From,

Prashantha R.B

INM Technologies,

#*, *.*.********** ******,

12th K.M, Mysore Road,

Bangalore-560059

Karnataka.

To,

VP/ Head,

Human Resoures Department/F R&D

Respected sir,

Sub: - Application for a suitable position at your esteemed organization.

I (Mr. Prashantha R.B) would like to present myself to work in your esteemed organization in light of my qualification and experience.

I have completed Master of Pharmacy in Pharmaceutical Analysis and working in Analytical Research Development of INM Technologies, Bangalore forRegulated markets. I have the ability to work as a team member with a firm belief on Together Everyone Achieves More (TEAM), I firmly believe, that I for the position you are seeking to fill.

In order to apprise you of my detailed academics and experience, I am here by enclosing recent curriculum vitae to your kind perusal.

If given an opportunity to serve in your organization, I will prove myself with best of my abilities and hope to win your faith very soon.

Note:Am applying for this oversees opportunity in your esteemed organization in view of my H1B petition being approved and currently am H1B visa Holder (Till 2020).

Thanking you sir.

Yours sincerely

Prashantha R.B

RESUME

PRASHANTHA R.B.

C/o Neerajakshulu.

No. 107, 1st floor, Lakshmivenkateshwara Nilaya

3rd main BSK 3rd stage Anjaneya nagar

Ittamadu main road

Bangalore - 560068.

Karnataka [India].

Mobile: +91-897*******

E Mail: ac7k6i@r.postjobfree.com.

CAREER OBJECTIVE:

To pursue career in Analytical research in an organization which provides a challenging work environment and allows me to grow both professionally and as an individual.

AREAS OF EXPERTISE:

ANDA FILING NEEDS

LAB ESTABLISHMENT

PROBLEM SOLVING

FIRST-TO-FILE FOCUS

AGENCY QUERY RESPONSE

FACING AUDITS

METHOD DEVELOPMENT & VALIDATION

CRITICAL INVESTIGATIONS

STRATEGIC PLANNING

RLD REVERSE ENGINERING

TECHNICAL WRITING

DECISION MAKING

cGLP & QbD IMPLEMENTATION

SETTING SPECIFICATIONS

CMO DEALINGS

COMPATIBILITY STUDIES

QUALITY CONTROL

QMS IMPLEMENTATION

STABILITY STUDY DESIGN & EVALUATION

POTENT & COMPLEX FORMULATIONS

SUPERVISION

TECHNOLOGY TRANSFER

PROFESSIONAL EXPERIENCE:

Have an about 9.0 years experience in Formulation AR&D.

Company

Duration

Post Held

INM Technologies, Bangalore.(Shilpa medicare company)

From Apr-17to Till date

Manager

Biocon Limited, Bangalore.

From July-15 to Apr-17

Principal Scientist

Biocon Limited, Bangalore.

Apr-13 to June-15

Senior Scientist

Micro Advance research centre (MARC)

Micro labs Limited, Bangalore.

June-2011 to March 2013

Research Associate

Micro Advance research centre (MARC) Micro labs Limited, Bangalore.

May 2010 to May 2011

Trainee Research Associate

Job profile in INM Technologies working as a manager

.

Positioned in a leading role to oversee complete analytical support for complex novel drug product developments for Global market especially US, EU and Canada markets.

Development of robust analytical methods, Validations and Reverse engineering studies for pilot batches of complex novel drug products like Injectable Liposomes, Ophthalmic emulsion, Ophthalmic suspension, topical dosage formulations, transdermal dosage forms within a stringent timeline for non-clinical PK, toxicity studies and First-in-human exploratory formulations.

Possess insightful knowledge of RLD and reference product characterization, QbD experimental designs, troubleshooting instruments, method development, validation, bound and unbound drug assessment in drug product, in vitro drug release studies, specification setting, and stability testing following a quality management and compliance system.

Well-versed with software like Empower, Chromeleon, Infionic

An effective communicator with exceptional relationship management, a mentor, a trainer, and team worker with hands-on experience in networking with project partners, cross functional team, customers and allied agencies

Job profile in Biocon Limited working as a principle scientist

Positioned in a leading role, to oversee complete analytical support for product developments targeted for US, EU and Canada markets, especially for potent formulations.

Analytical Method development, Validations and Transfers and Reverse engineering studies.

QbD based analytical method optimizations and drawn a design space.

Successfully completed analytical services for several FTF (First-to-File) projects.

Lab setting-up, Quality and Compliance system design and implementation.

Effectively monitoring outsourced activities - CMOs & CROs coordination task management.

Evaluation of stability data generated for Submission batches.

Training, guiding, motivating and mentoring team to enable most efficient delivery.

Strategic discussions for timely dossier compilations.

Efficiently working on critical evaluation & preparation of documents for dossier filing in US &

Europe.

Design and review of protocols, Specifications, Technical reports, SOPs, Lab reports, Guidelines etc

Resource planning and organization of tasks for effective utilization & timeline management.

Job profile in Biocon Limited worked as Senior scientist

Analytical method development for the tests like related substances, Assay, Dissolution, Residue, Residual solvents by HPLC, GC and UPLC.

Analytical Method Validation of Assay, Related substances, dissolution, residual solvents and residue for Tablets, Capsules.

Preparation of Method development report, Validation protocols and Method validation reports.

Analytical method transfers to the Quality Control Departments.

Review the Validation protocol and the method validation reports.

Troubleshooting analytical related Queries.

Preparation of Specification and standard test procedures for drug product.

HPLC analysis for the Stress, Stability and in process samples (Formulations).

Reverse Engineering development activities for the estimation of Excipients.

Calibration of instruments HPLC, CAD&GC.

Job profile in Micro Labs limited

Preparation of Literature search reports for new products under development.

Analytical method development of Assay, Preservative content, Related substances and viscosity for

Ophthalmic solutions and Solid orals as per regulatory requirements.

Preparation of analytical method development protocols and reports.

Stability study analysis for ophthalmic and solid oral formulations as per ICH guidelines.

Analytical Method transfer and Method verifications from R & D to plant QC.

Preparation of analytical method transfer and method verification Protocols.

Preparation of Stability study data compilations for the R&D scale batches

Preparation of standard Test methods for product analysis.

Calibration of analytical instruments like HPLC and IC.

Preparation and Maintenance of working standards.

Review of finished product specifications (In-process, Release and shelf life)

Theoretical knowledge of analytical method validation work.

Applying QBD elements for new analytical method development product.

Preparation of method development report and test procedure.

Reverse Engineering development activities for the estimation of Excipients.

PROFESSIONAL ACHIEVEMENTS:

Executed mehtod development, validation and tranfer to site for an project and filed

product to US with in time.

Actively involved in setting up an analytical lab right from scratch, preparation and implementation

of SOPs and involved in various activities of R&D.

Actively involved In the DCGI Audit preparation of New R&D facility of Biocon.

Actively participated in setting up of the ANDA lab and preparation of relevant documents like IOP

and EOP’s for the instruments and equipments.

Key Team player in Qualifying of all the instruments.

Worked as a key team member of Analytical Department for the USFDA Audit at Sterile Production

Facility of Micro Labs.

INSTRUMENTS HANDLED:

UPLC, HPLC & GC.

Particle size Analyzer.

Ultra CAD.

XRD.

Dissolution apparatus-(USP-I,II & III)

Ion chromatograph.

IR Spectrometer.

KF Auto tirator.

Osmometer

Viscometer (Rheolac)

EDUCATIONAL QUALIFICATION:

Examination passed

Board/University

% Marks

Master of pharmacy

National college of pharmacy Shimoga

Rajiv Gandhi university Bangalore

72.71

Bachelor of pharmacy

Bapuji pharmacy college Davanagere

Rajiv Gandhi university Bangalore

60.5

Area of Interest

Analytical - Research and Development

Strengths

1.Analytical approach, hard working, confident and adjusting nature, A willingness to continue learning,

2.A strong sense of professional responsibility,

3.The ability to lead a team to success.

4.Participating in various activities

Extra Curricular Activities

Attended National seminar on “Recent Development in PharmaceuticalAnalysis” held at PES College

of Pharmacy, Bangalore

Attended seminar on Scope and Potential after pharmacy held at Bapuji college of Pharmacy,Davanagere.

Hobbies and Interests

Participating in social activities

Reading & Traveling

Computer knowledge

Well versed with the computer Fundamentals like- Windows, Ms-office, Internet Browsing, etc.

PERSONAL DETAILS:

Father’s Name: Mr. R.T.Basavaraja

Permanent address: Thimmappaiahnahally (Post)

Challakere-(Tk), Chitradurga-(Dt)

Date of Birth:22-07-1983

Nationality:Indian

Religion:Hindu

Sex: Male

Marital status: Married.

Languages Known: English,Kannada,Hindi& Telugu

DECLARATION:

I hereby declare that the above mentioned particulars are true to the best of my knowledge and belief. I am sure that I’ll make big positive impact on your business with my skills and best performance, if opportunity is given in your esteemed organization.

Place: Bangalore Sincerely,

Date: 26-10-2018 Prashantha R B

Contact this candidate