Project Manager Process

PANKAJ DALAL, Ph.D

***, ******* ****, */*, Gaithersburg, MD 20878, USA

(Home): 240-***-**** E.Mail: abhvrr@r.postjobfree.com

PROFILE

A team player that responds well to Business dynamics, ability in

identifying areas of need and priority, extract the essentials and

establish innovative ways to perform multiple tasks toward the achievement

of departmental objectives.

. Proven leadership and teamwork skills.

. Extensive experience in upstream process development using fedbatch and

continuous production processes.

. Extensive experience in handling computerized fermentors/ disposable

bioreactors such as cult bag system

. Perform validation or process improvement studies, scale up of

processes and investigations, author protocols and development reports

and coordinate/design required experiments.

. Extensive computer knowledge, experience in statistical design of

experiments.

. Extensive understanding of cGMP, GLP and ICH guidelines for

manufacturing of therapeutic proteins.

PROFESSIONAL EXPERIENCE

ADVANCED BIOSCIENCE LABORATORIES INC, KENSINGTON, MD, USA (NOVEMBER 2005-

Present)

Working with contract manufacturing organization, handled several process

development projects for therapeutic proteins for phase I/II clinical

trials. The clients includes Cambridge Antibody Technology, US

Pharmacoepia, Novodigm, University of Alabama and DMID

. Led the team of scientists, manufacturing Manager, QA/QC Manager and

project Manager for development of E.coli/yeast and mammalian cell

based recombinant protein production processes.

. Transferred technology for fermentation and purification of

recombinant products from client organization.

. Prepared process development plan for production, purification and

characterization of recombinant proteins.

. Provided consumable costing and labor estimate for the process

development effort of a project.

. Developed scale down model of fermentation processes to optimize the

specific productivity of the recombinant proteins. Increased the

specific productivity by at least 100 fold in fed batch culture.

. Developed and optimized midstream harvesting processes using dead end

filtration, tangential flow filtration and batch centrifugation.

. Delivered high cell density fermentation processes for expression of

recombinant proteins in E.coli and yeast system in fully instrumented

fermentors.

. Interacted with clients, process development, manufacturing, project

management and QA/QC group to ensure that client- specific process

would fall within capabilities of the manufacturing group and facility.

. Held weekly team meetings to discuss project progress.

. Ordered all raw materials for process development, manufacturing

pilot and cGMP production runs.

. Worked closely with technology vendors such as Millipore Corporation,

Pall Corporation, Sartorius and New Brunswick Scientific Company.

Responsible for identification and acquisition of latest technology.

. Scaled-up PD developed process for manufacturing and trouble-shoot

scale-up issues.

. Created client specific technical transfer documents and batch

records compliant with cGMP manufacturing.

. Evaluated success of each production run and created a run summary,

which included process history, performance and process improvement

suggestions.

. Defined process hold time, batch size and in process stability of

recombinant protein products using PAT approach.

. Qualified analytical methods such as SE-HPLC, SDS-PAGE, Protein

estimation by UV spectroscopy method and ELISA for linearity, range,

accuracy, precision (repeatability and intermediate precision) limit of

detection, limit of quantitation and robustness using ICH guidelines.

. Created client specific technical transfer documents, Progress

reports and final fermentation summary report.

. Contributed for the process development of Chemical, manufacturing

and control section of the IND applications.

. Wrote and reviewed SOPs, material specifications, bill of testing and

BPRs for manufacturing operation.

. Trained-manufacturing technicians on PD developed fermentation

processes so that it can be reproduced in cGMP manufacturing area.

. Worked closely with QC/QA manager for investigation on OOS and

deviation during manufacturing.

Internal Research Projects

.Optimized cell culture process for very high-level expression of

recombinant immunotoxin and recombinant plant GNA lectin molecules by high

cell density E.coli culture. Expression level of 2.5 g/L of rGNA was

achieved using E.coli high cell density culture.

.Optimized mammalian cell culture such as CHO and Hut78 cell lines for

expression of recombinant proteins in cultibag system

.Optimized purification process for recombinant plant GNA lectin from

inclusion bodies using tangential flow filtration, Ion exchange

chromatography and Hydrophobic interaction chromatography.

. Cloned and expressed virus like particles (Hepatitis B surface antigen

gene) in yeast Pichia pastoris.

.Wrote research proposals for cloning and expression of HIV epitopes on

virus like particles.

.Prepared research proposals for US government/NIH research contract.

VIVENTIA BIOTECHNOLOGY, WINNIPEG, CANADA (2004-2005)

Project

PROCESS DEVELOPMENT FOR IMMUNOTOXIN MOLECULES AS CANCER THERAPEUTICS

.Prepared research plan for optimization of cell culture for very high

level secretion of recombinant immunotoxin molecules by E.coli under

control of pBAD promoter on minimal medium components using statistical

multifactorial design of experiments. The factors considered for

optimization are temperature for growth and expression, pH, inducer

(Arabinose) concentration, medium components such as glycerol concentration

and ammonium sulfate concentration, specific growth rate and dissolve

oxygen concentration.

.Optimized high cell density culture (HCDC) of genetically engineered

E.coli for over production of recombinant immunotoxins molecules. Improved

production of secreted multimeric immunotoxin molecules using HCDC of

E.coli by at least 100 fold. Saved $ 1600/batch by optimization of the

inducer concentration for production of recombinant immunotoxin molecules.

.Successfully scaled up HCDC process from 15-liter capacity to 150 liter

capacity fermentors in cGMP area.

.Developed cost effective purification processes for five different

recombinant immunotoxin (monoclonal Fab fragments connected with Toxic

protein pay load by recombinant DNA technology containing His tag)

molecules using combination of tangential flow filtration, Cation Exchange

Chromatography, Immobilized metal ion affinity chromatography, gel

filtration chromatography and anion exchange chromatography.

.Developed and optimized tangential flow microfiltration process for

harvesting the cells and clarification of the fermentation broth from the

fermentor.

.Interacted with vendors to maintain equipment and ordered supplies.

.Prepared schedule for manufacturing and assigned shifts duty to the

technician.

.Prepared sterile drug product for clinical trial studies on time.

DSM BIOLOGICS, MONTREAL (2003) Contract Manufacturing

Projects

MANUFACTURE OF RECOMBINANT PLASMINOGEN FOR PHASE II CLINICAL TRIAL (BRITISH

BIOTECHNOLOGY)

.Transferred purification technology from client organization to R&D

division of DSM Biologics.

.Established Scale down model of recombinant Plasminogen purification in

R&D laboratory to have hands on experience with purification process. The

unit operations involved in purification process are solvent detergent

treatment for viral inactivation, Affinity chromatography using lysine

Sepharose, NFP tangential flow filtration to remove viruses, hydrophobic

interaction chromatography using Octyl Sepharose, hydroxyapatite

chromatography and Buffer exchange using Sephadex G-50 column.

.Worked in team environment with cell culture group, Analytical

Biochemistry group and with clients for technology transfer.

.Prepared and reviewed manufacturing protocols for transfer of purification

technology from R&D lab in to cGMP area within DSM Biologics.

.Coordinated project team meetings consisting of Client, Project manager,

supervisors from cell culture, Production, QC and QA.

.Developed Process Flow Diagrams, capacity models, and COGs models using

SuperProdesigner software. Calculated the column configuration and amount

of chromatographic resins required, membrane filtration area and amount of

buffer required for purification of recombinant Plasminogen from 750 L cell

culture supernatant.

.Reviewed bill of material, Production protocols and bill of testing in

team consisting of production supervisor (Downstream), QA and QC

representatives and material management group.

.Supervised junior staff and their training on production.

.Prepared deviation report when ever there was a deviation in the process

and impact on the process was accessed scientifically.

.Prepared investigation report by collecting all the facts when ever there

was a lower yield then expected in cGMP area.

.Scaled up purification process in cGMP area to recover purified

recombinant plasminogen ( ~35-40 g/batch)for Phase II clinical trials.

.Prepared formulated sterile bulk recombinant plasminogen for

lyophilization.

.Prepared manufacturing report after five consecutive successful cGMP

batches.

BIOTECHNOLOGY RESEARCH CENTER, REBUS CORPORATION (MAY 2001-MARCH 2002)

XANTHAN GUM PROCESS DEVELOPMENT

.Developed fermentation process for Food grade biopolymer (Xanthan

Polysaccharide) production in shake flasks up to 20 litre fermentor (New

Brunswick Bioflow 3000, Chemap) using batch and fed batch technique.

.Developed process for production of Xanthan gum on wheat starch

hydrolyzate and characterized the xanthan gum as per Chemical Codex

guidelines.

.Prepared SOPs and Batch evaluation data sheet.

.Organized information and generated reports.

DEPARTMENT OF BIOTECHNOLOGY, CADILA PHARMACEUTICALS LTD. (JULY 1989-

JULY2000)

RECOMBINANT HEPATITIS B VACCINE

.The gene for the Hepatitis B Surface antigen (HBsAg) was cloned from

chromosomal DNA of Indian isolate of Hepatitis B virus and characterized in

Escherichia coli.

.The Hepatitis B surface antigen gene was sub cloned in to 2 micron plasmid

of yeast Saccharomyces cerevisiae under the control of PHO5 promoter for

expression. The intracellular expression of 23 kD protein Hepatitis B

surface antigen was confirmed by western blot. ABBOTT conformational ELISA

kit (AUSAB) revealed the presence of virus like particle form of Hepatitis

B surface antigen in cell homogenates.

.High cell density fed batch fermentation process was developed (20L

capacity CHEMAP fermentors) for high level expression of Hepatitis B

Surface antigen in yeast Saccharomyces cerevisiae.

EDUCATION

December 1985-89: Ph.D, Microbiology. University of Paris XI, Orsay,

Paris, France.

November 1984-85: M.Phil, Microbiology,

University of Paris XI, Orsay, Paris, France.

RESEARCH GRANT SUPPORT AND AWARDS

1984-1988: Ministere des Affaires Etrangeres, France "Genetics and

Biochemistry of cellulose degradation".

Total award 192,000 FF

1995-2000 Department of Science and Technology, Technology Development

board, India "Development of Recombinant Hepatitis B vaccine" Total award

$ 1,000,000.

COMPUTER PROFICIENCY

.Trained on Documentum software for effective data management in biotech

manufacturing environment.

.Trained on SuperProdesigner. SuperPro Designer is a tool for engineers

and scientists in process development, process engineering, and

manufacturing that facilitates modeling, evaluation and optimization of

integrated processes. It includes an extensive chemical component and

mixture database and extensive equipment and resource databases.

.Trained on MODDE statistical software for design of experiments based on

multi factorial design of experiments to screen, optimize and to study

robustness of the process and analytical procedures.

.Hands on experience with CloneManager software for protein and DNA

sequence analysis, restriction analysis and primer synthesis.

.Used extensively Empower software (Waters) for HPLC analysis of Proteins.

.Operates business software such as MSAccess, MSExcel, MSPowerPoint.

.Possesses hands on experience with Unicorn Protein Purification Software

(Pharmacia) for programming AKTA Explorer, Biopilot and Bioprocess system.

.Adept at extracting business/science/debugging information effectively

through the use of web based applications such as Google and MEDLINESEARCH.

TRAINING

1. "Good Laboratory Practices" Montgomery College, Rockville, MD on 30

July, 2007.

2.Workshop on " Mammalian Cell culrure and Scale up" at Penn State

University, State College, Pennsylvania between September 12 and September

19, 2005.

3.Management Training at DSM Biologics on Working through conflict and

adapting to change, Personal Empowerment and Partnerships for Improvements,

Managing you Priorities and delegation for productivity and growth. By

Marie-Catherine Ladure. of Development Dimensions International.

4.Design, Validation and regulatory compliance of Pharmaceutical processes

and facilities. Continuous Education Program, Dept. Applied Science and

Technology, University of Toronto, January 28-29, 2001. Course Co-

ordinators Mr. Alan Kwong, PharmEng Tech and Mr.Jack Basarke, Therapeutic

Products Program, Health Canada.

5.Senior Management Program on "Team building and Conflict Management"

conducted by Dr.Uma Jain May 13-14, 1996.

6.Eucaryotic Expression Vector System - Biology and Applications.

International Conference organized by National Institute of Immunology and

International center for Genetic Engineering and Biotechnology, New Delhi,

India, 1996

7.International workshop on "Down stream processing in Biotechnology"

Indian Institute of Technology, New Delhi, India, 1992.

8.International Conference on " Down stream Processing in Biotechnology"

Dept. Biotechnology, Anna University, Madras, 1989.

9. International Biotechnology Symposium, Paris, France, 1988.

10.International conference on "Genetics and Biochemistry of Cellulose

degradation" Institut Pasteur, Paris France 1986,

11.Indo-French workshop on "Genetic engineering and Technology of Yeast"

Indian Institute of Technology, New Delhi, India, 1983.

PUBLICATIONS

1.Cloning and high level expression of Galanthus nivalis lectin in high

cell density culture of E.coli culture and its facile purification.

Submitted to Protein Expression and Purification

2.Physiological and Kinetic studies on cellulase enzyme production by

Trichoderma reesei CL-847 during continuous culture growth. Doctorate

thesis submitted to Paris University XI, Orsay, France, 1989.

3. Cellulase enzyme production by Trichoderma reesei CL-847 in continuous

membrane assisted cell recycling system. Presented at 8th international

Biotechnology symposium, Palais de Congress, Paris, France 1988.

4. Heterogeneity of secreted cellulases of Trichoderma reesei CL-847 during

continuous culture growth. Presented at International conference on

"Genetics and Biochemistry of Cellulose degradation" Institut Pasteur,

Paris, France, 1986.

5. Studies on the contamination of feed molasses for continuous ethanol

production by immobilized yeast cell reactor

J. Chem. Technology and Biotechnology 10: 244-250, 1984.

6. Studies on Cellulase enzyme production by Penicillium funiculosum mutant

UV 49 Presented at 7th International Biotechnology Symposium, New Delhi,

1984.

REFERENCES

Available on request

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