Process Manufacturing

Shital Patil

*** ***** ***** ****

Bridgewater, NJ 08807

Contact no.: 908-***-****

******.*******@*****.***

Summary

Two years of work experience in the biopharmaceutical industry. Strong technical

background in the manufacturing of monoclonal antibodies, therapeutic proteins, microbial

fermentation and cGMP operations. Unique experience set in both validation and sterile

manufacturing processes. Skilled in troubleshooting, root cause analysis and writing

process validation protocols.

Education

M.S. Pharmaceutical Manufacturing, Stevens Institute of Technology, Dec. 13.

GPA: 3.735/4.00

B. Tech. Bioinformatics, Dr. D. Y. Patil Biotechnology & Bioinformatics Institute, June 08

graduated in first division with distinction

Courses Taken:

Introduction to project management, Validation and regulatory affairs, Good manufacturing

practices in pharmaceutical facility design, Lean six sigma in pharmaceutical

manufacturing, Quality in pharmaceutical manufacturing, Contemporary concepts in

pharmaceutical validation.

Work Experience

Validation Engineer, Stevens Institute of Technology, Hoboken, New Jersey Aug.12 to Dec

12.

• Hands on experience of preparing Validation Master Plan, Validation Protocols,

Validation Reports. Optimization of various process parameters using statistical

tools like Design of Experiment, Process Capability, Gage R&R using Minitab 16.

• Developed process flow diagrams and spreadsheet validation protocol.

• To determine critical process parameters created fish bone diagram and FMEA for

each step of process. Performed CAPA and root cause analysis to validate systems.

• Responsible for generation and execution of IQ, OQ and PQ protocols for

manufacturing equipment at lab scale and process validation protocols including

deviation history.

• Knowledge about 4 phases of quality system, risk based analysis, Quality by Design

(QbD) approach.

• Prepared and Maintained Logbook according to GMP standards.

Jr. Executive, Production Development Lab, SciGen BioPharma Pvt. Ltd., Pune, India.

Aug. 08 to March 10

• Part of team performing Upstream Processing of Insulin batches. Worked on

• Insulin media preparation, shake flask culture, fermenter preparation,

fermenter inoculation, cell harvesting, homogenization, cell concentration

and tangential flow filtration (TFF).

• In detail knowledge of Fermenter Sterilization (ESIP, FSIP & CIP), CIP of

Tangential Flow Filtration and Homogenizer.

• Generated IQ, OQ and PQ protocols for autoclave. Performed heat

distribution studies of empty and loaded autoclave. Done heat penetration

studies depending on cold spot.

• Carried out microbial fermentation studies from bench scale to pilot scale.

• Filter integrity testing (bubble point test).

• Planning of routine experimental batches for Insulin and GCSF.

• Preparation of SOP for instrument operation, cleaning, and calibration.

• Design qualification and installation qualification review for Insulin main

plant.

• Co-ordination with various cross functional teams.

• Preparation, updating and reviewing of SOP's, BMR and other process related

documents.

Trainee, BioZeen, Biotech labs, Bangalore, India. Feb. 08 to May 08

• The training covered different modules such as animal cell culture, downstream

processing, fermentation, sterilization & filtration and bioprocess engineering.

This gave me an opportunity to draw Piping and Instrumentation diagrams

(P&ID) of fermenter, media preparation vessel, heat exchanger, media preparation

vessel and CIP skid. I also learned Cleaning- In- Place (CIP), Sterilization- In- Place

(ESIP & FSIP), autoclave design and control.

Intern, Lupin Pharmaceuticals, Aurangabad, India June to July 07

• Learnt about the different steps of making tablets which included dispensing, powder

blending, granulation, tablet compression, and packaging.

Academic Projects

-Developed a process for tablet manufacturing using Design of Experiment based on

Quality by Design. Stevens Institute of Technology, Aug.to Dec. 12

• Used Lean Six Sigma tools such as Process Mapping, Time Value Map, Value Stream

Mapping, Time Series Plot, Gage Linearity and Bias, Gage R&R, Process Capability,

Statistical Process Control using Minitab 16.

• Created Fish Bone (Ishikawa diagram) and Risk Assessment (FMEA) for each step of

process to determine Critical Control Parameters to get quality product.

• Using FMEA developed Validation Master Plan and Equipment Qualification (IQ, OQ,

PQ) and process validation protocols.

• During cleaning validation studies performed root cause analysis, suggested

corrective action and preventive action (CAPA).

• Created SOP’s, Protocols and project documents.

• Wrote a term paper that describes facility for manufacturing of insulin of batch size

50L. The term paper describes batch calculations, User Requirement Specifications,

Equipment Specifications, and Process Flow Diagram.

• Trained on Team Dynamics, Emotional Intelligence and conflict modes of behavior.

-Culturing of BHK-21 cells using wave bioreactor and stirred tank bioreactor and

purification of IgG Antibody. BioZeen, Bangalore, Jan. to June 08

• In this project, the yield of BHK-21 cells from stirred tank bioreactors that are

agitated with the help of a suspended shaft magnetically driven was evaluated and

compared to the yield from a disposable bag that was agitated by rocking wave

motions. It was observed that the disposable bioreactor yielded cells that were

comparable to the existing mode of cultivation i.e. using the stirred tank bioreactor.

This project gave me an opportunity to learn both upstream processing and

downstream processing of antibody production.

• Carried out Scale-Up strategies in animal cell culture, starting from monolayer

culture to suspension culture and seeding into bioreactor (stirred-tank and

disposable). During scale up performed bench top bioreactor (10L) set up,

Sterilization of bioreactor, aseptic media handling and seeding the reactor.

Certifications

• Certification in “Validation and Regulatory Affairs” at Stevens Institute of

Technology, NJ, USA. March 2014

• Certification in “Biopharmaceutical Production and Engineering” at BioZeen,

Bangalore Biotech labs, India. Feb. 08 to May 08

• Certification in “Proteomics and Genomics” at Best Biotech Research Lab,

Bangalore, India Dec. 07

Skills

Equipment Used: Fermenter (sartorius 40L), homogenizer (APV), centrifuge,

autoclave, bioreactor (sartorius 20L), wave bioreactor (GE healthcare) and tangential

flow filtration, dry heat sterilizer.

Software Skills: MS Office, MS Excel (Spreadsheet preparation and validation), Minitab 16,

M files (Electronic Document Management System).

Activities

Secretary, Student Chapter, International Society of Pharmaceutical Engineering (ISPE)

• Organized different ISPE events like seminars and Industry presentations and

Kickoff meetings.

• Participated in ISPE Supplier showcase (September 2012).

Employment Eligibility

United States Permanent Resident

References

Available upon request

Contact this candidate