Formulation chemist

SWARNA PAPPU

*** ******* *****, ***** **********, NJ, 07080

Email: ab04g3@r.postjobfree.com

Mobile: 201-***-****

OBJECTIVE

Obtain a challenging position in formulation and drug

product development that requires utilization of my technical and

collaborative skills to achieve business goals in a sustained manner.

SUMMARY

A Strategic pharmaceutical scientist with Seven years of in-depth

experience in preformulation and formulation development. Provides full

life cycle support for drug discovery ranging from NCE to late stage

clinical development.

CORE COMPETENCIES

. Formulation development of NCEs.

. Pre-formulation and drug discovery support

. Physical characterization of lead compounds and new chemical entities.

. Awareness of GMP and GLP.

. Experienced in working with CROs and CMOs.

. Great team player working within multidisciplinary teams

. Authored development reports.

. Problem solving skills

. Initiative taker and Innovative

. Manage multiple projects in parallel.

EDUCATION

Master of Science in Pharmaceutical Chemistry

Fairleigh Dickinson University, Madison, NJ.

May, 2007

Bachelor of Technology in Chemical Engineering

Jawaharlal Nehru Technological University, Hyderabad, India.

May, 2004

PROFESSIONAL EXPERIENCE

CONSULTANT AT MERCK RESEARCH LABS August 2012 to

present Chemist III, Basic pharmaceutical sciences group

. Involved in preparation of parenteral formulation of therapeutic

proteins and other large molecule compounds.

. Responsible for writing protocols and conducting accelerated

stability studies of therapeutic proteins, pH- stability profile

of proteins.

. Involved in chromatographic separation of proteins by using size

exclusion chromatography (SEC).

. Conducted particle size analysis by using digital light scattering

technique (DLS).

. Thoroughly involved in spray drying operations using a PROCEPT T

spray dryer to form amorphous solid dispersions for GLP studies.

. Conducted characterization of the spray dried dispersions using

XRPD, TGA, DSC, conducting slurry state solubility experiments

using UPLC and also conducting dissolution experiments.

. Conducted highly effective and rapid screening method for the

crystallization of peptides to identify ideal crystallization

conditions.

. Experienced in conducting forced degradation studies using LEAP

Technologies.

. Conducted photo stability studies to understand the degradation

pathways of API and related substances.

. Experienced in determining the Molar Absorptivity constant (MEC)

measurement using UV/visible, double beam spectrophotometer.

PTC THERAPEUTICS March 2007 to June 2012

Associate Scientist I (December 2010- June 2012)

Research Associate II (April 2008- December 2010)

Contract Research Associate II (March 2007- April 2008)

Drug discovery support:

. Developed suspension, solution and solid dosage forms for

preclinical and Phase I/IIa studies to assess in-vivo exposure of

water insoluble compounds for ADME and toxicological studies.

. Developed solubilized formulations for BCS II compounds

. Developed exposure-enhancing formulations for compounds with

limited absorption for delivery of drugs through IV, IM and IP

routes using co-solvents, lipids and combination of co-solvents

with surfactants and cyclodextrin based formulations for dosing in

animals.

. Determination of pH-solubility profile, solid state stability

under stress conditions, solution state stability.

. Developed a robust formulation approach using bead milling

technique to prepare homogenous aqueous suspensions to support pre-

clincal studies using New Chemical Entities (NCEs).

. Supported drug discovery groups by formulating drug in powdered

rodent chow and drug spiked liquid diet to support sustained

exposure in efficacy studies.

Formulation development for clinical studies:

. Identified a prototype amorphous spray dried tablet dosage form of

a water-insoluble candidate for preclinical and clinical

evaluation, demonstrated significant improvement in oral

bioavailability.

. Conducted experiments to optimize the spray drying process

parameters to understand the key steps to generate intermediate

spray dried dispersion.

. Responsible for writing stability protocols and conducting

chemical stability of the NCE's.

. Conducted DOE studies for developing a robust solid dosage

formulation.

. Worked with multiple CRO's and CMO's simultaneously for multiple

projects and was responsible for technology transfer of different

analytical methods.

. Reviewed manufacturing batch records (MBR) and monitored clinical

trial batch batch manufacture of drug product.

. Conducted in-use stability studies for evaluating suspension

formulation used in Phase IIa clinical studies.

. Conducted experiments to finalize the key parameters for roller

compaction to optimize the final identified formulation.

. Generated compression profiles on the Piccola tablet press

generated tablet hardness data, performed the flow ability, bulk

and tapped densities of the drug powder, to optimize the

formulation for compression process.

. Performed forced degradation studies on a NCE and elucidated

degradation pathway and products to gain an understanding of

chemical instability.

. Authored and issued several preformulation and formulation

development reports.

. .

Physical characterization:

. Conducted studies in solution and slurry state to identify the

most stable polymorphs of several compounds in development.

Characterized by DSC, microscopy and XRPD.

. Supported particle size effect studies in preclinical species for

evaluating BCS II and IV compounds.

Characterization of amorphous dispersions:

. Developed a robust solubility assay to assess the identified

formulation to understand the oral bioavailability in pre-clinical

species and evaluate the stability of the formulation.

. Conducted solubility studies to support spray drying trials.

. Supported excipient-compatibility studies using DSC and HPLC in

support of formulation development for clinical studies.

Dissolution Testing:

. Developed discriminating in-vitro dissolution media for new

chemical entities.

. Investigated the dissolution slow down observed for a lipid

formulation by studying formulation and capsule component factors.

. Conducted dissolution studies for routine stability testing.

Assisted in clinical supplies manufacturing planning (concurrent with

responsibilities above)

. Created spread sheets in Microsoft excel for all planned clinical

trials to keep a track of the quantities and dates for the API and

drug manufacturing, packaging and shipping and budgeting.

. Assisted in creating spreadsheets for patient kit allocation which

included the information on the patients registered for a

particular study, their dosages, dates of dosages, number of

sachets and kits required, current site inventory and the sachets

that need to be shipped on a timely basis.

SCHERING PLOUGH April

2006- October 2006

Contract Research Associate II, Oral and Respiratory Product

Development

Formulation:

. Involved in the solid formulation development of immediate release

and extended release tablets.

Process Technology:

. Performed the process technology operations like fluid bed

granulation, wet granulation using 5L KEY high shear granulator,

milling using Comil, blending using Turbula T2C mixer, and

compression using KEY 10 station tablet press.

Dissolution Testing:

. Developed a bio-relevant dissolution media and conducted

dissolution testing of tablets using Varian VK7010 automated

apparatus.

Drug property testing:

. Performed physical testing on solid dosage forms using KEY HT-500

tablet hardness tester, bulk density and tap density testing using

a Scott volumeter, particle size distribution, flowability using

Antech flotest tester and friability of tablets using Antech

FRV1000.

FAIRLEIGH DICKINSON UNIVERSITY

Teaching and Research Assistant September

2005- February 2006

. Preparation of reagents, supplies and standard solutions for

chemistry labs.

. Interpretation of data from NMR, FT-IR, MS, GC, HPLC.

. Keeping track of the inventory and overall maintenance of the lab.

. Tutored Organic Chemistry.

. Assisted undergraduate students with their assignments.

INDIAN INSTITUTE OF CHEMICAL TECHNOLOGY, Hyderabad, India

Research Associate

October 2003- October 2004

. Worked on a project, "Manufacture of Terepthalic Acid". Carried

out laboratory scale and pilot plant scale production of

Terepthalic Acid. Project constituted process design, process

optimization, and safety analysis and cost estimation.

SKILLS

. Thorough working knowledge of Procept T spray dryer, Powder X-ray

diffraction (XRPD), size exclusion chromatography, Digital light

scattering, Thermo gravimetric analysis (TGA), UPLC.

. Highly skilled in using Dissolution apparatus (USP Type I, II),

Waters HPLC-UV Systems (Mass Lynx and Empower softwares), Piccola

tablet press, blenders, Vectror TFC roller compactor and

granulator, dryers and size reduction mills, Metrohm Karl- Fisher

titratometer, pH & Conductivity meters, Thermo Nicolet IR

Spectrophotometer and JKEM reaction blocks apparatus.

. Highly skilled in solid state characterization of polymorphs and

amorphous materials with experiences for instrumentations such as

TA Instruments, differential scanning calorimetry (DSC), particle

size analysis by Axioscope 40A polarized light-microscopy, HCS 302

hot- stage microscopy.

. Experience with Word, Excel, Outlook or any other Microsoft Office

programs.

PROFESSIONAL MEMBERSHIPS

. Member of American Association of Pharmaceutical Scientists (AAPS).

. American Chemical Society (ACS).

. American Institute of Chemical Engineers, FDU Chapter.

COURSES AND SEMINARS

. Attended the seminar on Strategies for Bioavailability Enhancement

of Poorly Permeable APIs and Biologicals (BCS III & IV) by AAPS,

March 2010

. Practical Aspects of Amorphous Solid Dispersion Design and

Development by AAPS, NERDG conference April -2010

. Solubility behavior of salt and co crystal and formulation

considerations by AAPS, NERDG conference April -2010

. Attended the hands-on workshop hosted by Eudragit on hot-melt

technology, September-2010.

. Attended the seminar hosted by Gattefosse on "Enhancing the

solubility and bioavailability with lipid excipients and novel

approaches for sustained release formulations", May 2010.

. Attended the "Third Annual Dr.Charles I.Jarowski Industrial

Pharmacy symposium", held by St.John's University, NY and

understood the latest trends to formulate and develop poorly water

soluble compounds, May 2009.

. Attended the workshop held by Azopharma, "Optimized Post-Discovery

Compound Development (Screening and Selection Techniques to

Identify Successful New Drugs", July 2008 describing the Phase-1

proceedings in a drug development process.

. Attended the Lipid School by Gattefosse Corp., Newark, NJ, and January-

2008.

. Present at the Eastern Analytical Symposium (EAS), Somerset, NJ,

November-2006.

PRESENTATIONS

. Poster Presentations at Science day at PTC Therapeutics, September-

2008, 2009,2010, 2011

. Presentation at the AAPS, Northeast Regional Discussion Group

(NERDG) meeting on "Different Formulation Approaches to Support

Oral Dosing in Pre-clinical Studies in Drug Discovery", April-2011

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