Sr. Chemist or Equipment Validation Specialist

Arnold K. Lin

** *** ****** **, *******, NJ, ****3

Cell: 732-***-**** Email: **********@***.***

Objective To obtain a rewarding position in pharmaceutical / cosmetic / chemical manufacturing plant as a laboratory Equipment Validation specialist or Senior chemist or supervisor. Areas of Knowledge

Work Experience

FDA regulations & GMP, OSHA rules and MSDS, Product R&D, Laboratory Testing, Q.C. & Equipment Validation, and strong background of instrumentation, USP, FCC, NF test methods.

Jan 2022 – Current

Innovative Pharma Solutions, Inc. (IPS)

269 Great Valley Parkway, Malvern, PA 19355 Tel: 267-***-**** Equipment Validation Specialist

Responsibilities and projects included:

• Work with the laboratory manager together to build a new chemical/biological laboratory.

• Install, Set-Up and validate varies new and used instruments for laboratory operation. Jun 2020 – Jan 2022

IPS/Janssen Pharmaceuticals of Johnson & Johnson

1125 Trenton Harbourton Rd, Titusville, NJ 08560 Tel: 267-***-**** Equipment Validation Specialist

Lab Equipment Validation:

• Provide project management and technical support for monitoring the existing Lab instruments and computerized systems of Pharmaceutical Analytical Quality Labs and maintain acceptable levels of performance, reliability, user satisfaction and integration with other enterprise systems.

• Author and review validation documents, Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications.

• Work closely with IT to support ongoing instrument and applications troubleshooting, maintenance, retirement and change management efforts in a timely manner.

• Work closely with Equipment vendors to support instrument maintenance and updates.

• Maintain familiarity with cGMPs, CFR Part 11, Annex 11, Analytical Instrumentation Qualification (AIQ) SOP, data integrity best practices and current regulatory guidelines related to instrument calibration and computer systems validation.

• Ensure compliance with all work instructions and standard operating procedures relevant to laboratory instrument and computer systems.

• Create and approve WI, SOP’s and forms that support laboratory instruments and data management systems.

• Support internal and external audits of Laboratory Instruments and associated computerized systems.

Instrument Decommissioning:

• Provide decommissioning support for Lab instruments and associated computerized systems.

• Develop guidelines and implementation of work plans for proper GMP execution of laboratory instrument decommission phases.

• Maintain familiarity with cGMPs, CFR Part 11, Annex 11, Analytical Instrumentation Qualification (AIQ) SOP, data integrity best practices and current regulatory guidelines.

• Drive initiatives from requirements determination to project closure.

• Manage project interactions and dependencies; provides project reporting and governance, and issue and risk escalation management.

• Ensure the consistency of project delivery practices resulting in high customer satisfaction levels.

• Conduct proper research and incorporates industry best practices as appropriate.

• Manage and allocate resources to project managers across the IT organization.

• Track and report high-level project status. Identify and help projects in troubleshoot delays.

• Monitor and communicate the progress of project delivery and ensure timely and effective communication of project status in terms of cost, forecast, schedule, and assessment of risk/issues or concerns.

• Conduct project post-mortems and create recommendations reports in order to identify successful and unsuccessful project elements.

Jan. 2017 – Jun. 2020

PARDS Research

211 Warren Street, Newark NJ 07103 Tel: 973-***-**** Senior Chemist / Laboratory Manager

Duties included:

• Manage regulatory correspondence and compliance to FDA, EPA, DEA and corresponding state agencies.

• Perform IQ/OQ/PQ and calibration of instruments.

• Supervised and created Stability Protocols per customer needs.

• Write and review protocols, SOPs, Methods.

• Manage day-to-day laboratory activities.

• Review notebooks and logbooks and ensure compliance to SOPs and SPIs including compendial methods.

• Provide technical training and retraining to new and existing chemists. Apr. 1997 – November 2016

Colgate-Palmolive Company

191 E. Hanover Ave. Morristown, NJ 07962 Tel: 973-***-**** Sr. Chemist

• Responsible for leading a team of lab chemists and ensuring all day-to-day manufacturing tasks were completed in a timely and precise manor.

• Remained current in industry standards such as GMP, GLP, and all OSHA requirements.

• Provided training to new lab chemists for analytical testing.

• Coordinated with laboratory instrument service contracts and calibration.

• Coordinated with technology transfers from R&D department to quality control department.

• Experienced in writing OOS/LIR, SOP/SPI, and CAPA.

• Performed the IQ/OQ/PQ of laboratory equipment.

• Mentored other chemists in troubleshooting hardware and software issues.

• Experienced in all areas of wet-chemistry and instrumentation chemistry including, but not limited to, raw material testing, in-process samples and finished product testing.

• Experienced in product development in formulation and reformulation.

• Experienced in test method validation.

• Lead the integration with the on-line NIR automated testing system, removing potential failure points and drastically reducing costs.

• Participated with pilot plant engineers to scale up manufacturing batches.

• Participated in annual product (quality) reviews in order to identify site-wide process improvements.

• Participated in worldwide quality audit teams of vendor's raw materials.

• Ordered and maintained chemical inventory for the entire laboratory. Duties included:

• Supervising 3 to 6 direct reports (chemists) in a cGMP/QC-like laboratory for the analysis of raw materials, in-processing samples, finished samples, stability samples and consumer complaint samples.

• Ensured the timely and compliant calibration of laboratory instruments as well as troubleshooting, routine maintenance and reviewed/approved service contracts.

• Managed the day-to-day activities of the chemistry laboratory to include input for time management to ensure on-time analysis and release of results to clients as well as method development, transfer and validation as necessary.

• Quantitative analyzed raw materials with HPLC, GC and AA spectroscopy by using USP methods. Quantitative analyzed in-process, finished, stability samples and consumer complaint samples for OTC and non-OTC products with HPLC, GC and AA spectroscopy by using in-house validated methods.

• Performed and analyzed raw materials, in-process and finished products moisture contents by Karl Fischer.

• Quantitative analyzed raw materials, in-process and finished products by using NIR Analyzer.

• Performed FTIR and FT-Raman scans for raw materials to Identify and determine materials' qualification.

• Operated Autotitrators to analysis raw materials, in-process and finished products in various testing.

• Created, modified and run all automatic sequences for HPLC, GC, AA spectroscopy and autotitrators, etc. instruments. Review, reprocessing and approve sequences and results.

• Operated CEM Microwave-Oven and conventional oven to determine all materials solids/moisture contents.

• Assigned daily tasks for individual chemists in the shift.

• Performed instruments calibration, reagents, standards preparation and data reviewing.

• Conduct bench batch adjustments of in-process product batches.

• Test and release or block raw materials for manufacturing use.

• Performed wet chemistry testing - extractions, titrations, melting points, color comparisons, density, refract index, loss on drying, viscosity, turbidity and pH, etc. Dec. 1986 – Apr.1997

Pharmaceutical Innovations, Inc.

897 Frelinghuysen Ave. Newark, NJ 07114

Tel: 973-***-****

Sr. Chemist (acted as a Production Manager and QA Manager)

• Created guidelines and standards to meet FDA and OSHA regulations and created QA systems which include, but are not limited to, governing SOP's creation

• Coordinated with company owner to determine software and hardware required to perform all laboratory tasks within the company.

• Coordinated with production manager on product scheduling and planning.

• Laboratory instruments calibration & upgrading.

• Responsible for product research and development, including hands on formulation and established the stability program.

• Introduced state-of-the-art technology to improve efficiency, accuracy, and accountability in quality systems.

• Lead research & development for the creation of three new products, which represents a significant share of overall company revenue.

• Responsible for hiring and training chemists and compounders.

• Participated in starting up ISO 9000 Program.

• Responsible for ordering and negotiating raw materials and laboratory supplies. Duties included:

• Managed 4 to 15 direct reports, including technical employees and non-technical employees in overlapping departments.

• Reviewed and approved validation protocol for manufacturing and process validation as well as stability protocols and reports as submitted by customers and internal Quality.

• Review, revision, authoring and approval of department SOP’s, OOS reports, CAPA and Deviation reports, etc.

• Review and approval of final analytical results for all samples submitted t the laboratory to include stability and final release of raw materials, in-process and finished products.

• Laboratory compliance with strict adherence to cGMP, ISO, FDA and OSHA guidelines.

• Worked along with the Plant Manager to schedule production.

• Negotiated and order raw materials for manufacturing use.

• Using EDXRF instrument to analysis active materials for finished product.

• Performed Rheometer instrument to analysis raw material and finished products.

• Performed Celsis Luminometer to identify bacterial.

• Operated Autoshaker Incubators and Autoclave for microbiological test and sterility products and lab equipment.

• Wet-chemistry testing for raw materials, finished products and stability samples. July – Nov. 1986

A.I Technology, Inc.

88 Stoke Avenue, Trenton City, NJ 08543 Tel: 609-***-**** Chemical Technician

• Batch making for epoxy, sealants, adhesives and electronic coatings.

• Chemical testing.

• Production sampling and sample keeping.

Education

1982 – 1986 State University of New York - Stony Brook B.S. Degree in Engineering Chemistry

SIGMA BETA Honor Society – State University of New York - Stony Brook 1978 – 1981 Guang Zhou Medical College, China

Extension courses in the field of Medical, Biochemistry. Professional

memberships

Member of The American Institute of Chemists.

Member of The American Chemical Society.

Member of National Association of Realtors.

Instrumentation and

Technical Skills

HPLC, AA spectroscopy, UV-VIS Spectrophotometer, FTIR (in line & off line), Near IR, ICP/Optical Emission Spectrometer, XDS and Rapid Liquid Analyzer FOSS NIR, FT-RAMAN, GC, GC-MS, Auto-Titrators, Karl Fischer, Celsis Luminometer, Rheometer, Viscometers, CEM microwave oven, Energy Dispersive X-Ray Fluorescence, Autoshaker Incubators, Microtrac Practical Analyzer, Hunter Lab’s Color Quest analyzer, HIAC Liquid Particle Counter 9703+, Malvern Mastersizer 3000, Sotax Hardness Tester and Autoclave, etc. Advance courses in

instrumentation

HPLC, GC, FTIR, Near IR.

Computer Windows and Microsoft Word, Excel, Access and PowerPoint, DOS, SAP, LabNet, WMS, PIM, Documantum, TotalChrom, ChemStation,Tiamo, Assure-ID, Minitab, Statistical Process Control(SPC) and computer hardware configuration, Shop Floor. Millennium Workstation & Empower 3. Reference

All current and previous employments: colleagues, supervisors and business owner. Available upon request.

Travel

Willing to travel if required by position.

Availability

Any time after 3 weeks’ notice.

Languages

English, Chinese (Mandarin & Cantonese)

Contact this candidate