Engineer Process

OBJECTIVE

Seeking a challenging position to bridge lab and land as

Engineer/Scientist.

SUMMARY OF QUALIFICATIONS

Experienced with formulation, process development, process fit to

plan, technology transfer,process validation and fill finish process

support of biologics parenteral formulation, topical and trans-dermal

drug delivery emulsions.

Experienced with solid dosage formulations through couple of summer

internship at contract manufacturing facility.

Performed DoE to substantiate formulation robustness for Drug Product

and analyzed its results (response surface) using JMP and Design

Expert software. This was later compiled formulation robustness

report.

Ability to integrate two or more support studies into a single

integrated experiment.

De-risked the effect of 316 L stainless steel leachable by designing

and completing a spiking study in two week.

Designed and executed experiments to support CCIT, Scale down model

hold study, silicone and other excipient spiking studies.

Worked on Quality by Design (QbD) by identifying CQA and CPP and

performed stability studies on the identified CPPs.

Inherited new technologies, peptides and surfactants to make robust

formulations.

Worked through FDA regulations in evaluating stability issues to

deliver the product before deadline.

Coordinated with CRO, and external labs to perform various stability

studies and analytical testing to deliver a project in a timely

manner.

Experience in working as a team and consistently finish assigned work

ahead of schedule.

Excellent communication, software and troubleshooting skills.

Working on to get certified with Green belt in DFSS (DMADV) with a

project to improve documentation process.

EDUCATION

Illinois Institute of Technology, Chicago, IL

August 2007 - May 2009

M.S. Biological Engineering

Anna University, India August 2003 -

May 2007

B.Tech. Industrial Biotechnology

TECHNICAL SKILLS

Industrial Techniques Process scale Up, Process development and Process

optimization.

Lab Techniques HPLC, UPLC, MFI, Sub-Vis particle analysis by light

obscuration, ELISA,DLS,DSC, SDS-PAGE, Absorbance by A350,

SEC-UPLC.

High throughput formulation screening by Hamilton Robotic

system

Software & Languages Matlab, JMP, Design Expert,Empower 2, Minitab, MS Office

Used

EXPERIENCE

Janssen,Pharmaceutical Companies of Johnson &Johnson

July2012- present

Associate Scientist

Experienced in formulation support by designing and performing

experiments for manufacturing light assessment studies, metal spiking,

silicone spiking and silicone migration studies, CCIT, formulation

robustness and boundary studies.

Participated in various process development studies by following

Quality by Design (QbD) in identifying CQA and CPPs.

Worked with Q.A, Supply chain and manufacturing teams in finalizing

process validation protocol, coordinated engineering and process

validation batches.

Experienced in authoring and reviewing technology transfer protocol,

technology transfer report, process validation protocol, process

validation report.

Introduced new template for technology transfer report and master

process validation plan.

Designed and performed a scale down fill finish study to simulate the

stress and process impact on the formulations. Integrated scale down

fill finish study and manufacturing light assessment study as a same

experiment.

Introduced LEAN approach in performing MFI testing, thus increasing

output to 6 samples from 4 samples per day.

Performed pharmacy manual and saline bag compatibility studies to

study the particle formations, bioavailability and compatibility of

the DP in infusion kits.

Assisted manufacturing plant by testing samples from filter

validation, filter clog studies, Piston pump and rotary vane pump

filling studies.

Developed Light Chain-Heavy Chain detection method on UPLC and used

the same to apply in early look platform approach in screening

formulations.

Initiated a culture change to document and review experiments in a

timely fashion on electronic lab notebook.

Contributed to BLA filing by authoring sections on formulation

development and process validation.

Coordinated with CROs on some project out sourcing initiatives for

high concentration formulation stability studies.

Working on a novel drug delivery system to administer oncology

formulation through sub-cutaneous administration.

HNC Products, Inc. February

2010- July2012.

Research & Q.C-Q.A Engineer

Formulated and scaled up about thirty two topical and trans-dermal

formulations based on client's requirement.

Studied the use of phospholipids as nitrogen carriers in transdermal

application for dilating the arteries.

Performed process development, process optimization, and tech transfer

to production plant.

Analyzed the efficacy of lecithin organogels over

phosphatidylcholine as active drug carriers for API like Alpha-lipoic

acid, retinol, salicylic acid and ascorbic acid on emulsion systems to

enhance sustained drug delivery mechanism.

Incorporated many peptides and poly peptides in transdermal

formulation.

Developed and validated HPLC testing methods for API, vitamins and

peptides to check its efficacy in formulations and in turn used these

data for Continuous Process Improvement.

Prepared documentations and SOPs for new equipment and processes to

implement cGMP.

Modified existing compounding procedure to reduce the heat shocks on

thermo liable drugs like acyl glutathione and vitamins.

Changed W/O emulsion compounding process to W/O/W to accommodate 15 %

Ascorbyl palmitate.

Coordinated with process chemist in the absence of process engineer in

making batches.

IIT-Online Technical Services, Chicago, IL

January 2008- May 2009

Student- Supervisor

Assessed quality control in video editing from Internet media

developers.

Trained 28 students with new software tools used on video editing.

Simplified the video editing, reducing the cycle time from 2 hours to

40 minutes.

Scheduling work for student in accordance to their availability.

Malladi Drugs and Pharmaceuticals Pvt Ltd, India

Project Trainee

December 2006-April 2007

Process Development and Scale-up -Citric Acid Fermentation

The project aimed to ferment citric acid from commercially viable

media using wild strain of A.niger.

Process economics was considered to replace glucose broth with cane

molasses media.

Upstream processing was done to mimic cane molasses media as glucose

broth.

INTERNSHIPS

Sai Mirra Innopharm Pvt Ltd,India (Contract manufactures for Dr.

Reddy's Laboratories, Inc.)

Intern-Granulation and Production Summer

2006

. Got trained on granulation and capsulation process under USP and EP

standards for solid dosage formulation.

. Worked on granulator, blender, fluidized bed drier, capsulation and

tablet packing machines.

. Trained in validation engineering like cleaning, equipment validation

and CIP.

Sai Mirra Innopharm Pvt Ltd,India

Intern- Microbiology and Quality Control Summer

2005

. Onsite microbial count in the granulation and capsulation units.

. Bacterial and fungal contamination tests for tablets and capsules.

PROJECTS

Univariate Stastical analysis in gas separation using vortex tube

separator.

. Determined variation of temperature with respect to time and

correlated using Minitab.

. Statistical tools like I-MR and EWMA Chart was applied to prove that

instrument is reliable.

CFD approach for bubble pattern in a fluidized bed reactor.

. Simulated the Bubbles and Flow regime Computation with respect to

density variation for a vertical column.

. A CFD simulation was carried out using FORTRAN.

Business Plan Primer for Bioprocessed drinks manufacturing.

. Worked in a team on balance sheets, cash flow statements and marketing

methodologies.

. Plant commissioning features were studied for most economical plant

designing.

Effect of aeration rate on production of carotenoids using isolated yeast

of Rhodotorula glutinis.

. Optimized the production media on shake flask.

. Studied growth pattern of yeast Rhodotorula glutinis on petri plates

and culture broth.

. Conducted upstream processing of media as the carbon source needed to

be diluted to 50% (w/w).

TECHNICAL SOCIETY MEMPERSHIP:- American association of pharmaceutical

scientist.

TRAINING PROGRAMS-

Innovation in formulations at SCC midyear meeting (June-2011).

Scale up and processing cosmetic formulations(May-2012)

Lean early development approach (jan-2013).

FPX-Flawless Project Execution (Sep-2014)

Advanced Empower training at Waters Corporation (Nov-2014)

Design of Experiments by JMP.

AWARD

Deans Fellowship- Armour College of Engineering-IIT Chicago

August 2007-May 2008

Several ENCORE (internal recognition award in J&J).

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