SOMBATH (SAM) TIM

CORE COMPETENCY

Method Development/Method Validation

Laboratory/HPLC/GC Analysis

Prepare Budget&Procurement

FDA 483/Warning Letter Remediation

Team Building & Track Leadership

Audit/Compliance/Stability

Equipment Qualification/Metrology

Business Process Improvement

Coaching/Training/Sampling

29 Years Experience in QA/QC/Regulatory

Investigation/CAPA Management

cGMP/ICH/DEA/FDA/EP

Proficient in Quality Management System

ISO13485, ISO14791

21 CFR210-211, 21 CFR 820

PROFESSIONAL EXPERIENCE.

The Ritedose Corporation, Columbia, SC August 2017 – Present

Manager, Quality Control Chemistry

The Ritedose Corporation is aseptic sterile FDA approved GMP facilities. The Ritedose Corp., a world class, specializes in manufacturing inhalation products, eye drops, ear drops and unit dose oral liquids, with expertise in blow-fill seal (BFS) technology. It has an annual capacity of over 1.7 billion doses of asthma inhalation and ophthalmic solutions in a filling range of 0.2mL to 15mL.

Key Contributions / Accomplishments

Implements a paperless system for LabWare LIMS and Empowers to enhance compliance and laboratory efficiency. Implement LIMS for Stability Studies to move from Excel to LIMS for efficiency, compliance.

Improve training program and collaboratively work with Training Group to certify chemists via internal and external courses, and streamline product testing modules.

Support FDA Audit with no 483. FDA complimented, invited for participating as FDA training campus.

Manages 15 Chemists, who are responsible for testing in-process, critical utilities (Water for Injectable, Steam, Nitrogen, Compressed Air), Finished Products, Stability, Raw Materials and packaging componentry.

Manage stability program, studies per site procedures to comply with ICH/WHO and other stability guideline. Review, approve protocols, reports, investigation, and communicate product trending results to QA, customers, and support regulatory filings.

Responsible for testing and release API, and excipients per cUSP/NF, EP to support batch formulations.

Responsible for providing strategic leadership, management and direction to the Quality unit (e.g., GMP, GLP) of the company and for ensuring that Sr. Management is kept aware of critical issues in the areas of responsibility.

Mentors, coaches, and challenges staff in building a cohesive culture of taking ownership and accountability, and for fastening stability and retention of staff.

Improves processes and streamline testing through matrix system, and LIMS automation.

Subject Matter Expert in site Quality, Stability, Validation, LIMS, Empowers, and Sub-Administrator.

Dentsply Sirona (CAULK), Milford, DE April 2013 – July 2017

Manager, Quality

Milford is a largest division of DENTSPLY SIRONA manufacturing medical devices and pharmaceutical products (Restorative composite, Cements, Alloy, Crown Form, Enhance, Poly Vinyl and Acrylic impressive and denture materials, fluoride pastes, Gels and Rinses, Anesthetic Gels, Buckley, Dry Socket). Responsible for management and oversight of Quality Operations and activities.

Key Contributions / Accomplishments

Responsible for providing strategic leadership, management and direction to the quality unit (e.g., GMP, GLP) of the company and for ensuring that Sr. Management is kept aware of critical issues in the areas of responsibility.

Oversaw operations of the Quality Unit related to testing and release of products in accordance with all SOPs, cGMPs, company policies and procedures, and FDA requirements related to the Company products.

Managed physical and analytical laboratories responsible for sampling and testing of raw materials, bulk/intermediate materials, in-process bulk, finished products, stability, complaint, and water samples.

Responsible for testing and release API, and excipients per cUSP/NF, EP to support batch formulations.

Managed site Stability Program per site procedure, ICH/WHO and other stability guideline.

Implemented LabWare LIMS Site Stability Program for both pharmaceutical products and medical devices, from Excel to LIMS for better track, efficiency, compliance.

Implemented new training program. Increased staff competency, developed staffs for career progression.

Implemented LabWare LIMS Investigation. Improved track and trend of the lab out of specification.

Implemented CAPA to reduce complaint testing flow and backlog.

Oversaw Quality Engineering functions including vendor audit and supplier qualification program, review and approve validation activities, test methods and equipment validation, raw materials, product specifications, supplier qualification management and audit, risk management, Non-Conformance (NCN) disposition, CAPA management.

Managed lab metrology, calibration activities using ProCal, CAPA using SmartCAPA, NCN using SmartNC, lab investigations using Labware LIMS, lab equipment IQ/OQ/PQ.

Reviewed, approved procedures, change controls, non-conformance, reworks, stability reports, annual product review, protocols and reports of method transfer, technical transfer, and all validation activities.

Provided technical expertise to develop analytical method validation using HPLC, UPLC, GC, UV/Vis.

Participated in regulatory audits, agency inspections and the site internal auditing program, design control.

Performed risk assessment gaps for ISO and FDA regulatory requirements.

Supported of Regulatory Submissions 510ks, Submission of Device Master File to FDA.

Interacted with other business units and other Dentsply sites to address issues affecting the laboratory.

Conducted performance reviews, implements Employee Development Plans, and career path objectives with direct reports. Manages laboratory budgets.

Assured laboratory personnel are qualified through proper training on appropriate departmental and site SOPs, training modules, cGMPs, GLP, regulations, etc.

Participated in War Room activities, supported internal, corporate, US FDA, Korean FDA, Japanese JPAL, Brazilian ANVISA, Australian Therapeutic Goods Administration, Health Canada audits and inspections.

Reviewed and approved all manufacturing deviations and change control documents, non-conformance.

Managed, reviewed, and finalized the completion of inspections and audits to ensure compliance with cGMPs, SOPs, company practices procedures and governmental regulations with department managers.

Prepared and managed the department budget, evaluated new equipment and other capital expenditures and submits purchase recommendations.

Accupac Inc. Mainland, PA Aug 2012 – March 2013

Manager, Quality Control Chemistry, Microbiology

Responsible for management and oversight of QC Laboratory activities that supported cGMP of OTC products.

Key Contributions / Accomplishments

Managed daily activities of 25 full time staffs, three shifts analytical laboratories, and two shifts microbiological laboratory that supported testing of raw materials and bulk materials sampling and testing, in-process bulk, finished products, stability, complaint, environmental, and water samples, and managed metrology, calibration activities.

Managed site Stability Program per site procedure, ICH/WHO and other stability guideline.

Responsible for testing and release API, and excipients per cUSP/NF, EP to support batch formulations.

Managed in-coming raw material and components sampling, testing and releasing.

Promoted two supervisors for second and third shift to ensure supervision, accountability in each shift.

Implemented training modules to qualify staff. Improved compliance, increased productivity.

Reviewed, approved protocols and reports of stability, method transfer, technical transfer, all validation activities.

Mentored, trained and developed staffs for career progression and continuous learning.

Provided technical expertise for resolutions of lab operations, Laboratory Investigation, Manufacturing Investigation, deviations, change control, CAPA.

Participated in regulatory audits, agency FDA inspections and the site internal auditing program.

Closely managed projects and communicated with internal and external customers to ensure the customers’ project timelines were met per contract agreements.

Tri Tech Laboratories, Lynchburg, VA Jul 2010 – Jul 2012

Manager, Quality (Quality Control Chemistry, Microbiology/Quality Assurance Document Control)

Responsible for management and oversight of cGMP, FDA regulated QC Laboratory Operations and activities of all QC/QA functions.

Key Contributions / Accomplishments

Implemented Lab worksheet system which increased efficiency by 30%. Testing backlog was significantly reduced by 50%.

Implemented new training program to develop staffs on HPLC, GC, lab equipment for career development.

Managed daily activities of 25 full time staffs three shifts analytical laboratory, and two shifts microbiology laboratory that supported sampling, testing, and releasing of in-coming raw materials, components, bulk chemicals, in-process bulks, finished products, stability, environmental monitoring and microbial testing, and water samples.

Managed site Stability Program per site procedure, ICH/WHO and other stability guideline.

Responsible for testing and release API, and excipients per cUSP/NF, EP to support batch formulations.

Implemented quality management system to enhance compliance and to bring the site to pharmaceutical and cosmetic standards. Gained more business from customers as such Proctor & Gamble, GoJo, J&J.

Managed Quality Assurance teams that responsible for calibration, method transfer, Document Control, Batch Records Review and Finished Products Release via SAP ERP system, CAPA Management, Deviation Process, Change Control Process, Plant and Supplier Audit.

Provided technical expertise for resolutions of lab operations, OOS, deviations, change control, CAPA.

Closely managed projects and communicated with internal and external customers to ensure the customers’ project timelines were met per contract agreements.

Participated and hosted the internal and external customer, FDA audit activities.

Pharmaceuticals Consultant Dec 2009 - Jul 2010

Sandoz Inc., Wilson, NC Sept 2008 - Dec 2009

Manager, Quality Analytical Technical Services

Recruited as a remediation member of the site quality management team in response to the FDA 483 observations and the Warning Letter in August 2008. Responsible for compliance and quality systems for the site. Owned and remediated three systems: Analytical Method Validation, Lab Equipment Qualification and Computer Validation, Metrology/Calibration. Remediated and resolved non-compliance, the Warning Letter, the FDA 483, regulatory issues as planned schedule in 2009. Supported the site leadership FDA audit activities, re-inspection and approval.

Key Contributions / Accomplishments

Implemented site Analytical Test Method Cleaning Validation to support site Cleaning Validation program.

Implemented site Stability Program. Managed site Stability Program per site procedure, ICH/WHO and other stability guideline. Qualified, validated site stability walk-in, reach-in stability chambers.

Re-validated, upgraded equipment standalone computer systems: (HPLC, GC, UV/Vis, FTIR, Malvern, Titration, Jet Sieve, Dissolution App) and computer system to comply with 21 CFR Part 11 requirements, per GxP, and to remediate the FDA observations.

Managed a team of Sr. Chemists, consultants, validation/qualification functions in QC. Responsible for method transfer, analytical methods development and validation for commercial generic oral solid dosage drugs API/bulk/finished (dissolution, assay, CU, related compounds, residual solvents, CV/PV validation), lab automation, lab metrology (calibration/maintenance), lab equipment and stability chambers qualification per ICH, USP, lab computer validation, Empower, Lab Data Support and Lab Equipment Procurement per QC budget.

Managed data acquisition system (Empower), and LIMS Administrator.

Provided guidance resolution for Laboratory Investigation, Manufacturing Investigation, Deviations, Change Control management, CAPA to meet FDA requirements.

Provided technical expertise, executed established Novartis policies. Supervised the development and validation of Analytical Test Methods, technical transfer; supported the site cleaning validation program.

Collaborated with Analytical Research Development (ARD), Product Development (PD) to develop drugs, and Regulatory Affairs (RA) to respond to FDA deficiency letters for NDA, ANDA submission, filings.

Collaborated with ARD, RA, PD, and Technical Services in designing validation protocols for dissolution extended release profiles per SUPAC to study the multi-unit particulate coating technology of Eudragit based system. This project was to respond to the FDA 483 observation for release product base on a moving target.

Collaborated with QA/Regulatory Compliance teams in revising 200 plus site procedures to be in compliance with the Global Novartis policies and Quantic Consulting Remediation Strategies.

Sr. Supervisor, Wyeth Pharmaceuticals, Richmond, VA October 1990 - Sept 2008

Key Contributions / Accomplishments

QC Project Management, Budget Management, Automation Technology, Analytical Development

Developed and validated analytical methods. Consolidated analytical methods to improve lab efficiency.

Validated test methods per master validation plan. Participated in Global audit, FDA inspections readiness.

Validated, implemented Zymark Prelude Automated Workstation for sample preparation.

Wyeth Team member of Process Analytical Technology, and Quality by Design project.

Developed, validated, implemented GE Ion Trap Mobility Spectrometry technology as alternate analytical cleaning validation methods to HPLC methods. Reduced cost and increased support output to Operations.

Developed, validated analytical testing methods utilized HPLC, UPLC, GC, UV/Vis, to support Preparation H, Chapstick, Dimetapp, Robitussin, Advil product lines.

Prepared, managed annual QC Operation and Capital budget. Replaced new lab equipment. Reduced lab instrument down time. Managed Quality Projects assigned by Sr. Director of Quality Operations.

Quality Sample Management Group

Implemented Sample Management Group to track sample custody including stability samples. Remediated compliance gaps, and improved testing cycle time. Awarded by Wyeth Leadership for best practice for Material Availability Improvement project.

Responsible for testing and release API, and excipients per cUSP/NF, EP to support batch formulations.

Responsible for testing and release components per the site procedures to support packaging production

Quality Control Respiratory Laboratory

Responsible for supervising the day-to-day of cGMP, FDA regulated analytical testing laboratory with respect to testing (for cleaning validation, process validation, in-process/bulk, finished products, stability, complaint, critical utility), reviewing, approving and releasing analytical lab data for Rx Solid Dosage forms (Tenex, Reglan, Quinidex, Donnatal, Ismo) all respiratory products disposition (Robitussin, Dimetapp, Advil, Primatene Mist), and maintaining laboratory compliance with regulatory agencies.

Led QC team to audit laboratories in preparation for the internal and global audits; interacted with FDA inspectors. Collaborated with RA, QA Audit Compliance to improve compliance and quality systems.

Implemented a training curriculum, product-training modules, and chemist certification program.

Led LACES project (Lab Automation Compliance Enhancement Systems), Waters Empower, LabWare LIMS implementation Wyeth Paperless Computer System Waters project.

Participated and hosted the internal and external audit activities.

Technical Services Scientist

Responsible for managing the plant manufacturing and packaging equipment qualification and supporting process validation and cleaning validation activities for Oral Rx Solid Dosage (Donnatal, Quinidex, Tenex, Reglan, ISMO20, Micro K) forms, Liquids (Advil, Robitussin, Dimetapp) and Topicals (Chapstick, Preparation H) forms.

Established, implemented and improved plant manufacturing and packaging equipment qualification program to enhance compliance per site Equipment Master Validation Plan.

Spearheaded the validation of critical utilities (HVAC, Compressed Air, USP Water, Electrical, Steam).

Assisted in implementing site cleaning validation program to support productions and enhance compliance.

Supported process validation of new product launches, technology transfer, and existing products.

Authored, executed IQ/OQ/PQ, cleaning validation, and process validation protocols and reports.

Worked with Product Formulation, and Plant Operations for new and improved technology, new products.

Chemist I, II, III, Lead

Tested A.H Robins, Wyeth, Wyeth-Ayerst (solid, liquid, simi-solid, and injectable) consumer and Rx pharmaceuticals products using most laboratory instruments (HPLC, GC, UV/Vis, FTIR,AA, ICP, Dissolution Apparatus listed in Technical Proficient Skills).

EDUCATION

M.B.A, Virginia Commonwealth University, Richmond, Virginia

B.S. Chemistry, Virginia Commonwealth University, Richmond, Virginia

Chemical Engineering Technology, Centennial College, Toronto, Ontario, Canada

Certificate of Project Management, University of Virginia, Charlottesville, Virginia

TECHNICAL PROFICIENT SKILLS

Enterprise Systems: Beckman LIMS, SQL*LIMS, LabWare LIMS, Waters Empower, PeakPro, Agilent ChemStation, SAP, Trackwise, GxPharma, IsoTrain, Edge Training, LMS, Blue Mountain Calibration Manager, ProCal Manager, SmartSolve, SmartCAPA, SmartNonConformance, Master Control, e-Time, Paycom.

Office: Word, Access, Excel, Visio, Power Point, Project, Lotus Notice, GroupWise, Microsoft Outlook, Minitab.

Analytical Techniques: Expertise including hand on for Wet Chemistry, HPLC, UPLC, GC, UV/VIS, NIR, Raman, AA, FTIR, TLC, USP Dissolution Apparatuses (I, II, III), Automation, Malvern Particle Analyzer, Karl Fischer, Ion Trap Mobility (ITMS), Titrator. Trained on LC/MS, ICP.

Test Method Development and Validation: Assay, Dissolution, Cleaning Validation, Residual Solvent, Limit Test per ICH and USP/NF, BP. USP test method verification and Cross over validation to USP.

Process Improvement: 5S, LEAN, DMAIC, Six Sigma Green/Black Belt methodology, project management. Audit/Compliance: Auditor/Compliance Specialist. US FDA, Japan PMDA, Korean FDA, Japanese JPAL, Brazilian ANVISA, Australian Therapeutic Goods Administration, Health Canada, EU.

Leadership: Mentorship, Team Building/Leadership, Supervisor/Manager training, Risk Management.

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