A versatile, enthusiastic and hardworking pharmaceutical science graduate with more than 7 years experience in research and manufacturing laboratory. With experience in analytical methodology for solid dosages, capsules, dry powder inhalations, parenterals and recombinant human insulin formulation. A committed team player with positive attribute towards diverse situations, I am looking for globally competitive environment that seeks ambitious and career conscious person. With proven ability to manage and complete projects to the highest standard, with a meticulous attention to detail and within agreed deadlines. I am ambitious and focused while appreciating the need to remain flexible and take responsibilities of everything. I do and overcome challenges through tenacious and questioning approach drawing on wide-ranging technical expertise. I thrive when working as a part of a cohesive team to deliver good results that yield multiple business benefits. Being proactive, adaptable and conscientious, I learn every day and work on constant self-betterment to achieve my goals.

AREAS OF EXPERTISE

1.Analytical techniques like HPLC, UV, dissolution processes etc

2.Biotechnology techniques like SDS Page, Urea Gel, ELISA

3.Routine calibration of equipments

4.Maintaince of reference standards and chemicals inventory

5.Adherence to GLP, GDP, STP’s and timely completion of lab activities

WORK EXPERIENCE

1) Organization : Syngene International Limited, Bangalore

Title : Senior Executive

Start / End Dates : November 2017 – June 2019

Roles and responsibilities :

Preparation of Reference Standards documents like Protocols, ODS, Reports, Familiarization, validation, Qualification, Evaluation and Characterization of reference standards and to ensure compliance with respect to BGRC and Baxter Quality requirements.

Execution of reference standard continued stability for use activities with respective of approved protocols and Qualification of reference standards and validation of reference test methods.

Calibration and maintenance of Equipment / instrument.

Responsible for online documentation adhering with GDP practice.

Execution of daily lab activities and maintain the lab as per CGMP standards.

Responsible of procurement of chemicals/reagents required for execution.

Responsible for handling of LIMS activities for Reference standard Qualification and CSU testing as per defined in the SOP.

To follow cGMP, GDP, GLP, and Regulatory compliance.

Responsible for initiation like change control, Incident, OOC, and OOS etc...

EHS training & compliance.

Attend mandatory trainings as and when conducted.

2) Organization : Gulf Pharmaceutical Industries, Ras Al Khaimah, UAE.

Title : Quality Control Analyst

Start / End Dates : March 2014 – November 2017

Roles and responsibilities :

Recombinant Human Insulin Crystals analysis as per USP and EP Specifications.

Generation of analytical reports and COA for insulin.

Demonstrate initiative to assure performance of routine QC responsibilities.

Wet chemistry analysis for the determination of concentration of buffers used in the production of Human Insulin.

Validation of all the process involved in the production of Human Insulin such as water and CIP

Successfully validated commercial batches of insulin by analyzing all the critical intermediates involved in the process including the final API and their stability.

Apply acceptable cGMP practices during execution of all work tasks.

Preparation of protocols and specifications with QA validation team to ensure proper flow of samples and corrective study in validation.

Competent in using HPLC, UV Spectrophotometer, ELISA, GC, AAS, TOC, Gel Electrophorosis and Kjeldahl to ensure the quality of In process samples and human Insulin API produced by recombinant DNA technology as per in house specifications, SOPs and GxPs.

Supervision of routine water analysis in the production facility and trending of reports.

Quantification analysis of Trypsin Recombinant enzyme assay and Carboxy Peptidase enzyme activity.

Stability study for Recombinant Human Insulin and impurity depletion study for in-process samples

RP HPLC column evaluation and stability study

Calibration of HPLC’s

Reviewing and updating SOPs with respect to company guidelines and CAPAs implemented.

Responsible for training new staffs according to SOPs and respective GLP and GMP.

Equipment troubleshooting and Laboratory incident investigations when required.

Use scientific expertise to provide assistance to co-workers for troubleshooting, laboratory investigations and problem resolution. Implementation of the system in QC laboratories with the help of system SOPs, Equipment SOPs, STMs, Specifications and Designing of Log books.

3) Organization : Dr. Reddy’s Laboratories, Hyderabad, India.

Title : Research Associate.

Start / End Dates : July 2013 - February 2014

Roles and responsibilities :

Collect the essential literature for API and drug product to develop robust and rugged analytical methods as per regulatory requirement.

Analysis of in-process and R&D stability samples in order to give continues support to formulation department.

Effectively perform assay and related wet chemistry analysis and responsible for stability data compilation (tablets, capsules and parentrals).

Responsible for maintenance and calibration of allotted instruments.

Follow the GLP and Lab safety as per company norms.

Evaluation of OOT’s and OOS’s at R&D raised by plant. Conduct the different experiments in order to resolve the critical analysis.

Online documentation of daily experiments

Prepare protocols for validation, ensure the availability of columns, impurities, samples and standards

Proficient at analytical techniques such as HPLC (Agilent and Waters), UV-spectrometer, Dissolution apparatus.

Adept at various operating software for daily work including CDS and Empower.

4) Organization: GlaxoSmithKline, Hertfordshire, United Kingdom.

Title: Analytical Scientist

Start/ End Dates: September 2011 - February 2013

Roles and responsibilities :

Assessing the aerodynamic distribution of particles by using NGI (Next Generation Impactors) and ACI (Anderson Cascade Impactors)

Determination of content uniformity of drug and carrying out experiment to find the novel emitted dose (nED)

Trained in automated systems like NGI Sample Recovery System (NSRS) and Next generation Dry Sample Introduction (NDSI)

Effectively perform assay and related wet chemistry analysis

To ensure all work are in compliance with GXP

Assisted in method development and performed method validation

Profiling of impurities

Accurately record, compiling and interpreting the data

Performed measure of statistical analysis for various method

Performed stability studies at different time points and trending of data

Assisted in the determination of root cause in laboratory investigations

Proficient at analytical techniques such as HPLC, twister HPLC, GC, UV

Periodic calibration of balances, PH meter and pipettes. Maintain inventory.

Adept at various operating software for daily work including CDS, EE and Statistica.

4) Organization : Ce-Chem Pharmaceutical Pvt Ltd, Bangalore, India.

Title : Industrial Trainee

Start / End Dates : December 2008

Roles and responsibilities :

To ensure all work is in compliance with GMP

Exposure to Tablet, Capsule production, coating techniques in detail

Handling of equipment calibration, reagent preparation and batch sheet processing

Assisting for testing and analysis of raw materials

Carry out Q.C tests like uniformity, disintegration, dissolution and friability tests on commercial dosage forms to ensure that they meet the necessary quality standards

TECHNICIAL SKILLS

Softwares like Empower, LIMS, SAP (beginner)

Computer knowledge (Ms-office, Excel, PowerPoint).

IELTS (International English Language Testing System)-With score of 7.5/9 from the British Council.

EDUCATION

Master’s Degree in Pharmaceutical Science from Kingston University, England,

United Kingdom. (2009 - 2011)

Bachelor’s Degree in Pharmacy from Al Ameen College of Pharmacy, Karnataka, India. (2004 - 2008)

Project and Presentations

Completed project on ‘Investigation of a novel nitrone cyclization and development towards the total synthesis of a potent natural product.

Albumin bound nanoparticles for anti-cancer therapy.

Prions.

JACOB MATHEW

Bangalore, Karnataka, India

Mobile : +917*********; Email : adg3k0@r.postjobfree.com

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