Asha Resume

Ashalatha Venkatachalapathi

312-***-**** (Mobile)

952-***-**** (Home)

Email: *******@*****.***

Professional Summary:

* + years of diverse experience in Microbiology. As a Lead Microbiologist, With Masters degree in Microbiology and Post graduate diploma in Genetics and Immunology worked for various prestigious Organizations in cGMP environment. During my tenure, I developed and validated microbiological test methods and stability studies using advanced technologies. Implemented HACCP program and updated Quality programs.

Conduct internal audits and involved in external audits done by FDA, USDA.

Educational Qualification:

Master of Science (M. Sc) in MICROBIOLOGY, Oxford College of Science, Bangalore University, India. (2000 – 2002)

Bachelor of Science (B. Sc) in MICROBIOLOGY, CHEMISTRY, and ZOOLOGY, Mount Carmel College, Bangalore University, India. (1997 – 2000)

PROFESSIONAL EXPERIENCE:

ENIVA Corporation, Blaine, MN (2006 – Current)

Job Description & Responsibilities:

• As project leader, Leading a team of Microbiologists and training staff. My expertise is put to practice in Quality Control, Food Safety, GMP's, plant personnel training on Personal Hygiene, Cross Contamination, HACCP, MSDS, Microbiology testing, sampling, developing test procedures using USP Methods, specification development for finished products and Raw materials, preparing the plant for Customer and agencies audits.

• Develop and update applicable standard operating procedures (SOP).

• Provide assistance with complaint/out of specification (OOS) investigation process.

• Conduct housekeeping audits and prepare the technical reports as necessary.

• Comply with GMP, HACCP, and other quality and safety requirements.

• Work with QA/Micro team to generate CAPA.

• Identify Micro-organisms by microscopic examination of physiological, morphological, and cultural characteristics.

• Media preparation and Sterilization.

• Develop and validate protocols for cleaning and sanitizing procedures of production equipment, by using ATP Charm Analyzer. Perform environmental monitoring studies.

• Promote safety, good laboratory practices and housekeeping in accordance with GLP and company’s internal policies and procedures.

• Perform Stability Studies on Finished Products.

Medical Research Services, Frankfurt, Germany (2004 – 2005)

Job Description & Responsibilities:

• Undertook literature searches to be used for medical expert reports.

• Set up reference lists in Excel and to transform them into Word documents for Clinical and Preclinical Overviews and Summaries.

• Compile files to be submitted to Health Authorities.

• Support in data analysis and compilation of reports to be submitted to the regulatory authorities.

• Generate appropriate documentation, including protocols, logs, folders, etc.

LOTUS Labs Pvt. Ltd. Bangalore, India (CRO-Owned By Actavis Pharma, Iceland) (2002 – 2004)

Job Description & Responsibilities:

• As Research Associate in Bio-analytical laboratory Responsible for the analysis of drugs in biological samples in conformance to GLP guidelines:

• Develop & validate the methods of drugs in biological fluids using HPLC, LC/MS/MS.

• Process and analyze biological samples for drug/metabolite concentrations for bio studies using HPLC, LC/MS/MS. Used LCMS/MS API 2000, 3000, 4000.

• Media preparation

• ETO and Steam Sterilization.

• Prepare and revise SOPs and Active participation during internal and external audits.

• Responsible for development and validation of various methods of extraction for various pharmaceutical compounds using LC-MS/MS, HPLC, in human plasma for bioequivalence and bioavailability studies.

• Validation of bio-analytical methods using HPLC and LCMS/MS

• Training of analysts and other technical staffs, new recruits

• Co-ordinate projects in conformance to various regulatory agencies like USFDA, WHO.

• To prepare general and bio analytical method SOPs.

• Calibration of testing equipments like HPLC,LCMS/MS, analytical balance, pH meter, Evaporators and Centrifuges, Micropipettes

• To review Bio-analytical raw data, to ensure validity and accuracy.

• Conduct internal audits and faced external audits done by WHO,USFDA

• Communicate efficiently and able to teach others.

EXPERTISE:

Technical:

Sterility testing Sample preparation, Method development & Validation

PCR Electrophoresis, SDS-PAGE, Immunoassay

LCMS/MS, HPLC Cell Culture, Media preparation, Sterilization (Steam, ETO)

ELISA Microbial Identification- SPC, E. coli, S. aureus, Salmonella, Listeria, Yeast and mold.

Blotting Techniques Molecular Cloning and Expression

Regulatory Compliance:

• Preparation of SOPs

• Supervision of laboratory instruments IQ, OQ, PQ & calibration reports.

• Monitor Documentation and archiving

• Design of logbooks and monitoring of log book entries

• Conduct internal audits

• Training of personnel

• Safety compliance.

• Generate Corrective and Preventive Action (CAPA).

• HACCP program.

Certification and Professional Training:

• Course in “Basic Techniques in Molecular Biology and Immunology”, at Mount Carmel College, Bangalore, India.

• Project “Studies on the Expression of Transforming Growth Factor (TGF) 3 in the Female Reproductive Tissues of Golden Hamsters” from the Department of Molecular Reproduction, Development and Genetics, in the Indian Institute of Science (IISc), Bangalore, India.

• Project, titled “Cloning and Expression of the Cytoplasmic Domain of Non - Structural Protein, NSP4 from Rotavirus Strains SA11 and I321” from the Department of Microbiology and Cell biology, in the Indian Institute of Science (IISc), Bangalore, India.

• Honors Program in “Genetics”, at St. Josephs College, Bangalore, India.

• LC-MS/MS operation conducted by LABINDIA at lotus labs.

Seminars Attended:

• The Jacob-Monod model of gene control for the lac Operon.

• Distribution and Occurrence of the Normal Flora in Skin, Eye, Respiratory Tract, Mouth, Gastrointestinal Tract, urinary Tract.

• Biological Transformation of Nitrogen and Nitrogen Compounds - The Nitrogen Cycle.

• The Major Histocompatibility complex (MHC) and its significance in immunity.

Computer Knowledge:

Hands on experience in using Windows XP and Vista, Microsoft Office Products (Microsoft Word, Excel, Power Point etc,) WordPerfect, UNIX and Visual basics.

Reference: Will be furnished upon request.

Contact this candidate