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Project Process

Mumbai, MH, 400086, India
August 08, 2012

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B ***, *st floor

Vrindavan C.H.S, Plot No. 11

Sector -29C, Ghansoli, Navi Mumbai

Maharashtra, India


Mobile: 998-***-****


Perceiving a challenging career in professionally managed, system driven organization to contribute my best

efforts towards the interest of the organization in a position that utilizes my skills while furthering my personal

and professional goals as well as to contribute strong quality skills, expertise and experience in Biotechnology

and develop myself as a valuable asset for the organization.


Reliance Life Sciences, Navi Mumbai From September 2007 till 10 Jan 2012

Sartorius Stedim Biotech 10 Jan 2012 to till date

Currently working as Application Specialist – Purification technologies.

Have a 4.3yrs of protein purification and production control in a Manufacturing Facility FDA, WHO and ANVISA


Application specialist – Purification Technologies

Current Work profile in the organization

• Taking care of the applications of Clarification or pre filtration, Cross flow cassettes and systems, Membrane Chromatography and virus filtration.

• Preparing PFD’S for the whole downstream process for purification of proteins and API’S.

• Providing technical guidance to the customers and the end users to increase the productivity, Purity and yield of the desired product.

• Doing trials at small scale to check the working of the application and taking the same process to large scale for the desired yield and purity (Cross flow cassettes and systems, Membrane Chromatography and virus filtration).

• Technical transfer from small scale to large scale.

• Process optimization of the process at all scales.

• Giving customers a technical support for engineered systems and preparation of SOP’S for the same.

• Designing the protein purification steps according to the protein of interest.

Position – Senior Executive

Work Profile in the organization as a Senior Executive

• Expertise in carrying out downstream purification process of therapeutic proteins like albumin, IgG, thrombin, fibrinogen, Factor VIII from plasma.

• Monitoring, Control and troubleshooting of product specific production / process operations.

• Preparation of various SOPS based on GDP guidelines.

• Finalization of Batch Manufacturing Records, and review of the same.

• Actively participated in SAT.

• Carried out validation documentation of Autoclave (ctp, IQ, PQ, OQ).

• Competent enough in allocating shift responsibilities at par and leading the team by getting it done in required time.

• Successful contribution as a team member in Indian FDA, Domestic and International Client audits such as Egypt Audit, IMBS (Irish Medicine Board) and Anvisa.

• Proper Technical coordination with the Quality (required change controls & CAPA) and R and D personnel’s in the company.

• Thorough Knowledge of handling of DCS (Distributed Control system By Siemens PCS 7) and connecting instruments like Autoclave, CIP skid, TFF, Chromatography, sterile & Virus filtration, vial washing, tunnel, filling machine and Pasteurizer.

Technical Knowhow

• Has technical expertise in packing of following types of protein purificative columns like Q Sepharose (70L)

• Well aware of column packing and unpacking skid Millipore.

• Fermentation, Mammalian Cell Culture, Sterilization and CIP, Downstream Processing of Proteins and their purification, Area Classification, Clean Utilities and their generations, Valves and Piping.

• Working in the classified area following c GMP rules and Guidelines and holds the following technical experiences along with their various Troubleshooting.

• Operation and maintenance of Tangential Flow Filtration (millipak).

• Good knowledge of integrity machines.

• Proficient in carrying out Integrity Tests of various types of filters and cassettes like MILLIPAK 100, 60, sterile grade filter etc...

Projects Worked Upon

• Successfully completed project on “MICROBIAL TECHNIQUES” form JIVAS (Jain Institute Of Vocational Studies), Bangalore

• Successfully completed project on “IMMUNOLOGICAL TECHNIQUES” form JIVAS (Jain Institute Of Vocational Studies), Bangalore

• Successfully completed another project on “RECOMBINANT DNA TECHNOLOGY” from Garden City College, Bangalore.

• Successfully completed another project on “PLANT BIOTECHNOLOGY” from Garden City College, Bangalore.

Computer Skills

Precision in working with all the Microsoft Office Tools like MS Word, MS Excel, MS Power Point, etc.

Training undergone

• Six Weeks (17th Sep-26th Oct, 2007) Training in“BIOPHARMACEUTICAL PRODUCTION AND ENGINEERING” at BIOZEEN, Bangalore.

Acquired training in Bioprocess Engineering at BIOZEEN, Bangalore. They were as follows:

• Animal Cell culture- Culturing the animal cells in invitro aseptic condition by maintaining all the parameter required for the cell growth and its maintenance that included passaging, Scale up (From T-25 flask to T-175 flask), Cell counting and studying the morphological characteristics of the cells.

• Microbial cell Culture- Learnt the basics of Microbial Fermentation. Work included process optimization of the various parameters like pH, Temp, DO and Aeration requirement for the cell growth. Calculation of dissolved Oxygen by using four methods (especially KLa method).

• Downstream Processing- Learnt to choose the simplest, cheapest and less time consuming methods for the purification of the proteins. Also included optimization of the parameter for –Centrifuge (Sedimentation, Velocity, RPM, RCF and g-Value), TFF (Flux value, TMP, Flow Rate, Cassette selection) and Column Chromatography (Column size, diameter, column packing and unpacking, column storage) at a small scale. Learnt to check the protein content by SDS PAGE.

• Basics of Filtration Techniques, Sterilization -

1. Learnt the basics of Filtration like- The types of filter that are used for purification and the criteria involved to choose the filter accordingly to the process and the reasons for its selection. Learnt the basic principle of Filter integrity and Filter Validation.

2.Learnt the basics of Sterilization, Types of sterilization, Operation of Autoclave, Operation of DPO and optimizing the time required for the sterilization by D-value(Log reduction value), Z-value(Time require for 1log reduction) and Fo Value.

• District head for the safety monitoring in case of emergency.

Educational Qualifications

Masters in Biotechnology

From Garden City College (Bangalore University), Karnataka with 74% Marks in 2007

Bachelors in Biotechnology

From Garden City College (Bangalore University), Karnataka with 74.5 % Marks in 2005.

Higher Secondary

From CBSE Board, First class with 67 % Marks in 2002.

Senior Secondary

From CBSE Board, First class with 65% in 2000

Personal Details

Name : Mihir Patel

Father Name : Shri Bhupendra Bhai Patel

Date of Birth : 22nd July 1985

Gender : Male

Marital Status : Single

Nationality : Indian

Languages known : English, Hindi, Gujarati, Punjabi.

Hobbies : Cricket, Music, Movies, computer games

Permanent address : Bhupendra bhai patel

Moti khadki


Dist: Borsad

Taluka: Anand



Mihir Patel

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