Abhishek Singh, MS, RAC
Odessa,FL
Summary
With over 20 years in Pharmaceutical Industry, I've honed my expertise in regulatory environments, mastering FDA and EMA guidelines. My leadership in analytical research and quality control, combined with a knack for clear communication and cross-functional collaboration, has significantly contributed to streamlining regulatory submissions. My innovative approach and commitment to continuous learning have been pivotal in driving project success and regulatory compliance.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Manager, Analytical Research and Quality Control
Belcher Pharmaceuticals
01.2022 - Current
- Coordinates and supervise the development and validation of analytical methodologies for the characterization and control of Active Pharmaceutical Ingredients and drug products as per regulatory requirements with cGLP and cGMP compliance.
- Write and Review method validation protocols and reports.
- Clearly interpret problems, make scientific judgment based on outcome of the obtained data and take appropriate actions to resolve the issues.
- Improves analytical applications by implementing new analytical techniques to enhance maximum productivity.
- Compile necessary documentation to support regulatory submissions such as Abbreviated New Drug Applications (ANDAs) or New Drug Applications (NDA), as required.
- Monitor and communicate new regulatory requirements and review trends to affected functional areas such as R&D, Quality, and Operations.
- Respond to queries from FDA.
- Participate in the preparation of the requisite Labeling update, Annual Reports, PADERs (Periodic Adverse Drug Experience Reports) for approved drug products, and DSUR (Drug Safety Update Report) of drug products under clinical research.
- Coordinates with preparation and execution of stability protocols of finished drug products.
- Expertise in handling solid oral dosage forms, Liquid Oral dosage forms, Oral Suspensions, and Parentral Drug Products.
- Training people and upgrade their skill and knowledge base.
- Reviews protocols, reports, SOP’s, specifications & Test procedures.
- Assist with Pharmacovigilance and Product Complaints.
- Participate in development and execution of CMC regulatory strategies for product development and commercialization.
- Coordinates with review of CMC sections of regulatory submissions, including INDs, NDAs, and variations.
- Provide CMC regulatory guidance and support to cross-functional teams.
- Coordinated with regulatory submissions, variations, and post-approval changes
- Review and approve manufacturing and testing documentation.
- Participate in regulatory agency inspections and audits.
- Coordinates with activities such as equipment operation, calibration, maintenance and trouble shooting
- Guiding a team of 14 peoples involving Chemists, Sr. Chemists, and Supervisors.
- Managed and motivated employees to be productive and engaged in work.
- Accomplished multiple tasks within established timeframes.
Lab In-Charge
Belcher Pharmaceuticals LLC
01.2015 - 12.2021
- Coordinates and supervise the development and validation of analytical methodologies for the characterization and control of Active Pharmaceutical Ingredients and drug products as per regulatory requirements with cGLP and cGMP compliance.
- Troubleshot analytical issues, identifying root causes and implementing corrective actions.
- Development of various analytical method like assay, related substances, dissolution, elemental impurities etc.
- Clearly interpret problems, make scientific judgment based on outcome of the obtained data and take appropriate actions to resolve the issues.
- Improves analytical applications by implementing new analytical techniques to enhance maximum productivity.
- Troubleshot analytical issues, identifying root causes and implementing corrective actions.
- Enhanced laboratory efficiency with streamlined processes and optimized equipment utilization.
- Conducts experiment to address the response of deficiency letter from FDA.
- Maintained compliance with safety regulations, minimizing risk of accidents in the laboratory setting.
- Conducted thorough research and analysis to identify opportunities for process improvements and cost reductions.
- Writes protocols, reports, SOP’s, specifications & Test procedures.
- Coordinated with manufacturing personnel to transfer technology from lab-scale production to full-scale operations.
- Coordinates with activities such as equipment operation, calibration, maintenance and trouble shooting.
- Led safety training initiatives, educating staff on best practices for handling hazardous chemicals.
- Authored technical reports, effectively communicating key findings to stakeholders and clients.
- Analyze and interpret Laboratory data.
- Optimized data management systems for efficient storage and retrieval of experimental results.
- Guided a team of 12 peoples including Chemists, Sr Chemists, and Research Associates.
Sr. Chemist
Belcher Pharmaceuticals LLC
12.2008 - 12.2014
- Developed and validated chromatographic and titrimetric analysis methods.
- Conducting experiments in support to R&D for development and validation of process.
- Enhanced laboratory efficiency with streamlined processes and optimized equipment utilization.
- Performed techniques such as HPLC, UV/VIS, FTIR, XRD, ICP-MS, KF.
- Completed physical, qualitative and quantitative tests.
- Presented research findings at industry conferences, promoting company expertise and fostering professional relationships.
- Increased production capacity through scale-up efforts and equipment upgrades.
- Influenced product development by conducting comprehensive market research on emerging trends in the chemical industry.
- Contributed to intellectual property creation by co-authoring patent applications for novel chemical technologies.
- Ordered, calibrated, troubleshot and maintained laboratory equipment in good working order.
- Improved product quality by developing and optimizing chemical formulations for various applications.
- Prepared and reviewed documentation and SOPs.
- Developed new testing methodologies to ensure consistency and accuracy in analytical results.
- Established partnerships with external vendors for procurement of high-quality raw materials at competitive prices.
- Evaluated raw materials for suitability in product formulations, maintaining strict quality control standards.
- Coordinated and performed analytical tests to comply with established standards and specifications.
- Developed laboratory testing programs and data analysis while adhering to SOPs, STMs, Batch records and work instructions.
- Cleaned and organized laboratory and kept supplies well-stocked to save time, money and promote laboratory efficiency.
- Carried out laboratory tests and experiments to analyze, identify and isolate chemical compounds.
- Contributed to team discussions and new project initiatives to advance progress and optimize profitability.
- Performed standardized tests on organic and inorganic compounds to observe fundamental differences in properties.
- Modified and adapted standard methods and procedures to solve analytical problems.
Junior Manager
Dr Reddys Laboratories Ltd
06.2006 - 11.2008
- Prepare CMC sections of regulatory submissions of project from Dong-A pharmaceuticals.
- Worked in Regulatory Affairs department for CMC and other regulatory requirements of respective projects.
- Method development and method validation of New Chemical Entities and Active Pharmaceutical Ingredients.
- Independently handled the projects from customers such as GSK, Merck, Taiho, Novexel, Surface Logix, Schering Plough etc.
- Provided timely support to process R & D and Quality control in respective projects.
- Writing SOP's, Analytical report documents and Certificate of Analysis
- Coordinates with activities and troubleshooting in Wet analysis, Spectrophotometric Analysis and Thermal Analysis
- Conducted teleconference to communicate directly with project related issues with US, UK and Korean customers.
- Preparation and execution of stability protocols for analysis of API's.
- Helped team meet regulatory requirements by coordinating documentation and filings.
- Guided a team of 6 Research Associates and 2 Technical Trainees.
- Trained personnel in equipment maintenance and enforced participation in exercises focused on developing key skills.
- Resolved customer complaints swiftly and professionally, maintaining a high level of customer satisfaction.
Research Associate
Dr Reddy's Laboratories Ltd
06.2005 - 05.2006
- Set up equipment, organized inventory and maintained facilities.
- Provided technical guidance on experimental design and data interpretation issues for team members as needed.
- Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.
- Provided timely support to process R & D and Quality control in respective projects.
- Writing SOP's, Analytical report documents and Certificate of Analysis
- Coordinates with activities and troubleshooting in Wet analysis, Spectrophotometric Analysis and Thermal Analysis.
Technical Trainee
Dr Reddy's Laboratories Ltd
06.2004 - 05.2005
- Enhanced software proficiency by completing hands-on technical training and collaborating with experienced colleagues.
- Demonstrated commitment to continuous learning through self-guided study materials provided throughout the trainee program.
- Gained comprehensive understanding of relevant industry standards through attending workshops, seminars, and webinars.
- Provided timely support to process R&D in Wet Analysis, Spectrophotometric Analysis, and Thermal Analysis.
Education
Master of Science - Chemistry
Indian Institute of Technology
Roorkee, Uttarakhand01.2004
Bachelor of Science - Chemistry
Banaras Hindu University
Varanasi, Uttar Pradesh01.2002
Skills
- Ability to communicate clearly and honestly with peers, managers and customers
- Ability to work effectively in a cross-functional team environment
- Strong knowledge of regional regulatory requirements and guidelines, including FDA regulations, EMA regulations and ICH guidelines
- Understanding of global regulatory requirements and guidelines related to CMC
- Understanding of development and implementation of CMC regulatory strategies
- Ability to communicate clearly and honestly with peers, managers and customers
- Ability to work effectively in a cross-functional team environment
- Excellent communication and interpersonal skills
- Ability to assist in developing and executing regulatory strategies
- Excellent project management and organizational skills
- Ability to collaborate effectively with cross-functional teams
- Knowledge of regulatory submissions and documentation processes
- Strong analytical and problem-solving skills
- Proven track records of successful interactions with regulatory agencies
- Demonstrated ability to adapt changing regulatory landscapes and requirements
- Deep Observational and Analytical Behavior
- Innovative and Research Oriented
- Analysis of Biological Molecules
- Commitment to continuous learning, skill development
- Willingness to take calculated risks, without fear of consequences
Publications
- A Validated Chiral HPLC method for the determination of enantiomeric purity of R-b-amino-b-(4-methoxyphenyl) propionic acid, Chromatographia, 2007, 65, P. Madhavan, B. M. Rao, Pravin, Abhishek, P. R. Kumar, M. Sreenivasulu, K. B. Chandrasekhar
- A Rapid Stability-indicating LC method for Ziprasidone Hydrochloride, Chromatographia, 2007, 65, 191-196, A. Singh, B.M.Rao, G.R. Deshpande, S. Sangaraju, M.K. Srinivasu, M. Lalitha Devi, P. V. V. Satyanarayana, K. B. Chandrasekhar
- A Validated Chiral LC method for the Enantiomeric separation of b-Amino-b-(3-methoxyphenyl) propionic acid, Chromatographia, 2007, 66, P. Madhavan, B. M. Rao, B. Pravin, S. Abhishek, P. R. Kumar, M. Sreenivasulu, K. B. Chandrasekhar
- Stress degradation behaviour of Desipramine Hydrochloride and development of suitable stability-indicating LC method, Chromatographia, 2008, 68, Thilak Kumar Thiyagarajan, Mallikarjuna Rao B, Vukkum Pallavi, Jamal Abdul Naseer, Singh Abhishek, Deshpande Girish R
Accomplishments
- Isolation and characterization of an impurity up to 0.08% in Active Pharmaceutical Ingredients by using Preparative Chromatography leads to completion of one project in pre-defined timelines.
- Discrepancy during technology transfer in water content result of one of the Active Pharmaceutical Ingredient, at very low level, was solved by observing the lack of atmospheric moisture content factor in the software of one of the instrument.
- Development of chiral HPLC method for analysis of β-Amino acids leads to start up of amino acids project. The method was later treated as base for the publication of enantiomeric separation of few β-Amino acids in journal 'Chromatographia'.
- Development of rapid stability indicating HPLC method for one of the Active Pharmaceutical Ingredients 'Ziprasidone' leads to faster release of production batches. The method was later published in journal 'Chromatographia'.
- Thought of addition of Anti-oxidant in one of the compound, project from Tahio, leads to kick-start of one project.
- Achieved faster results with accuracy and efficiency by introducing analytical work sheets and validated excels.
Certification
- RAC-Drugs certified professional by RAPS Institute in April, 2024
Specialized Skills
Expertise in handling of instrumental techniques such as High Performance Liquid Chromatography (Waters, Agilent & Shimadzu), Ion-exchange Chromatography (Metrohm), UPLC/RRLC (Waters/Agilent), Differential Scanning Calorimetry (Shimadzu), Differential Thermal Analysis (Shimadzu), FT-IR Spectrometry(Perkin Elmer), Ultraviolet Spectrophotometry (Shimadzu & Jasco), Potentiometry (Mettler Toledo), LCMS (Agilent Triple Quad), Dissolution Apparatus (Distek), X-Ray Crystallography (Bruker), ICP-MS (Agilent), Strong Computer Skills (Windows, MS Office etc).
Languages
English
Full Professional
Hindi
Native or Bilingual
Timeline
Manager, Analytical Research and Quality Control
Belcher Pharmaceuticals
01.2022 - Current
Lab In-Charge
Belcher Pharmaceuticals LLC
01.2015 - 12.2021
Sr. Chemist
Belcher Pharmaceuticals LLC
12.2008 - 12.2014
Junior Manager
Dr Reddys Laboratories Ltd
06.2006 - 11.2008
Research Associate
Dr Reddy's Laboratories Ltd
06.2005 - 05.2006
Technical Trainee
Dr Reddy's Laboratories Ltd
06.2004 - 05.2005
Bachelor of Science - Chemistry
Banaras Hindu University
Master of Science - Chemistry
Indian Institute of Technology
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