Process Manufacturing
Resume:
Mohammad Naeem Rajput
****************@*****.***
Ph 510-***-**** Cell, 510-***-**** Home
Subject: Microbiology Technician -
Education:
Contra Costa College San Pablo, CA, Biotechnology Certificate course 1996
Laney College Oakland, CA; Associate Science Degree (Chemistry), 2006
Cal State University of San Francisco; Bachelor of Science (Biochemistry), expected December 2012
QUALIFICATION SUMMARY
Fully experienced and knowledgeable of biotechnology processes/operations, trained to execute operational procedures required for manufacturing of bio-therapeutic medicine such as Factor VIII Protein from mammalian cell culture for hemophilia and performing fill and finish operation of the final product
BIOREACTORS/FILTERATION SYSTEM :Hands on experience and fully knowledgeable at operating and maintaining cell culture bioreactors (100L, 200L, 300L, 1000L) in batch, fed-batch, and perfusion modes, able to terminate, clean, CIP/SIP build up. Working knowledge on assembly/disassembly and operations of cell separation skid, TFF (Tangential Flow Filtration System), ultra filtration system, chromatography column, Sartocheck 3 Filter Integrity Tester and cleaning ultrasonic systems.
ANALYTICAL/SUPORTIVE EQUIPMENTS Proficient running, maintaining, standardizing, and trouble shooting of Analytical instruments such as : NOVA Analyzers, pH meters, CO2 Analyzers, pH and DO, Calcium analyzer ,TOC meter, Spectrophotometer, conductivity meter, and computerized cell counter Centrifuge. HPLC systems, and densitometersHPLC systems, and densitometers
LAB SKILLS: Working knowledge formulating and preparing: media, buffers, solutions, solvents and dilutions for fermentation and Purification uses. Adept at entering and processing data, monitoring process trends to maintain the quality of the product, recording and analysis of analytical data, running batches, maintaining Clean room facility and equipments, controlling and tracking raw material inventory in database.
PROCEDURES: Strict adherence to SOPs with GMP. Understanding of controlled environment, aseptic processing principles, and manufacturing safety regulations. Able to complete and review production documents in real time. Experience with on-going training programs to enhance technical proficiency, regularly assisting staff development in areas such as cGMP training, technical skills, and manufacturing to run the process smoothly, identify technical, procedural and equipment issues that hinder production and compliance, identify deviations and follow through on corrective and preventative actions (variances), review and make recommendations for change to cGMP documentation such as Standard Operating Procedures and Batch Production Records.
Experience
Solazyme South San Francisco February 2011 to April 2011
FERMENTATION FILTRATION PROCESS ASSOCIATE (CONTRACT)
• Performed CUNO depth filter and piping set up cent rate preparation with body feed Diatomaceous Earth (DE) Pre-Coat DE, and application onto CUNO Depth Filters.
• Ran and monitored CARR P12 Centrifugation and conducted Centrifugation sample analysis.
• Daily operations of TFF and analysis of samples.
Genentech, South San Francisco, CA October 2008 to October 2010
MANUFACTURING ASSOCIATE FILL & FINISH
• Pressure tested utility vent and Lyophilizer filters.
• Prepared and ran vial washing capping machines.
• Capped product collecting samples and inspected vials for integrity and sealing.
• Performed Clean room operations.
• Cleaned, loaded, unloaded Lyophilizer, and maintained clean room area.
• Worked with CIP and SIP Lyophilizer, and Product transfer Line.
• Reconciliation vials, removing and cleaning the filler components and Pumps.
• Completed the documentation required at each processing steps.
• Performed sterile preparation of filling processing components.
Genentech South San Francisco May 2008 to July 2008
CELL CULTURE PILOT PLANT ASSOCIATE (CONTRACT)
• Prepared organisms flasks from frozen vials for inoculation and production of cell culture (growth hormones) then inoculate 10L, 20L fermenters.
• Performed CIP, initial preparation and sterilization of small scale production bio-reactors.
• Monitored trends of running process, documented processing data for every two hours to maintain and check the integrity of the culture and produce quality products.
• Collected and diluted culture samples and check cell density to maintain the normal growth pattern of the organisms.
• Proficient in using Bio-reactors, Product Vessels, and centrifuge controlled with HMI screen to perform associated processes: CIP of SIP, setting up set points for PH, temperature, and dO2 .and monitoring the parameters during process.
Kosan Bioscience, Hayward, CA March 2007 to March 2008
PROCESS ASSOCIATE
• Produced and processed bacterial culture protein of anticancer agent Hsp90 inhibitors and Leptolstatin, via fermentation.
• 150L, 500L and1000L bio-reactors for large scale culture.
• Monitored and collected the harvest samples for chemistry and titer to make sure normal growth pattern and quality product.
• Filter harvest to remove the impurities (different fractions of Anguinomycin)) and get it ready for purification.
• Neutralized, disassembled, cleaned and assembled bio-reactors.
• Prepared, autoclaved and aseptically connected tubing manifolds to bio-reactors. Prepared Media, Acid, base and Antifoam vessels and connected to running bio-reactors to maintain growth of the culture.
• Ordered, chemicals parts and gowning needed for fermentation operations Performs environmental checklist to monitor the differential pressures, internal environment, incubator sterilizers, and refrigerators, functional status.
• Purification Duties (Chromatography)
• Cleaned pressure tested and set up and operated various BPG Chromatography Columns to the remove the fractional impurities and get the final product.
• Prepared and Maintained HP-20, HP20SS, XAD and C-18 Resin use in chromatography columns to remove the impurities Packed.
• Cleaned and equilibrated columns for impurities isolation.
• Run and monitored the products, Prepared TIRS, and Methanol solvents for cleaning and fractional separation.
• Collected samples for HPLC to check the product recovery. Performed in-process sampling and testing whenever required.
Genentech South San Francisco, CA September 2006 to December 2006
CELL CULTURE PILOT PLANT ASSOCIATE FILL & FINISH
Cleaning, preparing and Auto Calving Parts /Components for filling operations
Pre and Post Pressure testing of Utility vent and Lyophilizer filters.
Preparing and running vial washing capping machines
Capping the product, collecting samples and inspecting vials for integrity and sealing
Performing Clean room operations: Fill Check, monitor filling process.
.Cleaning ,loading, unloading Lyophilizer,and walk through the clean room area
CIP and SIP Lyophilizer, and Product transfer Line. Helped Mechanic setting up Pumps, filler parts .Change over and macinbility, Performed aseptic filling, Fill checks of product.
Reconciliation vials, removing and cleaning the filler components and Pumps
Completed the documentation required at each processing steps.
Performed sterile preparation of filling processing components.
Bayer, Biological Product Division Berkeley, CA April 1997 to November 2005
MANUFACTURING ASSOCIATE FERMENTATION/MEDIA
• Processed and produced rFVIII, a mammalian cell culture protein. for hemophilia
• Tested, operated, assembled, and disassembled placed and started, 15L, and 30L scale up and 110L Applikon, bioreactors for the production of rFVIII protein.
• Cleaned, CIP, sanitized, assembled and operated main process equipment’s as well as supporting equipment’s according to SOPS and BPRS.
• Operated bioreactors, settlers, Cell separation/Ultra-filtration skids & parts Performed aseptic Connections of Media and solutions to the bioreactors
• Collect culture and harvest samples, performed cell count, sterility check, and Chemical analysis for dissolved Oxygen, CO2, glucose, lactate, pH and CaCl2 to check the integrity of the growing culture.
• Monitored product’s parameters, trouble shooting, made adjustments to the bioreactor, settlers, Ultra filtration Tissue Culture system and Cell Separation Filtration system to keep the product within specifications Performed and reviewed batch production records for all process steps
• Worked in a cGMP environment, practiced good aseptic technique and followed SOPs/Batch Production Records Ordered and tracked production supplies for manufacturing requirement Maintained good housekeeping throughout the laboratory all the time.
• Trained (hands on), new associates, explained the concepts and procedures, and signed off the training records.
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