Development Manufacturing

Ranjit S. Sarpal. Ph.D. *

CONFIDENTIAL

Ranjit S. Sarpal

**** ******* *****, ***********, ** 19335

Phone: 610-***-**** (Home). Email: *******@*******.***

Highlights of Qualifications

Ph.D., 34 publications in refereed journals, a patent and several presentations in

industry/conferences.

Over 15 years of R & D, manufacturing and tech transfer experience in academia,

biotech and pharmaceutical industry in directing, supervising and executing

protein/peptide/vaccine/small molecules formulations and dosage form development,

lyophilization, liposomes, emulsions, and other colloid based nanocarriers, analytical and

chromatographic techniques, spectroscopy, photochemistry, bio-physical and

environmental chemistry.

Developed analytical methods using analytical separations techniques, lyophilization,

lipid extrusion, calorimetry, light scattering, centrifugation, UV/VIS, fluorescence and

various other spectroscopy techniques

Acted as a liaison between industry and academia, directed several projects,

multitasking, supervised laboratory staff, completed many management trainings,

established drug delivery labs. Received several fellowships, excellent writing,

communication and computer skills, team player, focussed career oriented, motivated.

INDUSTRIAL EXPERIENCE

Merck & Co.: March, 2003 Onwards

Working in the sterile biologics technology transfer group of Merck Manufacturing Division

in West Point, PA. Primary responsibilities include partnering with multifunctional teams

(Capital, Regulatory, R&D, Operations, Validation etc.) to provide technical support

ranging from rudimentary media preparation to more advanced lyophilization unit

operations to build a new biologic manufacturing facility in North Carolina. Lead the

Performance Qualification (PQ) efforts for sterile process unit operations in the new facility.

Implement 6 and lean manufacturing tools on the equipment and processes. Develop,

modify and transfer manufacturing processes to the Merck manufacturing facilities.

Managing people, projects, partnering with many cross functional teams.

Wyeth: October, 2000 to March, 2003

Worked in Wyeth Vaccine R & D division. Primary responsibilities included formulation

and process development, characterization, scale up and technology transfer of liquid and

lyophilized protein conjugated bacterial and viral subunit vaccines, peptides; Led several

projects across multifunctional teams; Lyophilization cycle development and improvement

of biologics. Additionally, the job functions included supervise, plan, support, lead,

coordinate and execute day to day laboratory activities, scientific research and report writing

to support regulatory filing.

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Ranjit S. Sarpal. Ph.D. 2

CONFIDENTIAL

Aronex Pharmaceuticals: September 1999 to October 2000

Worked in Aronex Pharmaceuticals that is focussed on the development of anticancer and

antifungal (Terpenes, Platinum analoques, Anthracyclenes, small molecules) lyophilized

drug products for human clinical trials. Joined as a team member and later headed

formulation development group. Primary responsibilities included the development and

characterization of anticancer and antifungal products under clinical trials, plan, support,

supervise, coordinate and execute day to day laboratory activities, scientific research, write

reports for NDA filing. Carried out key experiment to respond to FDA questions on Drug

filed application to FDA.

Formatech, Inc.: July, 1998 to September, 1999

Worked in Formatech, Inc. a drug development company specialist in the formulation and

process development of small molecules, proteins and peptides. Primary responsibilities

were initiating, directing and executing all areas of scientific research and development

strategies, supervise and train laboratory staff. Formulated and developed lyophilized

dosage forms of peptide and proteins. Designed controlled release systems for sub-

cutaneous injection route of a peptide. Developed novel liposomal drug delivery systems for

efficient loading and release of drug. Advised project supervisors on many scientific issues.

Access Pharmaceuticals and Duke University Collaboration: July, 1996 to July, 1998

Worked in collaboration with Duke University and Access Pharmaceuticals a drug

delivery system design specialist in Dallas, TX. This collaboration involved several months

of industrial training, visits to industrial site, project updates, technology development and

transfer, patent licensing rights to Access Pharmaceuticals. Developed a lipid based unique

drug delivery system in which micelles are efficiently entrapped inside the liposomes. This

nanocarrier proved suitable for efficient loading and stability of an anticancer drug Taxol.

This novel drug carrier system now under testing for several other anticancer and drugs.

PATENT & FIVE KEY PUBLICATIONS

Patent: David Needham and Ranjit Sarpal Liposomes containing active agents . Number:

6,143,321 and US 6,296,870 B1

1. D. Needham and R.S. Sarpal (1998). Binding of paclitaxel to lipid interfaces:

Correlations with interfacial compliance. J. Liposome Research. 8, 147.

2. S. Nigam, R.S. Sarpal, M. Belletete and G. Durocher (1996). 3H-Indoles in CTAB

micelles and water: Spectroscopy and Photophysics at various temperatures. J. Colloid

Int. Sci. 177, 143.

3. R.S. Sarpal and S.K. Dogra (1995). The association parameters of bromide and iodide

ions with cationic micelles using steady state fluorescence quenching measurements. J.

Photochem. Photobiol. A: 88, 147.

4. R.S. Sarpal, M. Belletete and G. Durocher (1994). Effect of small chemical variation

and functionality on the solubilization behavior and recognition capability of 3H-indoles

in SDS and CTAB. Chem. Phy. Let. 221, 1.

5. R.S. Sarpal and G. Durocher (1994). Temperature induced structural and permeability

changes in DODAB vesicles: A fluorescence investigation using 2-[(p-

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Ranjit S. Sarpal. Ph.D. 3

CONFIDENTIAL

methylamino)phenyl]-3,3-dimethyl-5-carboethoxy-3H-indole as a probe. J. Photochem.

Photobiol. A: 80, 307.

RESEARCH & PROFESSIONAL EXPERIENCE

Mar 2003 Onwards Sr. Process Engineer/Manager, Merck Manufacturing Division

(Technology Transfer Group), West Point, PA

Oct., 2000-Mar 2003 Senior Scientist, Wyeth-Vaccines, R & D (Formulation and

Process Development), Pearl River, NY

Sept., 1999 Oct., 2000 Research Scientist (Product Development), Aronex

Pharmaceuticals, The Woodlands, TX

July, 1998 Sept., 1999 Staff Scientist (Product Development), Formatech, Inc. Lowell,

MA.

July, 1996 July, 1998 Research Associate, Department of Mechanical Engineering

and Materials Science, Duke University, Durham, NC with

Prof. David Needham (In collaboration with Access

Pharmaceuticals, Dallas, TX).

May, 1994 July, 1996 Staff Scientist, Department of Chemistry, Washington State

University, Pullman, WA, with Prof. Kenneth Mopper.

Feb. 1992 May, 1994 Postdoctoral Fellow, Department of Chemistry, University of

Montreal, Montreal, Quebec, Canada, with Prof. Gilles

Durocher.

Jan., 1986 Jan., 1992 Graduate Student and Project Scientist, Department of

Chemistry, Indian Institute of Technology, Kanpur, with Prof.

Sneh K. Dogra.

EDUCATION

Ph.D., Indian Institute of Technology, Kanpur, India 1991 (Biophysical Chemistry).

M.Sc. (Hons.), Guru Nanak Dev University, Amritsar, India 1985 (Chemistry).

Ph.D. THESIS

An electronic spectral study of some substituted aromatic molecules in aqueous and micellar

media. Department of Chemistry, Indian Institute of Technology, Kanpur, India (1991).

RELATED ACCOMPLISHMENTS & SKILLS

Completed project management training at North Eastern University; underwent extensive

management training program, 6 and lean manufacturing training program at Merck &

CO., Established microcarrier engineering research laboratory in Duke comprehensive

cancer center and at Formatech. Established state of the art photochemistry laboratory in

Indian Institute of Technology, India. Drafted several scientific proposals, managed research

funds, and prepared scientific reports. Supervised and trained graduate/undergraduate

students and company scientific staff. Participated in a scientific expedition to Antarctica to

study the effect of ozone depletion on marine biota.

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