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Biotech Manufacturing/ Upstream process

Malden, MA
August 27, 2012

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Maulin Shah

**, ******** ******, ***#***

Mobile: 917-***-**** Malden, MA-02148 Email:


• Three years of work experience in bio-process and pharmaceutical cGMP manufacturing industry.

• Graduated in M.S pharmaceutical manufacturing engineering with bioprocess graduate certificate.

• Experience with process validation, CIP/SIP validation of equipments and commissioning of bioreactor.

• Experience with change control, continuous improvement, CAPA and investing manufacturing issues.

• Strong leadership, team work, communication, management, problem solving and inter-personnel skill.


Goldey Beacom college, Wilmington, DE

MBA- Comprehensive. Jul12-current

Stevens Institute of Technology, Hoboken, NJ

Master of Science in Pharmaceutical Manufacturing Engineering, GPA: 3.63/4.0

Date of Graduation: December 2009.

Oxford College of Pharmacy, Bangalore, India

Bachelor of Pharmacy, GPA: 3.5/4.0

Date of Graduation: October 2006.


Biogen Idec, Cambridge-MA Mar’10-Jun’12

Upstream- Manufacturing associate.

• Operate and troubleshooting of bioreactors, filter transfer station, wave-bag bioreactor, Centrifuge, Micro-filtration system, UF/DF skid, depth filtration harvest skids and chromatography skid.

• Perform media addition, equilibration of media, product transfer, base addition, anti-foam addition and nutrient addition of bioreactors.

• Sampling of the bioreactor and analyze the sample for pH, pO2, pCo2, glucose, lactose, viability and VCD of the cell culture.

• Experienced with aseptic and sterile process cGMP working environment.

• Perform environmental monitoring and personal monitoring during aseptic or sterile process.

• Perform cold start, pressure test, automated CIP and SIP of the bioreactors, filter transfer station, product hold tank and centrifuge.

• Perform pressure test, CIP, water flux test and buffer prime of micro filtration and depth filtration skid.

• Perform preventive maintenance and visual inspection of equipments as per requirement.

• Participated in quality leadership program, document & BPR review and continuous process improvement.

Validation & commissioning project experience

• Perform commissioning of CIP for different equipments with engineering run and confirmation run.

• Assist in riboflavin test for CIP spray ball coverage test of the bioreactors.

• Familiar with URS, FRS, DDS, VIT, FAT & SAT. Also participated in SAT of bioreactors.

• Perform CIP/SIP validation run per protocol and collect samples per protocol requirement.

• Temperature mapping run and SIP validation run using KAYE validator.

• Assist to write down and improvement of different validation protocols.

• Perform swabbing of bioreactors and other equipment per given validation protocols.

• Assist to install biological indicator and thermocouple during SIP validation of bioreactors and its different ports per validation protocols.

• Performed pressure control test, temperature control test and agitation control test of bioreactor per operational qualification protocol.

• Assist to write down SOPs for different equipment and field verification of SOPs.

Acme skincare Pvt Ltd. Ahmedabad-India Jan’07-Dec’07

Industrial Trainee

Observe and understand manufacturing facility management, tablet press, granulation process, gelatin capsule manufacturing and fluid bed drying process. Understand different cGMP flow, other related process operation & cGMP aspect. To assist quality department, document management and understand SOPs.

Graduate certificates:

Bioprocess Systems in Pharmaceutical Manufacturing: It includes overall biotechnology processes including upstream process and downstream process, design and piping requirement of equipment, requirement criteria for sterilize an equipment, challenges during clean in place of bioreactors, tangential flow filtration, centrifuge and other equipments; bio-Pharma facilities design concepts, and sterile facilities approaches.

Project Engineering in Pharmaceutical Manufacturing: It includes introduction to project management concepts, economics and cost analysis, specific implementation concepts for sterile facilities, and the newer PAT concepts.

Pharmaceutical Mfg. Practices: It includes all basic manufacturing processes for solid and semi-solid dosage form; facilities design issues, cGMP regulation and requirements, validation and regulatory affairs concepts which drive the industry.


Knowledge Areas: Validation of CIP/SIP, cGMP, PAT technology, dia-filtration, tangential flow filtration, Six Sigma approach, Sterile in place, clean in place, Project Management, Management and Design of pharmaceutical and biotech facilities.

Lab skills: Performed HPLC chromatography analysis, sterile technique, Titration techniques,

Microbiological assays, performed dissolution, disintegration, and friability test for tablets.

Equipments: Blood glucose analyzer, YSI biochem analyzer, Integrity tester, Conductivity meter, pH meter, Cedex analyzer and Osmo meter.

Software: Delta-V, SBOL, SIP trend, Discoverant, Pi-trend, Windows XP, Microsoft Office, MS Project & MS Visio.


Controlling and Monitoring System in Bioreactors - Reported critical process parameters in bioreactor and necessary parameters to be controlled during bio-reactions with details. Report the different sensors to monitor those parameters.

Preliminary design of sterile facility - Presented details of capacity analysis, list of requirements, different options for facility with all cGMP flows, schedule and budget for the sterile facility with positive and negative aspects of facilities.

Process design requirement for Biotech facility - Reported facility layout with room sizing and equipment sizing based on required production capacity for clinical trials, list of required equipments, all cGMP flows, and process flow diagram.

PAT in Roller Compaction - Described how to apply Process Analytical Technology in roller compaction by controlling minimum parameters, also presented brief details of univariate analysis and multivariate analysis with design of experiment.

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