Expert Team Leader with 9 Year of Bio-analytical Experience
Resume:
Dr. ASHISH KUMAR SRIVASTAVA
Mobile: +91-900******* Email: *********@*****.**.**
Seeking Suitable Position in your esteemed organization.
SYNOPSIS:
M.I.C.A, Ph. D with 9 years of experience in Bio-analytical & Analytical research with reputed research companies.
Currently designated at Sun Pharmaceuticals limited, as Asst. Manager in Bio-analytical Department.
Adopt at Bio-analytical method development, validation, BA/BE study sample analysis and Project Management.
An enterprising leader with strong analytical, problem solving and interpersonal skills.
AUDIT EXPOSURE: US FDA, ANVISA, WHO, DCGI and SPONSOR AUDITS
JOB PROFILE AND RESPONSIBILITIES:
Review, correction, approval and submission of bio-analytical protocols, SOPs and final reports to Quality Assurance department.
Ensures Quality Control review of all bioanalytical projects conducted in bioanalytical department.
Interacts with Quality Assurance auditors on bioanalytical issues. May propose and implement new procedures relating to the above when appropriate.
Response to QA findings/audits related to bioanalytical raw data and final study reports.
Provides GLP training and assistance to new scientific and technical personnel working on bioanalytical projects about method SOP, protocol and project related technical documentation.
Works in close collaboration with Head-bioanalytical during the preparation and revision of Standard Operating Procedures (SOP) applicable to bioanalytical operations.
Training, reviewing and check of project related documentation that involves forms, training records and reports.
Ensuring compliance of various quality measures by maintaining requisite documentation/ records. Preparing daily & periodic laboratory reports for information, compliance & corrective action.
TECHNICAL RESPONSIBILITIES:
a) Bio-analytical method development, Method Validation, Subject sample analysis using LC-MS/MS (API2000, API3000, API3200, API4000 & Thermo Discovery MAX) and troubleshooting.
b) Development of high throughput sample extraction technique (Solid Phase Extraction, Liquid-Liquid Extraction, Acid Precipitation) for drug from Biological fluid.
c) Continuously look for ways to simplify and improve work processes to achieve better result, related to data analysis and report generation following strictly cGLP rules.
e) Maintain and prepare documents for Calibration (IQ, OQ, PQ documents) and Preventive Maintenance of Analytical Instrument’s as per Regulatory Requirement.
f) Preparation of Standard operating procedures, reports and protocols (Validation protocol, Bio-study protocol, Validation report and Bio-study report)
g) Proper utilization of manpower and resources to enhance productivity.
i) Design instrument and material requirement to be procure for bio-analytical activities and ensure qualification and compliance.
BIOANALYTICAL FACILITY SETUP:
Actively participated in bioanalytical facility setup at Reliance Life Sciences center & Accutest Research Laboratory, Navi Mumbai
PREVIOUS EXPERIENCE:
a) Development of Analytical methods for Drug substances and Drug product using High Performance Liquid Chromatography and Gas Chromatography.
b) Validation of analytical methods for drug substances and drug product using High Performance liquid Chromatography as per I.C.H guidelines.
c) Dissolution, Media development and routine analysis of different dosage forms (Tablet, Capsule and Injections).
d) Actively involved in carrying out the stability studies of the Drug Product as per I.C.H guidelines.
e) Calibration of components of Instruments HPLC, GC, UV-VIS Spectrophotometer and Infre-red Spectrophotometer.
f) Validation of the Organic Volatile Impurities and Residual Solvents using Gas Chromatography as per I.C.H guideline.
g) Chemical analysis of various pharmaceutical compounds using UV-VIS and Infrared spectroscopy.
ACHIVMENT:
a) Developed LC/MS/MS method of Alendronate sodium, Acomprosate, Simvastatin with Simvastatin acid and Artesunate with DHA etc.
b) Quantification of Erythropoietin in human serum using Automated BEP 2000 ELISA system.
c) Developed more than hundred analytical methods for the quantification of drug using LC/MS/MS.
d) Won so many prizes in Interdepartmental cricket tournament of Reliance life Science center and Dabur research foundation
ORGANIZATIONAL EXPERIENCE
Since May-2009
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Bio-Analytical Department
Asst. Manager
July-2006 to May09
DHIRUBHAI AMBANI LIFE SCIENCES CENTER
Bio-Analytical Department
Group Leader
Jan-2005 to July-2006
ACCUTEST RESEARCH LABORATORY
Bio-Analytical Department
Technical Manager
July-2002 to Sep-2004
DABUR RESEARCH FOUNDATION
Analytical Department
Research Scientist
Jan-2002 to June-2002
APL RESEARCH CENTRE
Analytical Department
Research Associate
EDUCATION
Ph.D in Chemistry under the title of “Application of HPLC method for the study of Anti-neoplastic drug products” from Buldelkhand University, Jhansi in 2011.
M. I.C.A (Master in Instrumentation & Commercial Methods of Industrial Analysis) from Jiwaji University, Gwalior in June-2001.
B. Sc. From Bundelkhand University, Jhansi 1998.
PUBLICATIONS
“Development of stability indicating HPLC method for the assay of Irinotecan in the presence of degradents” Journal of Analytical Chemistry” Volume 10, Issue 10, 2011by Trade Science Ich.
“Development of stability indicating HPLC method for the assay of Epirubicin in the presence of degradents” Journal of Analytical Chemistry” Volume 10, Issue 10, 2011by Trade Science Ich.
COMPUTER PROFICIENCY
Completed Certificate Course in Basic Software Operations.
Proficient in Microsoft Office Operating System (applications to include: Word, Power point Excel, etc.)
PERSONAL VITAE
Date of Birth : 2nd Aug, 1977
Marital Status : Married
Father’s Name : Sri Anand swaroop srivastava
Mother’s Name : Smt. M.D. Srivastava
Correspondence Address : Flat No. B-401, Mittal Tower, Sec-1, Koparkhariane
Navi Mumbai – 400709, India
Languages Known : English, Hindi
Dr. ASHISH KUMAR SRIVASTAVA
REFERENCES: On Request
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