Hi, I’m
MAHENDRA KUMAR NARLA
Abudhabi,United Arab Emirates
Summary
Experienced and resourceful Analytical development research scientist offering outstanding skills in method development, Technology transfer, method validation/verification and documentation for the product approval. Analytical specialist with about 13 years experience working with teams of scientists in research projects in GMP regulated environment. Extremely knowledgeable in written and oral communication skills to provide clear and concise information based on scientific research findings to team members and clients.
Overview
9
years of professional experience
7
years of post-secondary education
Work history
ADCAN pharma
Supervisor in Analytical department
2019.08
Job overview
- Investigated for literature and compendial sources to define an appropriate basis for analysis
- Reviewed various dossiers and prepare in-house technical documents like STM, Specifications
- Prepared and reviewed Analytical method transfer protocols and reports
- Reviewed methods of analysis, development reports, validation protocols and validation reports and ensure to be with highest quality and accuracy
- Interacted and collaborated with cross-functional team that includes operations, Quality control, Regulatory and Supply Chain
- Planned and organized laboratory personal on projects based on priorities, expertise and timelines
- Ordered laboratory reagents and accessories for the products testing and method validation
- Maintained the equipments in working conditions and arranged calibration when required
- Maintained analytical records and availability of chemicals and glassware and reference standards
- Investigated of Lab incidents, OOS, OOT and deviations through CAPA
- Provided support to regulatory department for any queries related to analytical aspect
- Provided Technical subject matter expert technical support to commercial testing, stability programs and manufacturing operations
- Identified deficiencies in skills among team, and work to improve individuals’ capabilities through coaching, development, and training. Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
- Wrote/revised SOPs, analytical methods, method validation / verification protocols/ Reports and Stability protocols/reports
- Used knowledge and practical application of materials sciences for solid and liquid dosage formulation characterization and scale-up projects
- Executed all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGLP and Company SOPs.
Julphar (Gulf Pharmaceutical Industries)
Officer in Product Development Laboratory
2014.10 - 2019.07 (4 education.years_Label & 9 education.months_Label)
Job overview
- Involved in development of various analytical methods for drug product like Assay, Dissolution and related substances
- Prepare and review of Analytical method transfer protocols and reports
- Invitro comparative dissolution profile studies
- Performed in process, finished product/release and stability testing of dosage forms as per the approved methods
- Performed drug-excipient compatability studies with support of formulation team
- Performed calibration of analytical equipment as per approved procedures
- Executed all functions in accordance with current FDA regulations, ICH guidelines, USP methodologies, cGLP and Company SOPs
- Documented all activities in the appropriate laboratory notebook as per SOPs and cGLP
- Assist in the general operation of the Analytical R&D laboratory, including maintenance of SOP's, training and equipment validation or maintenance
- Contributed to the development and/or implementation of new technology
- Review work from various sources, may assign work to others, and train less experienced employees.
Hetero labs limited
Junior officer in Analytical Development
2011.01 - 2014.10 (3 education.years_Label & 9 education.months_Label)
Job overview
- Performed routine and non-routine analysis on raw materials, drug substances, reference materials and drug products using a variety of instrumental and wet chemistry techniques
- Conducted method development activities as directed in a timely and efficient manner
- Documented development activities, and draft specifications and procedures as appropriate
- Prepared protocol and reports for validation as per guideline of regulatory markets and also for audit
- Operation and troubleshooting of sophisticated instrument in Lab
- Calibration of sophisticated Analytical Instruments like HPLC, Dissolution apparatus, UV-Visible spectrophotometer, pH meter etc
- Prepared Standard Operating Procedures for analytical laboratory under GLP guidelines
- Provided project support for analytical activities in method transfer, pre-formulation research or method validation, as needed.
Education
University College of pharmacy, KakinadaKakinada, Andhra Pradesh
Master of Pharmacy (Pharmaceutical Analysis & Quality Assurance)
2008.01 - 2010.04 (2 education.years_Label & 3 education.months_Label)
Hindu College of Pharmacy, GunturGuntur, Andhra Pradesh
Bachelor of Pharmacy
2003.01 - 2007.04 (4 education.years_Label & 3 education.months_Label)
Skills
- Data integrity and lab compliance
- Method development , validation and transfer
- GMP Documentation, Protocol and report writing
- Investigation and corrective action execution
- Handling of SAP
- Extensive organization and time management skills
- Project risk assessment and critical thinking
- Good documentation practices
- Skilled technical mentor
- Team leadership and collaboration
Languages
English & Telugu
Fluent
Hindi
Upper intermediate
Personal Information
- Date of birth: 06/20/1985
- Nationality: Indian
- Marital status: Married
Custom
I hereby declare that all the details furnished above are true to the best of my knowledge and belief.
Timeline
Supervisor in Analytical department
ADCAN pharma
2019.08
Officer in Product Development Laboratory
Julphar (Gulf Pharmaceutical Industries)
2014.10 - 2019.07 (4 education.years_Label & 9 education.months_Label)
Junior officer in Analytical Development
Hetero labs limited
2011.01 - 2014.10 (3 education.years_Label & 9 education.months_Label)
University College of pharmacy, Kakinada
Master of Pharmacy (Pharmaceutical Analysis & Quality Assurance)
2008.01 - 2010.04 (2 education.years_Label & 3 education.months_Label)
Hindu College of Pharmacy, Guntur
Bachelor of Pharmacy
2003.01 - 2007.04 (4 education.years_Label & 3 education.months_Label)