SSN RAJU MANTENA
Hyderabad
Summary
Looking forward to better prospects, Opportunity and work innovatively on Pharmaceutical product Development in the area of Drug Delivery and Generic Dosage Forms utilizing the principals of :
• Failure Mode and Effect Analysis (FMEA)
• Design of Experiments (DoE)
• Quality Target Product Profile (QTTP)
• Critical Quality Attribute ( CQA)
• Quality Risk Management
• Design Space
Overview
19
19
years of professional experience
Work History
Head of the Department, Analytical R&D
Novick BioSciences
12.2023 - Current
- Developed detailed plans based on broad guidance and direction as per Client requirements
- Defined clear targets and objectives and communicated to other team members.
- Launched quality assurance practices for each phase of development
- Successfully managed budgets and allocated resources to maximize productivity and profitability.
- Established team priorities, maintained schedules and monitored performance.
Analytical Expert
Dr. Reddy’s Laboratories
12.2018 - 09.2023
- Handling a team of 8 Scientists for generic product development of modified release oral solid dosage forms and filing ANDA’s to US FDA.
- Providing support to incidence investigation occurring at different plant locations during Analytical Method Transfer/Method validation at different plant locations.
- Management of analytical method validations for finished product and raw materials in contract testing laboratory.
- Evaluated and implemented new technologies and laboratory techniques to improve quality and robustness of sample analysis.
Analytical Expert
Dr. Reddys Laboratories
03.2016 - 12.2018
- Handling a team of 7 Scientists addressing deficiencies received after filing of ANDA for oral solid dosage forms.
- Root cause identification of incidence by using different techniques like 5-WHY and FMEA techniques.
Analytical Expert
Dr. Reddy's Laboratories
11.2013 - 03.2016
- Handling a team of 5 Scientists for generic product development of oral solid dosage forms and filing ANDA’s to US FDA.
- Developed laboratory testing programs and data analysis while adhering to SOPs, batch records and work instructions.
- Collaborated with supervision, engineering and other personnel on quality and performance improvements.
Analytical Scientist
Dr. Reddy’s Laboratories
12.2008 - 11.2013
- As a development scientist responsible for product development of various oral solid dosage forms and filing to USFDA
- Prioritized project tasks after discussions with FR&D team.
- Read literature related to scientific area of expertise to remain current in knowledge.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Modified and adapted standard methods and procedures to solve analytical problems.
Associate Scientist
Lupin Research Park
09.2005 - 12.2008
- As a analytical scientist, responsible for validation of various analytical methods in solid Dosage forms.
- Documented all processes during experiments, keeping meticulous notes of changes that were unexpected.
- Performed intricate research within strict timeline and communicated results to stakeholders.
- Leveraged scientific knowledge to support formulation development.
Education
Six Sigma Green Belt -
American Society For Quality
06.2015
M.Pharmacy - Pharmaceutical Analysis
Dr. MGR Medical University
09.2005
Post Graduate Diploma in HR Management(PGDHRM) -
University of Pondicherry
12.2004
B.Pharmacy -
Shri Vishnu College of Pharmacy
04.2003
Certified Scrum Master
11.2023
Skills
- Method development
- Method validation
- Regulatory queries and investigations
- Team building and training
- Budgeting expertise
- Team Supervision
- Industry Expertise
Accomplishments
- Developed a simple and accurate GC method to determine actual nitrite content in excipients which are directly proportional to occurrence of nitrosamine impurities in finished product.
- Successfully filed 5 NCE-1, products till date.
- Addressed 42 regulatory deficiencies till date.
- Created spreadsheets and other forms of documentation in ELN and Empower to accurately record and calculate analytical results.
- Developed a data aggregation tool "DAART" along with IT team which acts as a ready reckoner for data compilation.
- Achieved resolution by introducing "ACD" software for critical separations of closely eluting peaks.
Timeline
Head of the Department, Analytical R&D
Novick BioSciences
12.2023 - Current
Analytical Expert
Dr. Reddy’s Laboratories
12.2018 - 09.2023
Analytical Expert
Dr. Reddys Laboratories
03.2016 - 12.2018
Analytical Expert
Dr. Reddy's Laboratories
11.2013 - 03.2016
Analytical Scientist
Dr. Reddy’s Laboratories
12.2008 - 11.2013
Associate Scientist
Lupin Research Park
09.2005 - 12.2008
M.Pharmacy - Pharmaceutical Analysis
Dr. MGR Medical University
Post Graduate Diploma in HR Management(PGDHRM) -
University of Pondicherry
B.Pharmacy -
Shri Vishnu College of Pharmacy
Six Sigma Green Belt -
American Society For Quality
Certified Scrum Master
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