JAI P. SINGH, CQA

***** ******** *****, ******* *****, VA 20165; Cell: 703-***-****;

email: acgjid@r.postjobfree.com

SUMMARY

Accomplished and innovative leader providing technical leadership, training

and hands on experience in development, validation and implementation of

innovative processes for quality reagent manufacturing for in vitro

diagnostics from initial discovery phase to final implementation in

manufacturing following best practices and regulatory guidelines. Certified

quality auditor with extensive background in continuous process improvement

in manufacturing and implementation in a FDA, EMA, CAP and CLIA regulated

environment. Management of cross-functional team and providing leadership

focused on ensuring quality and compliance strategies, goals, policies,

procedures, and objectives consistent with corporate policies, government

regulations, international standards, and standards of the medical device

and IVD following GMP. Experienced in technical and operation management,

quality assurance/quality control (QA/QC), automation, equipment

qualification and validation (IQ, OQ & PQ), process validation, vendor

qualification, hazardous waste management, teaching and training personnel

on compliance in a regulated environment (FDA, EMA, EPA, CAP and CLIA).

Experienced in investigating and auditing manufacturing facilities

(domestic and international) providing support for drug and assay

development process while implementing corrective and preventive action

plan for quality improvement. Exceptional business development, problem

solving, communication, coaching and teaching skills with strong business

acumen.

CORE COMPETENCIES

Quality Assurance & Quality Process Development cGMP/GLP Audit

Control

Project / Program Management Process Improvement Reagent Development (IVD)

Product Development (IVD) Research & development Regulatory Compliance

Analytical Methods Development & Contracts Management Cost Negotiation

Transfer Vendor Qualification GMP Manufacturing

Process Validation & Transfer

Intellectual Property Review & Clinical Trials SOP Development

Approval Support

Scientific Review, Evaluation & Technical Report BioRepository Management

Approval writing

Cryogenic Storage & Distribution Business Development Hazardous Waste Management

Personnel Management & Training Budgeting & Lean Six Sigma

Forecasting

PROFESSIONAL EXPERIENCE

Fina Biosolutions, Rockville, MD

1/12 - Present

QA/QC and Regulatory Compliance Officer/Technical Consultant

Responsible for providing technical, QA/QC and regulatory guidance on

developing polymer based diagnostics reagents from initial discovery phase

to the final implementation in manufacturing following regulatory

guidelines (GLP, GMP, FDA, CAP and CLIA). Provide technical review and

evaluation of the synthetic methods of diagnostics reagents. Assist in

analytical method development for testing of raw materials, in-process and

final products and then implement in manufacturing for measuring quality

and consistency of the product. Evaluate and develop vendor qualification

process for raw materials and help develop specifications for raw

materials, in-process product and final product testing for lot-to-lot

release meeting quality and consistency in manufacturing.

o Develop project plans and provide technical guidance to academic and

industrial scientists on developing diagnostics reagents under GLP/GMP.

o Review and evaluate protocols for reagents development, QA/QC protocols

and plans for accomplishing tasks during research and development and

final implementation in manufacturing for diagnostics reagents following

GLP, GMP, FDA, CAP and CLIA requirements.

o Provide technical guidance for development of synthetic methodology for

production of reagents from small scale to bulk production following GMP

and CLIA guidelines.

o Develop academic and business partnership for stability and efficacy

testing of reagents in academic as well as industrial laboratories.

o Develop procedures and protocols for quality system, vendor

qualification, audit and corrective and preventive action plans (CAPAs)

for continuous improvement.

o Provide guidance on bringing automation in laboratory and prepare

installation, operation and performance qualification (IQ, OQ and PQ)

documents and implantation following GMP.

o Develop and implement batch records for manufacturing of diagnostic

reagents.

Thermo Fisher/Fisher BioServices, Rockville, MD

2012 - 2013

Team Leader; Program and Regulatory Compliance Management/Consultant

Responsible for providing consulting services for technical, quality

assurance and control (QA/QC) management, business development and staff

management for biospecimen collection, storage, processing and distribution

for research and commercial Biobank. Write technical proposals and

marketing documents for Biospecimen management and importance of sample

management from cradle to grave following best practices.

o Developed and wrote technical proposals, quality assurance/control

(QA/QC) plans, equipment maintenance and health and safety plans for

Biospecimen management following GMP/GLP while maintaining regulatory

compliance supporting Government Contract and commercial cell banks.

o Wrote technical marketing and business development documents for specimen

collection, storage and distribution from BioRepository following best

practices.

o Provided guidance on pre-analytical variables for maintaining quality of

biospecimen storage, processing and distribution for research following

GLP, GMP, FDA, CLIA, CAP, DOT and OSHA requirements.

o Audited laboratories and wrote final report for corrective and preventive

action (CAPA) plans for continuous improvement ensuring compliance.

BioReliance Corporation, Rockville, MD

2006 - 2011

Principal Investigator/Project Director (Government Contract & Laboratory

Services)

Responsible for Government, Commercial contracts management and

Biorepository management for storage, processing and distribution and

inventory of biospecimen for cancer biomarker research following best ISBER

practices. Identify laboratories, solicit proposals, review proposals and

provide assessment for feasibility of cancer biomarker assay development,

negotiate cost, audit subcontractor, award subcontracts and manage program

supporting multiple projects. Responsible for auditing laboratories

providing support for biospecimen collection, distribution and inventory

management for research, clinical trials and drug development under GLP/GMP

in FDA and EMA regulated environment. Investigate and audit laboratory

operations (domestic and international) for assay development, cell banking

services and provide guidance, education, knowledge and experience in

BioBanking following best practices. Procure capital equipment for sample

processing, sample storage, temperature monitoring and inventory

management. Develop IQ, OQ and PQ protocols and complete implementation

while increasing specimen processing capabilities and reducing cost. Manage

department budget and resources and maintain regulatory compliance.

o Reviewed solicited technical proposals, evaluated technical aspects of

the proposals and provided recommendations to NCI Principal Investigators

for the award of the subcontract to analyze cancer biomarkers.

o Implemented approved subcontract proposals for assay development. Managed

multiple on-going subcontracts awarded via competitive selection and cost

negotiation process thus reducing cost by 40%.

o Effectively managed research program & provided bi-weekly, monthly and

yearly progress report and financial reports on all aspects of contracts

and assay development support to Government. Maintained high level of

communication at all times on subcontracts and provided progress report

to Principal Investigators (PIs).

o Reviewed and evaluated analytical data and communicated to Principal

Investigators (PIs). Provided consultation, logistical and technical

support to Government Principal Investigators on the work performed by

subcontractors.

o Developed and implemented material transfer agreements (MTAs) and

streamlined biospecimen transfer reducing turn around time by 50%.

o Established BioRepository in India, China and Mongolia for collection,

processing and distribution of research and commercial biological samples

under GLP and GMP. Developed and implemented standard operating

procedures (SOPs) for specimen collection, processing, storage and

distribution following best practices while reducing operational cost and

increasing revenue by 70%.

o Established BioReliance's European BioRepository and provided guidance

and knowledge on logistical support following best practices for specimen

collection, storage and distribution supporting international customers

increasing revenue 30-50%.

o Developed and presented strategies and cost model for domestic and

international business for BioBanking storage and distribution support

increasing storage capacity by 80%.

o Reviewed, evaluated and implemented laboratory automation procedures

reducing sample processing time by 40% improving efficiency and quality

in sample processing in the laboratory.

o Developed and implemented IQ, OQ and PQ protocols, preventive maintenance

and validation of equipment ensuring compliance.

o Evaluated and reviewed standard operating procedures (SOPs) and

implemented process improvements via training laboratory personnel and

account managers in US and Europe for customers complying with GMP/GLP in

FDA and EMA regulated environment.

o Evaluated, procured, developed and implemented quality assurance and

control plans (QA/QC) for automated temperature monitoring system in the

BioRepository meeting FDA and EMA compliance requirements.

o Reviewed QA/QC data on a daily basis and approved for regulatory

compliance. Closed corrective and preventive action plans (CAPAs) in a

timely manner ensuring laboratory compliance.

o Managed interdisciplinary research program, motivated and trained

personnel on all aspects of safety, security, and regulatory functions

meeting organizational goals and objectives while providing opportunities

for learning, growth, and development.

o Audited subcontractor laboratories (academic as well as commercial) for

their QA/QC program, training records, assay protocols as well as

equipment validation records prior to conducting assays. Opened

corrective and preventive action plans (CAPAs) for improvement to ensure

compliance.

o Developed and implemented environmental health and safety procedures

(SOPs) for personnel working in cryogenic storage area. Trained

laboratory personnel on safe working practices in the laboratory meeting

OSHA guidelines. Managed installation of oxygen sensors for the cryogenic

storage area.

o Hosted regulatory (FDA, EMA) and commercial client audits. Provided

closure on matters pertaining to audit.

US Patent and Trademark Office, Alexandria, VA

2005 - 2006

Patent Examiner

Review technology, examine and evaluate patent applications and determine

the patentability of the intellectual property based on prior scientific

literature searches and reviews. Determine allowance of the patent

applications by communicating with applicants to resolve any

inconsistencies leading to the patentability of new technologies.

o Reviewed intellectual properties and technologies and evaluated new

patent applications and communicated office actions based on categories

of inventions and the patentable technologies.

o Conducted prior literature searches related to the patent applications

and determined the patentability of the inventions based on critical

examination and review of technology based on legal statutes and

guidelines.

o Conducted patentability conference with applicants and/or legal entities

prior to allowance of patents ensuring quality and consistency within

legal time constraints.

o Provided guidance to patent applicant's legal representative to

articulate the technology for patent approval.

QUEST DIAGNOSTICS/ AML, INC., Chantilly, VA

1998 - 2005

Technical Manager, Reagent Development

Manage, supervise, develop, direct, recruit, train laboratory personnel

required for the development, implementation and manufacturing of high

quality in vitro diagnostics reagents. Responsible for budgeting and

overall function of the department under established financial guidelines.

Establish and implement hazardous waste management program for the entire

organization. Evaluate and manage inventory of raw materials for

manufacturing of final products ensuring consistency and quality while

maintaining efficiency and productivity under regulatory environment.

o Managed overall functions of the department and improved processes in GMP

environment and reduced

operational cost yielding annual cost savings of $100,000 a year.

o Reviewed SOPs and batch records for manufacturing of reagents.

Implemented improved manufacturing process of reagents and final products

reducing cost by 60%, decreasing back order and significantly enhancing

customer satisfaction.

o Evaluated and developed specifications for raw material testing, in-

process products testing and final product testing and then implemented

specifications in manufacturing.

o Developed and implemented quality assurance and control procedures

(QA/QC) for stability testing of raw material, in-process product and

final product meeting specification ensuring quality of the products in

manufacturing.

o Conducted vendor audit for raw material manufacturing facility and

distribution to ensure quality and lot-to-lot consistency of raw

materials meeting specifications. Opened corrective and preventive action

plans (CAPAs) for improvement.

o Conducted internal audit for training records, equipment validation,

assay procedures and manufacturing process for consistency and quality.

o Reviewed and implemented standard operating procedures (SOPs) for the

department based on six sigma quality principles.

o Developed and implemented SOPs for standards and controls for drug

analysis in the clinical and forensic toxicology laboratory. Guided

medical technologists in the laboratory for maintaining chain of custody

of drugs.

o Reviewed and approved manufacturing documents, batch records, change

control and maintained records for compliance.

o Coached and empowered personnel to learn new technologies and become

knowledgeable on technical operations of the department resulting in an

excellent environment for learning and professional development.

o Established cross-functional team to develop hazardous materials training

program for the technical laboratories reducing collection and disposal

cost by 40%.

o Hosted CAP and CLIA audits for reagent manufacturing facility and

provided closure to CAPAs.

LIFE TECHNOLOGIES, INC., Rockville, MD 1996

- 1998 Staff Scientist/Technical Manufacturing

Responsible for managing and developing cost effective synthetic processes

for nucleotides and determine their quality using High Performance Liquid

Chromatography (HPLC) and Capillary Electrophoresis (CE). Participate,

educate and resolve manufacturing related processes on an on-going basis in

research & development and manufacturing in GMP environment.

o Reviewed and evaluated literature and conducted feasibility study for

synthetic methods suitable for production of products meeting quality and

consistency while reducing waste in manufacturing process.

o Developed an efficient manufacturing process for the synthesis of

nucleotides using enzymes to improve the quality, reduce synthesis time

and save cost (> $500,000 a year).

o Reviewed analytical methods and developed specifications for raw

materials, in-process products and final product using HPLC and CE

(analytical method) and implemented in manufacturing to measure lot-to-

lot release ensuring quality of raw materials and final products.

o Developed and implemented HPLC and CE methods for the separation of

nucleosides, nucleotides to monitor the quality of raw materials, in-

process and final product in manufacturing and quality control/assurance

(QA/QC).

o Reviewed and approved manufacturing batch records for accuracy,

consistency and quality prior to release of the products.

o Performed troubleshooting and issue resolution for products in

manufacturing on an on-going basis.

o Audited internal and external manufacturing facility for compliance.

Issued corrective and preventive action plans (CAPAs) for improvement and

efficiency meeting compliance.

o Reviewed and approved change control document and maintained

manufacturing records for compliance.

o Reviewed and approved training records, validation records of equipment,

validation protocols and manufacturing process to ensure compliance in a

regulated environment.

o Developed instrument qualifications (IQ, OQ and PQ) for analytical

instruments and implemented in technical manufacturing department.

Validated analytical methods for raw materials, in-process and final

products.

o Managed and trained a cross-functional team for the implementation of the

product in manufacturing.

o Attended professional conferences for learning new technologies.

BAXTER/DADE DIAGNOSTICS - MICROSCAN, INC., West Sacramento, CA 1990

- 1996

Senior Scientist/Formulation Development and Manufacturing (1993 - 1996)

Scientist III (1990 - 1992)

Manage, supervise and direct a cross-functional team involving R&D, pilot

plant, manufacturing and quality assurance for development, validation and

implementation of in-process specifications of critical raw components, in-

process products and formulations using HPLC and CE. Establish a chemical

laboratory for research and development and then transfer the process in

manufacturing for production of fluorogenic substrates in bulk quantities

under GMP meeting FDA requirements. Establish and implement vendor

evaluation process for critical active ingredients for manufacturing of

products ensuring quality and consistency by reducing variability in the

process. Supervise personnel in research and manufacturing laboratories and

maintain zero defects.

o Developed, validated and implemented permanent fluorescent calibration

device for the instrument used in identification (ID) and minimum

inhibitory concentration (MIC) determination for bacteria, resulting in

cost savings of $100,000 annually.

o Managed projects for the development, validation and implementation of

analytical methods (HPLC and CE) for enzyme substrates and drugs

(antibiotics) to improve and streamline the manufacturing process under

GMP.

o Developed and implemented methods (SOPs) for establishing the shelf-life

and in-process specifications for raw materials, enzyme substrates,

carbohydrates and drugs (antibiotics) resulting in cost saving in

manufacturing.

o Audited vendors providing raw materials for manufacturing of products.

Established vendor qualification processes for all incoming raw materials

and reagents.

o Directed and established a start-up new chemistry laboratory for

synthesis of fluorogenic substrates (peptides and glycosides) under

budget and transferred processes to manufacturing meeting GMP compliance.

o Developed and improved the scale-up and manufacturing processes for the

fluorogenic substrates utilizing GMP/GLP, resulting in cost savings of

$400,000 annually. Trained and supervised laboratory personnel.

o Developed and implemented equipment qualification (IQ, OQ and PQ) for

analytical instruments in technical manufacturing.

o Developed, validated and implemented HPLC methods (QA/QC protocols) for

monitoring quality of raw materials, fluorogenic substrates and drugs

(antibiotics) in manufacturing resulting in 70% reduction in analysis

time.

o Participated in FDA audit for diagnostics laboratory and provided

documents for review.

EDUCATION

ASQ-Certified Quality Auditor (CQA): ASQ-CQA certification.

Postdoctoral Fellow, University of California, Davis, California.

Ph.D., Organic Chemistry, University of British Columbia, Vancouver,

British Columbia, Canada.

M.Sc., Chemistry, Laurentian University, Sudbury, Ontario, Canada.

PROFESSIONAL TRAINING

ASQ-CQA (Certified Quality Auditor); Project Management; GMP and GLP; Lead

auditor's training; Excellence in Leadership; QFD/QLP; Dale Carnegie

Management Course; Government contracts, procurement and management

training; Cost reimbursement training for cost management under Government

contracts; Biospecimen Inventory and Management training; Export Compliance

Training; Karras Effective Negotiation; Six Sigma Foundation Training.

Hazardous Waste Management; Hazardous Material Packaging and Shipping

certification and RCRA. Capillary Electrophoresis; Leadership Skills;

Selection Interviewing; Presentation Skills; Effective Meeting; Kepner-

Tregoe Problem Solving and Decision Making; ACS training on Leading Change;

BioReliance Genotoxicity and Carcinogenicity Workshops.

HONORS/AWARDS

Editorial Board Member for ISBER official Journal: "Biopreservation and

Biobanking

American Medical Laboratory, Inc. Quality Award.

Project Champion Award from the President of Baxter Diagnostics, MicroScan

Division.

Laurentian University Bursary Award for Research from Director of Graduate

School.

Government of India Education Award to Travel Abroad; Research Fellowship

from National Council of Scientific and Industrial Research.

Agra University, Agra Bursary Award for Academic Excellence.

AFFILIATIONS

Member, American Society for Quality (ASQ).

Voice of Customer Chair for American Society for Quality (ASQ), Northern

Virginia section (ASQ0511).

Member, International Society for Biological and Environmental Repositories

(ISBER).

Member, National Capital Chapter of Alliance of Hazardous Materials

Professionals (NCCAHMP).

Member, American Chemical Society.

Member, Separations Science Society.

REFERENCES: Available upon request.

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