POOJA CHANDOLA

Irving, Texas - *****

Email: acvpg9@r.postjobfree.com

Brief summary:

Pooja has more than10 years of experience in the Bio-technology and Bio-pharmaceuticals industry after having worked in the areas of Quality Control and vaccine production.

She is well acquainted with all biochemical techniques such as ELISA, purity determination and final product concentration by HPLC, bioactivity of Tissue plasminogen activator, Western blotting etc. and have done method verification of some of these processes. She also has exposure in making test specifications, Standard Operating Procedures and in operation SAP related activities.

Pooja has experience in laboratory scale production of Pertussis and Tetanus vaccine along with animal testing of vaccines like tetanus, pertussis etc. She is a seasoned quality control professional who excels in identifying and improving Quality, saving time and cost of analysis by thorough resource utilization management

Work Experience:

Organization

SYNGENE INTERNATIONAL, a Biocon subsidiary, Bangalore India

Duration

March 2013 - March 2015

Role

Assistant Manager - Quality Control

Responsibilities

Managed a team in the quality control department which handled 'Large Molecules' related projects for national and International clients. Performed quality analysis of In-process, semi-finished and finished products as per GMP norms.

Involved in preparation of protocol and summary reports for stability studies, method verification and method transfers.

Prepared worksheets for batch release, stability studies, verification and method transfer

Was involved in Instrument operating procedures, standard operating procedures and Equipment operating procedures.

Reviewed periodic calibration reports of all analytical instruments located in Quality Control department.

Raised change controls with respect to products and equipment’s and resolved any deviations to standards by remedial action and training.

Analyzed and reviewed Quality control reports for batch release.

Organization

GENNOVA BIOPHARMACEUTICALS LIMITED, Pune, India

Duration

November 2008 - October 2012

Role

Senior Executive -Quality Control

Responsibilities

Tissue plasminogen activator (abbreviated tPA) is a protein involved in the breakdown of blood clots. It is a serine protease) found on endothelial cells, the cells that line the blood vessels. As an enzyme, it catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown. Because it works on the clotting system, tPA is used in clinical medicine to treat embolic or thrombotic stroke. Use is contraindicated in haemorrhagic stroke and head trauma.

Managed a 6 member team which was responsible for Tissue plasminogen activator (TNK-TPA).

Was involved in document review related to regular In process, Semi finish, Final bulk and Finish product analysis of TNK-tPA (As per in-house protocol).

Handled QA related queries and technical analysis of problems occurring on day to day basis.

Was involved in preparation and execution of protocols, analysis and reports of Process validation and cleaning validation samples of TNK-TPA.

Prepared Stability protocols, Stability calendar, monitoring their timely withdrawals, reconciliation sheet and their analysis within time, document review related to Stability sample analysis, Stability short reports, Stability reports for three consecutive batches and their trend analysis.

Was also involved in preparation and execution of internal standard protocols, analysis and reports of TNK-TPA.

Made Specifications and worksheets of In-process, Semi finish and Finish product, SOPs and their periodic review.

SAP related activities like making Specifications and editing whenever changes made in the respected specifications, Result loading and releasing of materials, etc.

Was fully involved in the Validation of Bioactivity by clot lysis method for TNK-TPA.

Organization

PANACEA BIOTEC LIMITED, Chandigarh India

Duration

October 2004 to July 2006

Role

Scientific Officer

Responsibilities

Lab scale production of Tetanus toxoid and Pertussis vaccine.

Preparation of Mueller and Miller medium for tetanus production and B-2 medium for Pertussis production.

Preparation of other media’s like Heart Infusion glucose broth, Fluid thioglycollate medium, Soyabean casein digest medium, Bordet Gengou agar base.

Determination of Lf/ml of tetanus toxin, filtration of toxin, detoxification, ultrafiltration of toxoid and salt precipitation.

Testing of toxin and toxoid – MTV & MLD test.

Potency testing of Diphtheria, Tetanus and Pertussis in a vaccine.

Adsorption test of tetanus and diphtheria component in vaccines.

Abnormal toxicity test of vaccines.

Specific toxicity test of Diphtheria and Tetanus.

Specific toxicity test of Pertussis by mouse weight gain test.

Potency testing of Diphtheria, Tetanus and Pertussis by active challenge method.

Immunogenecity of Hib vaccine.

Formulation of individual component and combination vaccines.

Preparation of aluminium phosphate gel used in vaccine formulation.

Serology test involving Bridging studies carried out with Chiron.

Elisa of Diphtheria, Tetanus, Pertussis, Hepatitis and Hib.

Organization

PANACEA BIOTEC LIMITED, Quality Assurance and R & D, New Delhi

Duration

May 2002 to October 2004

Role

Scientific Officer

Responsibilities

Preparation of Standard Operating Procedures.

Handling complaints, vendor approval, lot release and other activities of Q.A.

Distribution and archiving of documents.

Conducting audits and training.

Serology test involving Bridging studies carried out with Chiron.

ELISA of Diphtheria, Tetanus, Pertussis, Hepatitis and Hib.

Educational Profile:

Master of Science in Biomedical Technology (2004) from Hemwati Nanadan Bahuguna Garhwal University, Srinagar, Uttranchal. India

Bachelor of Science in Microbiology (2000) from Kurukshetra University, Yamunanagar, Haryana, India

Special Training:

Undergone 6 weeks training at Central Drugs Laboratory (C.R.I., Kasauli) on ‘Quality Control of Vaccines and Sera’.

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