPMENTS, METHOD VALIDATIONS and other activities in Analytical development department
- Monitoring of PRODUCT EVALUATION AND REPORTING OF CQA (CRITICAL QUALITY ATTRIBUTES)
- Monitoring of ANALYTICAL METHOD TRANSFER TO QUALITY CONTROL in a timely manner
- Monitoring of STABILITY TESTING OF BIO/PILOT BATCHES and other Stability samples
- Review and Approval of various documents like SOP’S FORMATS, SPECIFICATIONS AND METHOD OF ANALYSIS etc
- Review and Approval of QUALIFICATION (IQ, OQ & PQ) REPORT for new instruments
- Experience in IMPURITY PROFILING, DISSOLUTION PROFILING AND STABILITY STUDIES for regulated markets
- Experience in COMBINATION PRODUCTS DEVELOPMENT
- Rich experience and exposure has enabled me success in delivering MULTI-DIMENSIONAL FORMULATIONS
- Responsible for end to end deliverables and timely completion of NEW PRODUCT DEVELOPMENTS by meeting Regulatory requirements
Asst. General Manager
MYLAN LABORATORIES LIMITD
01.2014 - 07.2015
- ESTABLISHED CENTRAL VALIDATION LAB with 20 analysts using e-documentation with Regulatory requirement
- Evaluation of GENOTOXIC IMPURITY AND METHOD DEVELOPMENT BY HPLC & GC
- Responding to the regulatory deficiencies within the stipulated time frame
- Resolving the ANALYTICAL RELATED QUERIES/DEFICIENCIES raised by regulatory authorities by developing suitable analytical methods and meeting their requirements for ANDA and DMF
- Conducting the CARRYOVER STUDIES of various impurities including Genotoxic intermediates, Raw materials etc
- In drug substance for DMF filing
Senior Manager
HETERO LABS LIMITED
09.2010 - 01.2014
- Company Overview: (Hetero Research Foundation)
- Responsible for planning and executing METHOD DEVELOPMENT for around 50 new products per annum
- Responsible for METHOD VALIDATION and ANALYTICAL METHOD TRANSFER to respective sites for smooth transfer
- Impurity profiling along with carryovers and Genotoxic studies support to regulatory queries on LC-MS/MS and GC-MS
- Responsible for executing STABILITY STUDY for the new products developed and provides Shelf-life, storage & packing condition for the products
- Responsible for ensuring cGLP (SOP’s) and EHS in Analytical laboratory
- Preparation of Analytical documentation, review of DMF & technical reports
- Manages Analytical Development staff by setting high personal, professional and ethical standards
- IP COORDINATION for IP related analytical issues
- QA /QC REGULAR COORDINATION for smooth transfer and monitoring validation batches progress
- Maintains permanently proactive interaction with Drug Regulatory Affairs to support REGULATORY FILING & POST QUERY RESPONSE
- PROJECT MANAGEMENT for identifying and allocating resources needed to support assigned project, allocates analytical resources to support development projects according to priorities, ensures participation of Analytical Development on project teams, and serves directly on such teams as needed
- Motivates staff by fostering creativity and innovation, by respecting collaborators, developing productive working relationships, and setting training programs
- (Hetero Research Foundation)
Manager
MATRIX LABORATORIES LIMITED
04.2007 - 09.2010
Sr. Research Chemist
RANBAXY RESEARCH LABORATORIES
07.2004 - 04.2007
Executive
AUROBINDO PHARMA LIMITED
09.2003 - 06.2004
- Worked in Quality Control Department
Analytical Chemist
Dr.REDDY’S LABORATORIES LIMITED
05.2000 - 09.2002
- Worked in Quality Control Department
Education
Ph.D - Chemistry
GITAM (Deemed to be University)
09.2019
M. Sc. - Applied Chemistry
Andhra University
08.1999
B.Sc - M.P.C
Andhra University
03.1996
Skills
Proficient in planning & managing resources
Adept at the cost effective analytical method development
Managing the Analytical Technology Transfers from R & D to QC
An effective communicator & team leader with skills in troubleshooting and team building
Accomplishments
- Secured Gold medal for first rank in Secondary School Certificate Examination
- Gold medalist in M.Sc.
- Established Formulation R&D of Hetero Healthcare
- Successfully transferred technologies of Oral disintegrated tablets, Transdermal patches and Oral soluble films to Plants
- Worked in Ohm Laboratories Inc., USA
Presentations
- ROLE OF NEW DELIVERY SYSTEMS IN DRUG INDUSTRY, Workshop conducted by DEPARTMENT OF CHEMISTRY, JNTU HYDERABAD COLLEGE OF ENGINEERING, Hyderabad
- TARGETED DRUG DELIVERY AND ITS APPLICATIONS, Presentation at BITS, Pilani, Rajasthan
- NANOTECHNOLOGY BASED DRUG DELIVERY AND ITS APPLICATIONS, Expert talk at Narasaraopeta Institute of Pharmaceutical Sciences, Andhra Pradesh, India
- NANOTECHNOLOGY: ENHANCEMENT IN DRUG DELIVERY, Presentation at ACHARYA NAGARJUNA UNIVERSITY COLLEGE OF PHARMACEUTICAL SCIENCES, Guntur, Andhra Pradesh, India
Career Overview
24, Solid Orals (Tablets & Capsules), Liquid Orals (Suspensions & Solutions), Parenterals (Liquid & Lyophilized), Transdermal Patches, Topicals (Ointments & Creams), Oral Soluble Films, Suppositories, Active Pharmaceutical Ingredients (API), Planning & managing resources, Cost effective analytical method development, Analytical Technology Transfers, Effective communication & team leadership, USA, Canada, Europe, Australia, South Africa, Brazil, India
Personal Information
- Date of Birth: 03/20/76
- Gender: Male
- Marital Status: Married
- Visa Status: H1B
Certification
Sai Kumar Badam, Battula Sreenivasa Rao, Satya Guru T.V.S.P.V, Suresh Maddila ; A Green and Eco-efficient protocol for the synthesis of benzo-[7]-annulene-1,3-dicarbonitriles by using simple mortar pestle grinding. SCIENCE DIRECT; ELSEVIER, Cleaner Engineering and Technology Volume 21, August 2024, 100762. https://www.sciencedirect.com/journal/cleaner-engineering-and-technology Direct Link: https://doi.org/10.1016/j.clet.2024.100762 (Impact Factor 7.8)
Sai Kumar B, Sreenivasa Rao B and Jyothi G; A Stability Indicating and Validated Reverse Phase High Performance Liquid Chromatographic method for the simultaneous estimation of Phenylephrine and Fexofenadine in Bulk and Tablet Dosage Forms. Asian Journal of Pharmaceutical and Clinical Research Vol 9, Suppl. 2, 2016, 144-148. ISSN: 2455-3891.
DOI: http://dx.doi.org/10.22159/ajpcr.2016.v9s2.13371. (Impact Factor 6.241)
(Citations: 1; Captures: 1)
Sai Kumar B, Sreenivasa Rao B and Jyothi G; A Validated Stability indicating and LC-MS Compatible Method for the Determination of Related Substances and Assay of Montelukast Sodium and Levocetirizine Hcl By U-HPLC in Tablet Dosage Form. Indo American Journal of Pharmaceutical Sciences, ISSN: 2349-7750, http://doi.org/10.5281/zenodo.1197081, IAJPS 2018, 05(03), 1368-1382; http://www.iajps.com. (Impact Factor 4.153)
(Views: 123; Downloads: 151)
Sai Kumar B, Sreenivasa Rao B and Jyothi G; A Validated Stability indicating Method for Determination of Related Substances and Assay of Penciclovir by RP-UPLC in Pharmaceutical Dosage Form. European Journal of Biomedical and Pharmaceutical Sciences; ejbps, 2018, Volume 5, Issue 4, 675-681; http://www.ejbps.com. ISSN: 2349-8870. (Impact Factor 4.918)
(Citations: 2; References: 3; Abstracts: 545; Downloads: 178)
Timeline
Team Lead
GUARDIAN DRUG COMPANY
12.2022 - Current
General Manager
HETERO HEALTHCARE LTD
07.2015 - 11.2022
Asst. General Manager
MYLAN LABORATORIES LIMITD
01.2014 - 07.2015
Senior Manager
HETERO LABS LIMITED
09.2010 - 01.2014
Manager
MATRIX LABORATORIES LIMITED
04.2007 - 09.2010
Sr. Research Chemist
RANBAXY RESEARCH LABORATORIES
07.2004 - 04.2007
Executive
AUROBINDO PHARMA LIMITED
09.2003 - 06.2004
Analytical Chemist
Dr.REDDY’S LABORATORIES LIMITED
05.2000 - 09.2002
M. Sc. - Applied Chemistry
Andhra University
B.Sc - M.P.C
Andhra University
Ph.D - Chemistry
GITAM (Deemed to be University)
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