V. Bala Venkatesh
Scientist-B3 In Analytical R&D
Kothapeta,AP
Summary
Dynamic and results-driven Scientist with over [Number] years of experience in the [Industry] industry. Proven expertise in [Skill] and [Skill], complemented by a strong analytical mindset and a commitment to driving innovative solutions. Adept at collaborating with cross-functional teams to achieve project goals and enhance operational efficiency. Passionate about leveraging scientific knowledge to contribute to advancements in the field and deliver impactful results.
Overview
10
10
years of professional experience
Work History
Scientist-B3, Analytical Department
Analys Lab Private limited
2020.07 - Current
- Expert in developing and validating/Verifying test methods for pharmaceutical raw materials and finished products for strength, impurities, identity using HPLC and LCMS (for nitrosamines and NDSRI's)
- An expert at testing pharmaceutical raw materials and finished products by internally developed and compendial test methods
- Skilled in troubleshooting analytical and instrument problems and at performing OOS investigations
- Well-versed in GMPs as they pertain to an R&D analytical group and pharmaceutical product development
- Manage Manage and oversee the stability program for all of development projects, applying statistical analysis to interpret analytical and stability data. Serve as the primary point of contact for stability software and the Laboratory Information Management System (LIMS)
- Experienced in writing SOP's laboratory investigations, out-of-specification and deviation reports, CAPA's, change controls.
- Author and/or review the development, qualification, validation and transfer of documents
- A working knowledge of pharmaceutical formulations development
- Oversee analytical strategy, planning and execution for overall product development pipeline
- Drive the methods validation strategy and timeline working closely with cross-functional and external partners
Senior Chemist, Analytical Department
Shilpa Medicare Private Limited
2017.03 - 2020.07
- Hands on experience on analytical technologies such as HPLC and LCMS
- Significant experience with method development and validation for Raw materials, intermediates and finished products
- Direct experiences on transfer of analytical methods to CMO's is required
- Extensive experiences on authoring analytical sections for regulatory submissions
- Leadership experience with proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
- Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements
Chemist, Analytical Department
Arene Life Sciences
2015.08 - 2017.03
- Represent Analytical Development on program teams
- Develop approaches to negotiation with regulatory agencies of analytical control strategies including specifications and stability for the entire supply chain: from regulatory starting materials to bulk drug substance
- Establish and manage reference standards and reference materials
- Manage, develop, and hire, as appropriate, a team of Analytical Development scientists
- Author technical reports and protocols
- Provide input and data for regulatory submissions, including writing and reviewing Module to analytical content
Education
M.Sc - Organic Chemistry
S.K.B.R College
Amalapuram01.2015
B.Sc - Chemistry
Sathabdi Degree College
Kothapeta01.2013
M.P.C
Aditya junior college
Amalapuram01.2009
Skills
Strong communication skills and diplomacy are required for this leadership position
Proven success leading analytical development function: strategy, task assignments and monitoring progress, building a network of external partners
Deep experience leading an Analytical Development function with GMP responsibilities
BSc, MSc with 10 years of experience relating to pharmaceutical development and validation
Experience working with clients and internal project teams is required
CMC and regulatory experience with advancing drug product formulations through later stage clinical trials encouraged
Design and oversee the development, validation and transfer of phase appropriate analytical methods for raw materials, in-process control, drug product and drug substances strategy
Act as a mentor for the junior staff and emphasize best practices
Partner with QA and Regulatory to support batch releases and regulatory submissions
Of time: Execution of experimental studies
Provide analytical oversight of external vendors for Generic API and finished dose CMC analytical activities for small molecule drug substance (DS) and drug product (DP)
Select and manage providers of analytical services, including analytical services embedded in contract manufacturing organizations (CMOs)
Research and experiments
Laboratory techniques
Hypothesis testing
Quantitative skills
Assay development
Lab experiments and research
Critical thinking
Experiment protocol development
Excellent communication
Research methods
Experimental design
Analytical skills
Research coordination
Chromatography
Timeline
Scientist-B3, Analytical Department
Analys Lab Private limited
2020.07 - Current
Senior Chemist, Analytical Department
Shilpa Medicare Private Limited
2017.03 - 2020.07
Chemist, Analytical Department
Arene Life Sciences
2015.08 - 2017.03
B.Sc - Chemistry
Sathabdi Degree College
M.P.C
Aditya junior college
M.Sc - Organic Chemistry
S.K.B.R College