SUMMARY:

• Extraordinary Ability Scientist Recognized by USCIS, US Citizen
• High achiever research scientist with lots of publications and presentations
• Solid comprehensive noledge and 13 years hands - on experience in teh areas of R&D, formulations, Aseptic Processing , validation, scale up, QA, QC in biotech, pharmaceutical, medical device & clinical industry
• 6 years management experience (QC/QA, R esearch & D evelopment)
• Abundant experience in Medical Device , Sterile , aseptic , vaccination
• Familiar with ISO/GMP/ICH/USP/EP/ SDS/OSHA/USDA/FDA/MDR/MDSAP/RAC /EMEA /CMC/ 21CFR /Haz-Mat/ISO 13485, and strong analytic method development
• Rich experience on handling audits, complains, continues improvement & root cause analysis
• Familiar with Business Intelligence and Data analytic tools, Tableau, Spotfire, SAS, Python
• Strong troubleshooting and problem solving skills
• Strong computer, mathematical, statistics, finance and physics capabilities
• Dedicated, self-motivated and innovative individual with excellent integrity
• Excellent oral and written communication skills with multi-lingual ability
• Experienced in team based projects and an easy going person
• Be able to handle multi-tasks and prioritize tasks, adapt rapidly to new projects
• Willing to work overtime and weekends, available for heavy travel schedule
• Ability to work a flexible schedule to support a 24/7 facility

PROFESSIONAL EXPERIENCE:

Confidential, Brooklyn, NY

Quality Control Supervisor

Responsibilities:

• Managing and implementing teh plant Quality Management System according to corporate directives and expectations
• Anticipates and responds to regulatory agency requirements and reports related to food safety.
• Makes collaborative food safety and quality decisions regarding ingredient, raw product, in-process product and finished product conformance as designated by teh QA Manager.
• P erform chemical and physical analyses and tests
• Assists with plant internal audit functions and activities in order to be audit-ready.
• Handle Customer Complaints and returns
• Analysis data with Tableau, Spotfire, SAS, Python
• Member of teh facility Food Safety Team, develops Hazard Analyses, HACCP/Preventive Control plans, and assures compliance with HACCP, FSMA and all regulatory requirements.
• Manages sample retention and evaluation program.
• Publishes regular and ad hoc reports on key Quality and Food Safety metrics. Analyzes data for process improvement opportunities.
• Facilitates investigation and corrective actions in response to customer and consumer product quality and food safety-related questions and complaints. Assists with related corrective action plans and implementation as necessary.
• Provides training to QA technicians, as well as other members of teh plant team.
• Looks for opportunities to reduce system cost as appropriate.
• Assures that any issues are addressed and corrected in a timely manner.

Independent Consultant

Confidential

Responsibilities:

• Worked with teh executives of over 10 corporations in teh two and half years in order to improve success.
• Introduced teh U.S.A. management and technical standard to foreign companies
• Handled Customer Complaints and returns
• Analyse data with Tableau, Spotfire, SAS, Python
• P erform ed chemical and physical analyses and tests
• Ensured cGMP compliance in teh plant, introduce ICH/USP/EP/CMC/ISO 13485 guideline, get and renew cGMP certificate and ISO certificate, offer EHS training
• Validat e d teh SOP and instruments(HPLC/UPLC/GC/GC-MS/MS)
• Ran SAP QA analysis(OTC)
• Validat e d teh SOP and instruments
• Launch ed Sterile Products and Medical Device s
• Built non GMP development stability facility, manage sample pull and protocol in stability LIMS, ensure EHS compliance
• S upport ed Clinical Trial Data Sharing and Publication of Patient Lay Summaries
• Help ed to w rite and review relevant regulatory submission documents for IND and NDA filing
• Wro te scientific documents that comply with applicable laws, regulations, and are used to appropriately respond to inquiries from payers and Health Care Providers
• Set a strong communication interface between all departments to improve efficiency and service
• Developed dynamic business plans to reinvigorate operations.
• Evaluated and appraised project design, overseeing execution to keep it on track.
• Identified areas of potential improvement, submitting a report of inefficiencies and strategies for betterment.

Confidential, Bridgewater, NJ

QC Manager & Q A Scientis

Responsibilities:

• Oversee n, manage d and facilitate d teh workloads of teh laboratory to meet company expectations.
• P erform ed chemical and physical analyses and tests
• Serve d as technical advis e r for laboratory staff.
• Responsible for supervision and training of laboratory staff.
• Perform ed routine statistical analysis for quality control data and establishing trends
• Analyse data with Tableau, Spotfire, SAS, Python
• Handled customer complaints and returns, ran root cause analysis and wrote teh report
• Lead stability tests and managed LIMS system
• Gap analysis & equipment validation, calibration and correction
• D eveloped, edited and managed teh scientific PowerPoint slide presentations for customers as teh primary audience
• Manage d teh ISO 9001 quality registration process and GMP audit & training in teh plant
• Ensure d CAPA commitments are adequate, submitted and completed in a timely manner
• P repar e d of teh Annual Product Review Reports
• Oversee n all analytical and microbiological testing of incoming raw materials, in-process samples, bulk substances, final product and stability samples.
• Serve d as a strong communication interface between all departments for all QC related issues
• P erformed testing, as necessary, according to SOP’s, compendia or others methods on laboratory samples.
• Applied Lean Manufacturing Principles, KAIZEN, 5S, in teh plant
• Assured teh laboratory operates in a compliant manner consistent with cGMP’s, Quality Management Systems as defined in company programs and policies.
• Implemented and managed method development and validation for Quality Control test methods or lab equipment, including preparation, review and approval of Protocols and Summary Reports.
• Ensured OOS events are adequately investigated and resolved in a timely manner.
• Managed teh retain and stability program for all applicable products.
• Managed analytical and qualitative reference standard libraries, including identifying appropriate standards and monitoring storage, inventory, expiration.
• Maintained an active role on continuous improvement teams to identify opportunities to increase efficiency and TEMPeffectiveness, and reduce costs (e.g., scheduling efficiencies, out-sourced testing, and supplies).
• Wro te and reviewed Investigations, Protocols and Summary Reports
• Responsible for lab personnel functions including interviewing, work and vacation scheduling.

Confidential, Hampton, IA

Quality Assurance Supervisor

Responsibilities:

• Responsible for teh QC/QA laboratory operations at teh Hampton, IA manufacturing plant with 60 employees and about 30 different product chemicals packaged into about 210 Finished Product SKU's
• Managed teh Quality Control/Quality Assurance systems and laboratory to provide accurate and timely analytical support to production teams in order to meet finished product specifications, minimize any potential environmental impact, and to assure profitability of teh Hampton plant
• Figured out teh solutions for shelf-stable produce and thermal processed product
• P erform ed chemical and physical analyses and tests
• Managed CMO , third party , Contract manufacturing and external manufacturin g
• Lead stability tests and managed LIMS system
• P repar ed of teh Annual Product Review Reports
• Built Sharepoints IntraNet, Continuous Improvement and Root Cause analysis Systems. Be an integral part of teh overall OMNIUM Technical Services QC/QA development team to ensure Quality system requirements are being developed and met
• Handled customers complaints and 3rd party audits of suppliers for compliance with regulations
• Analyse data with Tableau, Spotfire, SAS, Python
• Contributed to teh cost reduction projects

Confidential, Paterson, NJ

Chemist

Responsibilities:

• Devised research & processing solutions related to product lines of flavor & fragrance ingredients.
• Performed reaction vessels to move from teh lab through teh pilot plant tan to full scale production by using modern instruments (GC, MS, UV-vis, FPLC and HPLC etc) and structural identification techniques (GC/MS, LC/MS, FTIR, NMR and computational programs), developed and modified processes to safely deliver performance and aesthetics in scale-up to manufacturing
• Conducted CMO , third party , Contract manufacturing and external manufacturin g
• P repar ed of teh Annual Product Review Reports
• Complied with teh reporting of adverse TEMPeffects and product complaints
• Provided a comprehensive evaluation of existing experimental techniques on dozens of synthesis routes and demonstrating teh necessity for developing technology in new directions.
• Quality Control & Quality Assurance of teh flavor & fragrance products, performed Continuous Improvement and Root Cause analysis, participated teh government and customer audits
• Defined raw material sources and specifications to be used by teh company

Confidential, Hattierburg, MS

Lab Manager & Research Associate

Responsibilities:

• Managed all Aspects of teh Research Lab involving Reagents, Equipment and Ordering
• Designed and Implemented Adhesive Change of Pressure Sensitive Adhesive (PSA) System After White Light Irradiation by Texture Analysis
• Collaborated Kinetic, Mechanical and Conductive Analysis of Thiol-Ene Coatings Containing Gold Nanoparticles and Examination of Thiol Reactivity After UV Irradiation
• Compared teh Chemical Reactivity of C70 and Sc3N@C80 Using Cycloaddition Chemistry by HPLC Analysis
• Coordinated Higher-Order Adduct Formation in Functionalized Metallic Nitride Fullerenes by HPLC Analysis

Confidential, Hattierburg, MS

I ndependent Teaching Assistant and R esearch A ssistant

Responsibilities:

• Supervised 400 Level Lab of Analytic Chemistry
• Tutored College Student in Chemistry and Biochemistry Major
• Completed Purification and Analysis of Hydrophobic Protein Sc3 from Aqueous Media by LC, Electrophoresis, Silver Stain and Western Blot
• Established Synthesis of Nanosized Polymeric-Micelle-Thiomers as Oral Drug Delivery Vehicles by Reversible Addition Fragmentation Chain Transfer (RAFT)
• Analyzed Computational Models of Organic, Inorganic and Biochemical Compounds (Energy, Structure, …)

Confidential Norfolk, VA

Responsibilities:

• Developed Real-time Study of teh Mechanism of Chromosomes Replication of Bacteria Pseudomonas aeruginosa by Single Live Cell Microscopy Imaging Analysis
• Used Laptop Computer to Record and Analyze data in Microsoft Word and Excel Based Files

TECHNICAL SKILLS:

Regulation: Knowledge of ISO, ICH, USP, EP, GFSI, GLP, Good Clinical Practices (GCP), ASCP, Good Engineering Practices (GEPs), Good Agricultural Practices (GAPs) and Good Harvesting Practices (GHPs), FDA and EU (MDR) medical device regulatory requirements , Medical Device Single Audit Program (MDSAP) , Regulatory Affairs Certification (RAC) , Process Safety Management (PSM), Process Hazard Analysis (PHA), HazOp, LOPA (Layers of Protection Analysis), FEMA, PHA, Change Control Requests (CCRs), Change Control Review Board (CCRB), 21 CFR P11, Statistical Process Control (SPC), User Requirement Specifications (URS), Design Qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), cleaning validation and process validation, Critical Quality Attributes (CQAs), International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), United States Pharmacopeia (USP), Document Control Systems (DCS), Programmable Logic Control (PLC), design of experiments (DOE), CMP (Chemical Mechanical Planarization), HACCP( Hazard analysis and critical control points), BRC, FSSC 22000, OTC, Micro, SOPs, GMPs, cGMP, CAPAs, SOPs, APIs, OSHA, RCRA, DOT, EPA, OPPTS, OECD, MHRA, DMAIC(Define, Measure, Analyze, Improve and Control) Process, DFSS(Design for Six Sigma), Sanitary design principles, CI/IL6S, Meridian, Lean, metrology, sampling procedures, FDA, EMA, JFDA and EU regulatory and guidelines.