DHAVALKUMAR JAIN
Hillsborough,NJ
Summary
Dedicated microbiology Management professional with a 16+ years experience in Quality Control, Pharmaceutical, Biologics, Cell therapy and Medical Device Industries.
Talented Manager with expert team leadership, planning, and organizational skills built during successful career.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Manager, Microbiology and Sterility
SGS Pharma
07.2022 - Current
- Develop, implement, and maintain systems to ensure that SGS clients receive top-notch customer service from the Microbiology Department
- The Manager of Microbiology ensures the quality and compliance of microbiological processes
- This role oversees the daily operations of the microbiology laboratory, ensuring that critical deliverables and timelines are met
- Oversee and apply day- to- day knowledge of cGMPs, FDA, USP, MHRA, EP, JP, PMDA, and DEA regulations and guidelines as they relate to pharmaceutical products, cell therapy products, and sterile products, while also maintaining data integrity and good engineering practices
- Ensure validation principles for the URS, IQ, OQ, PQ, PVs, etc., are upheld
- Manage laboratory activities to support GMP manufacturing and microbiological testing of materials, intermediates, and finished products in accordance with FDA/EU regulations
- Conduct method verification activities, including writing protocols and reports, while executing and presenting these to the client in a compliant manner
- Write and review microbiology deviations and trend reports
- Establish the environmental monitoring (EM) program in accordance with FDA/EU regulations and applicable international regulations, as well as cross- contamination strategies and HACCP analysis
- Manage, motivate, coach, and mentor direct reports to build a highly efficient microbiology team and identify and develop key talents
- Conduct annual performance evaluations of all department staff
- Collaboration with cross- functional teams is essential to support product releases, audits, and regulatory inspections, fostering a culture of teamwork and continuous improvement
- Ensure that the lab meets or exceeds budget, cost, volume, and efficiency targets (KPIs) in line with business objectives
- Perform sterility and endotoxin method verifications per USP guidelines and support the implementation of microbiology laboratory practices
- Enforcing aseptic processing in an ISO 5 clean room and bio-safety cabinets is required
- Introduce advanced concepts in the microbiology laboratory to keep it forward- looking and competitive in the industry
- Demonstrate critical reasoning, problem- solving, troubleshooting, investigation, and decision- making skills
- Qualified and certified microbiology lab for the ISO/IEC 17025:2017 biological and chemical testing for medical devices
- Maintain highest quality standards in the laboratory by continuously satisfying more than 80+ vendor approval audits per year
- Successfully completed FDA Audit with Zero Defect Identified in 2023
- Cleared Health CANADA regulatory inspection with no issues observed in 2022
Laboratory Operation Supervisor
Johnson & Johnson Products Inc
01.2016 - 07.2022
- Provided overall Technical, supervisory, and operational oversight to the R&D Microbiology group
- People and Talent: Directing and Coordinating projects to group members
- Set up and Measure Goals and Objective of delegates
- Empowerment and Enrichment team members for their goals
- Providing daily coaching and training to the delegates for their talent development
- Motivation, positive reinforcement, and Promotion based approach for career succession
- Developing and implementing key strategies and policies within the department and across the regions
- Responsible for people requirement and departure process
- Performing IQ, OQ, PQ, for Equipment’s and Validations for the Processes, Vendors and Person
- Compliance: Responsible for outside vendor qualification and training
- OOS/OOT and Laboratory Investigations, Cross functional Investigations, Product life cycle Investigations, Technical trouble shooting and Root cause analysis
- Providing Preventive measures and Corrective actions
- Coordination of team members for nonconformance and metrics
- Writing and revising SOP’s and Worldwide SOP’s, Test methods and work instructions
- Review and revise Microbiology Product specification
- Global Change control and technical wiring for alterations
- Responsible for cGMP compliance, internal audit, and prepared report for FDA readiness
- Provide overall Audit readiness support
- Raw Material Sourcing: Oversight RMC micro qualifications
- Providing Microbiology assessment, Risk Category and Technical justification for RMC changes
- Harmonizing specification across the region
- Product Life Cycle Management: Oversight for product life cycle management microbiology support
- Risk assessment and technical justifications for formula changing, Site transfer, Packaging changes and Raw material changes
- Test Method suitability and transfer to the external sites
- Review method suitability data for Internal requirements
- Stability OOS microbiology support, Specification limits review, external product contamination assessment
- Working with Product Consumer Complains Assessment - To design and develop method to find root cause, provide rationalize report for complaints, suggest different alternatives methods and product design
- Successfully completed JJRC audit in 2018, Internal Audits 5 times (2016, 2017, 2019, 2020), ISO certifications 4 times, Quality Audits with Zero Defect Identified
Team Lead, R&D Microbiology Laboratory
Johnson & Johnson
01.2012 - 12.2015
- Provide overall Technical, supervisory and operational oversight to the group
- Created Lab Metrics (number of failures, stability, lab batches)
- Managed right at first time APR and provided on time delivery
- Oversight for New product launches with risk assessment, APR, Technical justifications for formula changing, Site transfer, Packaging changes and Raw material changes
- Managed and established the onsite Environmental monitoring program
- Ensures that staff training is current and appropriate with their training and compliance
- Writing and revising SOP’s and Worldwide SOP’s, Test methods and work instructions
- Responsible for day-to-day microbiology lab performance
- Provided direction and guidance to preservation, formulations, Microbiological assessments, Approved Product for Release, Risk assessments to supporting business partners
- Worked on transparency commitment projects to reformulate more than 20 baby products Cosmetics, OTC and Drug products
- Worked with global partners to harmonize new product development methods
- Worked on global formula development to launch and register drug product in EMEA, Russia, Carrabin, Latin America, Africa, Australia, New Zealand and Asia Pacific
Microbiologist II
Johnson & Johnson
05.2011 - 01.2012
- Performed IQ, OQ and PQ such as Autoclave, spectrophotometer, water activity meter, Vitek II
- Creating, reviewing & verify to Standard Operating Procedures & specifications
- Performed Test method suitability for finished product testing and transferred that to manufacturing sites
- Team Leader to review and approve Test method validation and transfers of 4 members on team
- Worked on USP equivalency of test methods, and lead role in 700 formulas across 35 external manufacturing sites
- Comparative study for internal standard Test methods with USP, EP, FDA BAM
- Worked with improving lab GMP, and act as back up for Lab Manager
- Worked with Supported to marked product research investigation with consumer complains- To design and develop method to find root cause, provide rationalize report for complaints, suggest different alternatives methods and product design
- Participate in GMP internal audit and prepared report for FDA readiness
- Participate in non-conformances, CAPAs and Safety Investigations
- Reviewed and written nonconformance investigations using standard industry investigation tools
- Provided more than $40,000/ year cost savings by implementation of new reduce testing plan
QC Microbiologist
Colgate Palmolive Company
08.2010 - 05.2011
- Performed and reviewed Preservative Effectiveness Test, Microbial Limits Test, Microbial Content test, Test method Validation, Test method suitability, Water activity meter, Microbial Ruggedness Test, bioluminometer (Celsis),Vitek II, Sterility testing on regular basis
- Performed Growth promotion and sterilization
- Performed Water, Raw material and Finished product testing
- Performed Environmental Monitoring
Lab Technician
Colgate Palmolive Company
08.2009 - 12.2009
- Worked as Lab Technician in the position of Co-Operative Education Program in Microbiology department
- Perform release of raw material, finished products, in process samples
- Primary duties: Water Sampling and testing, Environmental Monitoring, Bioburden Testing
Analytical Biologist
Dr. Reddy’s Lab
12.2006 - 02.2007
- Worked as Analytical biologist to Develop HPLC Method for Amino Acid Analysis
- Derivatized amino acids in various media and discovered acid hydrolysis is best medium for protein hydrolysis
- Investigated retention time for all amino acids by RP-HPLC and compared with unknown protein
- Also discover protein composition of amino acids
Education
Master of Science - Biology
Fairleigh Dickinson University
Teaneck, NJ12.2009
Bachelor of Engineering - Biotechnology
Visvesvaraya Technological University
12.2007
Skills
- Microbiology Laboratory Management
- Quality Assurance
- Environmental Monitoring
- Root Cause analysis- 5Why, Human Error Prevention
- 6sigma tools implementation
- Contamination control strategies
- EMPQs and Media Fills
- Sterility Assurance
- Audits
- Verification of Sterility Methods
- Alternate method validation
Certification
- 02/06/22, Six Sigma: Green Belt, LinkedIn learning
- 01/08/15, Lean Six Sigma White Belt Certification, Management and Strategy Institute
- 12/01/12, Certified Quality Improvement Associate, American Society of Quality
- 09/12/12, Overview of Terminal Sterilization Process, Sterile Process Technology center of Johnson and Johnson, Raritan, NJ
- 08/23/12, Advance fungal Workshop, EMSL Analytical, INC., Cinnaminson, NJ
- 11/01/11, Microbiological Considerations for Non-Sterile Products, Parenteral Drug Association (PDA), Somerset, NJ
- 10/01/11, Current Microbiology and Preservative Updates, Personal Care Product Council, Newark, NJ
- 06/02/11, GMP: Documentation and Record Keeping, BioPharma Institute Program
- 04/01/09, Poster presentation certificate, The American Chemical Society
- 06/01/06, Advanced Diploma in Plant Tissue Culture, Karnataka, India
Publications
Microbiological Methods for Drug Substance, Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Third Edition, 2024 published by: ELSEVIER
Awards
- 10/14/21, Certificate of Excellence, C&G Consulting Group, Inc., Successfully completed 'The 2 new refrigerators qualification within 6 weeks of timeline'.
- 08/10/21, Certificate of Excellence, C&G Consulting Group, Inc., Successfully completed 'The Autoclave Qualification project'.
- 08/13/20, Certificate of Appreciation, C&G Consulting Group, Inc., Outstanding Team management During COVID-19 crisis.
- 05/26/20, Certificate of Appreciation, C&G Consulting Group, Inc., Outstanding performance on 'Compendia Methods harmonization with Internal SOP’s'.
- 04/04/19, Certificate of Appreciation, C&G Consulting Group, Inc., Outstanding performance on 'Lead and Deliver the PCPC methods Implementation in Skillman Micro Lab'.
- 02/02/17, Certificate of Excellence, IPS, Troubleshoot, Root Cause Analysis to Investigate Team management problems.
- 12/15/16, Excellence performance Award, Innovative Pharma Solutions, Managing and Leading Team during crisis with extreme stress condition.
- 06/02/16, Innovation Award, IPS, Leadership & Commitment to Continues Improvement.
- 06/09/14, Award of excellence, Johnson & Johnson, Microbiological Assessment of simulated in use test.
- 08/16/13, Award of excellence, Kaztronix LLC, Performance at Johnson and Johnson.
- 04/25/12, Award of excellence, Kaztronix LLC, Performance at Johnson and Johnson on 'Comparison study between FDA BAM and internal release testing method'.
- 05/01/12, Award of excellence, Kaztronix LLC, Performance at Johnson and Johnson on 'Best performance for consumer complain investigation'.
- 08/01/11, Star award, Johnson & Johnson, Consumer Complain Investigation.
- 03/01/10, Gold award, On Assignment, Performance at Colgate Palmolive Company.
Timeline
Manager, Microbiology and Sterility
SGS Pharma
07.2022 - Current
Laboratory Operation Supervisor
Johnson & Johnson Products Inc
01.2016 - 07.2022
Team Lead, R&D Microbiology Laboratory
Johnson & Johnson
01.2012 - 12.2015
Microbiologist II
Johnson & Johnson
05.2011 - 01.2012
QC Microbiologist
Colgate Palmolive Company
08.2010 - 05.2011
Lab Technician
Colgate Palmolive Company
08.2009 - 12.2009
Analytical Biologist
Dr. Reddy’s Lab
12.2006 - 02.2007
Master of Science - Biology
Fairleigh Dickinson University
Bachelor of Engineering - Biotechnology
Visvesvaraya Technological University
Similar Profiles
Shivam DesaiShivam Desai
Pharmaceutical Manufacturing Operator at SGS Quay PharmaPharmaceutical Manufacturing Operator at SGS Quay Pharma
Gulsanat ZhumagaliyevaGulsanat Zhumagaliyeva
Supervision and Witnessing Expert of Lab Testing at SGS Vostok Limited (SGS Group)Supervision and Witnessing Expert of Lab Testing at SGS Vostok Limited (SGS Group)
T. V. Sambasiva RaoT. V. Sambasiva Rao
GM - HR & Admin at Lyfius Pharma & Qule PharmaGM - HR & Admin at Lyfius Pharma & Qule Pharma