Position Summary: Responsible for developing, implementing and managing systems to mitigate the risk of experiencing unacceptable levels of bioburden in products. This includes establishing best practices, process controls and environmental monitoring programs that reduce the potential for microbial product contamination. Also responsible for training manufacturing associates on aseptic technique and monitoring and coaching production associates at their work stations. Key Responsibilities: •Microbial sampling, identification & bioburden mapping of production facilities. •Bioburden challenge studies for existing and new product formulations. •Bioburden risk assessment and validation for new product development process. •Aseptic process development and process control. •Environmental and water monitoring of Rockford and Wisconsin sites. •Interpret test results and initiate corrective actions as needed. •Assist with equipment and process cleaning validations. •Clean room management inclusive of mentoring and supervising 23 clean room associates. •Microbial test-method development as per USP test method suitability. •Contamination investigations & implementation of corrective actions. •Prepare reports and present data with conclusions. •Maintain microbiology laboratory equipment and supplies. Also efficiently performed Preservative Efficacy Challenge Tests, Environmental monitoring, LAL Endotoxin testing (Kinetic & Gel Clot methods), Microbial Ingress Integrity Testing (both Dye Penetration & Bacterial Challenge testing), Microbial Identification using Biolog, Mycoplasma testing of products using Luminometer, Bioburden & Water testing.

1. Biju Joseph (M.S., Microbiology)
4939 Linden Rd, Apt # 922, Rockford, Illinois-61109, USA.
Home # 518-238-3980, Cell # 779-221-4276
E-mail: bijumarycanada@hotmail.com
16+ yrs Experience in Pharmaceutical, Biotechnology, Cosmetic & Analytical Services
Industries
THERMO FISHER SCIENTIFIC INC: Lab-in-charge QC Microbiologist, Rockford, Illinois, USA (2012 till date).
(ISO 9001:2015 Compliant American Multinational, Biotechnology Product Development organization).
Position Summary:
Responsible for developing, implementing and managing systems to mitigate the risk of experiencing unacceptable levels
of bioburden in products. This includes establishing best practices, process controls and environmental monitoring
programs that reduce the potential for microbial product contamination. Also responsible for training manufacturing
associates on aseptic technique and monitoring and coaching production associates at their work stations.
Key Responsibilities:
 Microbial sampling, identification & bioburden mapping of production facilities.
 Bioburden challenge studies for existing and new product formulations.
 Bioburden risk assessment and validation for new product development process.
 Aseptic process development and process control.
 Environmental and water monitoring of Rockford and Wisconsin sites.
 Interpret test results and initiate corrective actions as needed.
 Assist with equipment and process cleaning validations.
 Clean room management inclusive of mentoring and supervising 23 clean room associates.
 Microbial test-method development as per USP test method suitability.
 Contamination investigations & implementation of corrective actions.
 Prepare reports and present data with conclusions.
 Maintain microbiology laboratory equipment and supplies.
REGENERON PHARMACEUTICALS, INC: Senior QC Microbiologist, Rensselaer, New York, USA (2009 to 2012).
(FDA registered cGMP compliant organization).
 Responsible for QC Microbiological aspects of cGMP compliance and testing.
 Set up the Validation Lab, Purchased Equipments and qualified them for testing.
 Performed Microbiological Validations as needed for finished product, in process controls & buffers.
 Assisted manufacturing personnel in the identification of microbiological root cause analysis & provided
technical advice as needed.
 Participated in cleaning and process validation activities to help manufacturing as needed.
 Participated in the investigation of microbiological product OOS results and DNF as needed.
 Contributed to the preparation of technical protocols, amendments, reports and memoranda.
 Contributed toward creating and revising microbiological SOPs through change control procedure in eDoc
Compliance system.
 Assisted in the review of Environmental monitoring and product release data in LIMS.
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2. IRVINE PHARMACEUTICAL SERVICES: Microbiology Group Leader, Irvine, California, USA (2007 to 2009).
(FDA registered cGMP compliant organization).
 Interacted with external clients to include delivering on time and accurate information on product test reports.
 Interviewed prospective Microbiology candidates for hiring/recruitment into the organization.
 Monitored Departmental activities to ensure work was completed within the targets for budget and timelines.
 Initiated, Wrote, Updated, Reviewed, and Approved Laboratory Standard Operating Procedures, Analytical
Methods and Specifications.
 Assisted Lab Manager in Method developments & Method Validations to meet client requirements.
 Interacted closely with the Quality Assurance group to ensure compliance with all cGMP & other regulatory
requirements.
 Efficiently performed Preservative Efficacy Challenge Tests, Environmental monitoring, LAL Endotoxin testing
(Kinetic & Gel Clot methods), Microbial Ingress Integrity Testing (both Dye Penetration & Bacterial Challenge
testing), Microbial Identification using Biolog, Mycoplasma testing of products using Luminometer, Bioburden &
Water testing.
 Supervised & Assisted Lab Personnel performing Sterility, Growth promotion tests & D-value testing.
 Provided Motivation, Leadership & Structure to the Department.
CRYSTAL CLAIRE COSMETICS INC: Lab-in-charge QC Microbiologist, Toronto, Canada (2006-2007).
(cGMP compliant organization).
 Lab-in Charge for Microbiological testing and releasing of Finished Products, Batches, Raw Materials, Health &
Beauty Skin Care products inclusive of Growth promotion, Enrichment & Pathogen testing.
 Performed routine Microbiological & testing of Purified Water & Environmental monitoring.
 Wrote & Reviewed SOP’s, Protocols & Reports related to QC Microbiology.
 Trained & Supervised Microbiology technicians.
BODY BLUE INC: Senior QC Microbiologist, Mississauga, Canada (2004-2006).
(FDA registered cGMP compliant organization).
 Performed Microbiological testing and releasing of finished products, Batches, Raw materials, OTC products,
shampoos, skin care lotions, gels, deodorants inclusive of Growth promotion, Enrichment & Pathogen tests.
 Validated Celsius Advance ATP bioluminescence Technology for Beauty Home & Health testing.
 Supervised Routine Microbiological & testing of Purified Water & Environmental monitoring.
 Wrote & Reviewed SOP’s, Protocols & Reports related to QC Microbiology.
PATHEON INC (PHARMACEUTICALS): Processing Technologist, Mississauga, Canada (2004).
(FDA registered cGMP compliant organization).
 Processed OTC products, equipments & rooms according to written SOP’s & established cGMP’s ensuring that
product quality met TPP & FDA standards.
 Prepared manufacturing areas & equipments for the production of Pharmaceutical products.
NATURAL REMEDIES PHARMACEUTICALS PVT LTD: QC Microbiologist, Bangalore, India (1999-2003).
(ISO 9001, ISO 22000, Kosher certified registered, cGMP certified organization).
 Performed QC Analysis & Research related to raw materials and finished products, inclusive of OTC products,
powders, creams, liquids, and tablets & maintained their database.
 Performed Bioautography and Microbiological Assays of different compounds for their potency.
 Supervised Routine Microbiological testing of Purified Water & Environmental monitoring.
 Prepared Buffers & Reagents. Procured lab supplies & glassware for analytical processing.
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3. ACCOMPLISHMENTS
 Reduced microbial contamination complaints by 43% by revising the clean room gowning procedure at Thermo
Fisher Scientific, Rockford.
 Generated additional value added business of $2,500/yr, leading to continued operation and growth of the lab by
providing water testing service for Thermo Fisher Scientific, Wisconsin.
 Designed a new product testing procedure for an external customer, obtained approval for new procedure leading
to the increased development and testing capability of the lab by generating revenue of $550 cost/test at Thermo
Fisher Scientific, Rockford.
 Designed and performed microbial challenge study on ten products and saved $9000/yr for Thermo Fisher
Scientific, Rockford.
 Introduced cost saving Practical Process Improvement Endotoxin testing at Regeneron Pharmaceuticals, NY.
 Validated ATP Bioluminescence technology for different products at Body Blue, Canada.
 Reduced the analysis turn around time from 5 days to 2 days using automated technology at Body Blue, Canada.
 Was a member of the successful team at Natural Remedies, India that discovered a new formula for Colgate-
Palmolive
EDUCATION, VOLUNTEERING AND TEACHING EXPERIENCES
 Completed training on “Quality System Regulations-21 CFR Part 820” for Medical Devices cGMP at Thermo
Fisher University-2017.
 Completed training on the following leadership modules at Thermo Fisher University-2016.1) Role Model
Leadership (RML) 2) How to be a Successful Mentor 3) Seven Transformations of Leadership 4) Coaching 5)
Managing Others.
 Volunteered every Monday night for 2.5 hrs throughout the year as a mentor for the 2nd
grade kids at the nonprofit
organization called Rock House Kids in Rockford, whose mission is to foster and provide a safe and nurturing
environment to” at risk kids”.
 Volunteered as a Supervisor and represented Thermo Fisher Scientific annually at the Regional Science Olympiad
competition that was conducted at the Rock Valley College to judge the “Forensics” event and grade two different
sessions of the exams for the C division school students belonging to twenty three schools of the Winnebago
County.
 Volunteered and helped kids with special needs participate in the spring games event at the Special Olympics
which was conducted at Harlem High School, Machesney Park, IL-2014.
 Attended “Clean Room and Pharmaceutical Water Regulations” Workshop, Chicago, IL-2015.
 Attended “Rapid Microbiology Test Methods” Workshop, Bethesda, MD-2013.
 Attended “Train the Trainer” Leadership & Management course at Regeneron, NY-2011.
 Attended “Portable Fire Extinguisher Training” at Regeneron, NY-2011.
 Attended the “PMF Fall Forum Workshop on Validation”, Rochester, NY-2010.
 Attended the “PMF Bacterial Endotoxin Summit”, Washington, DC-2010.
 Attended the training on “Microbial ID by DNA Sequencing” by Accugenix at Regeneron, NY-2009.
 Attended the training on “Workplace Bloodborne Pathogens” by OSHA, Irvine, California-2008.
 Attended “Train the Trainer”-Leadership & Management course, Irvine, California. 2007.
 Attended “Advance Training in Beauty Home & Health testing” by Celsis Inc, Chicago. 2005.
 Lecturer: Microbiology Dept, Garden City College & National College, Bangalore University. 1997-1999.
 M.S., Microbiology, University of Bangalore, Bangalore, India. 1997.
 Presented seminars on Aflatoxin & Biodegradation of Industrial wastes, Bangalore University. 1996.
 Completed Chromatography course, St. Joseph’s College, Bangalore University. 1994.
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