Jeffrey W. Malson

**** ******** ****** ******** ** 29505

Cell Phone 843-***-****

acrdoh@r.postjobfree.com

QUALIFICATIONS

Experienced Quality Leader with expert knowledge of Analytical Chemistry and Quality Improvement. Over 18 years’ experience providing analytical support to the manufacture of bulk/dosage, diagnostic and medical device production. (10 yrs) process control, (7yrs) final product release, (2yrs) batch record review, (2yrs) Medical Device QA & Product Complaints, (12yrs) QC Management

Proficient at leading lab investigations in compliance with FDA guidelines. Expert understanding of cGMP, and ICH Q7a guidelines. Familiar with requirements for USP testing, DEA, NRC, and EPA regulations.

Trained in Quality Improvement tools such as FMEA, Lean Manufacturing, 5S, Theory of Constraints, Juran 13 Steps, High Performance Work Teams, Cause Mapping, 5-Y’s, SQC, Ishikawa-4M’s&4S’s, Team Facilitation.

Maintain high degree of regulatory compliance in laboratories under my responsibility. No significant findings in numerous audits including those at Roche (3-FDA General, 1-DEA, 4 Corporate) or Mallinckrodt (2-FDA General, 3 FDA-PAI, 2 Corporate).

Demonstrated skill utilizing of computer systems and software including Excel, Access, Calibration Manager, PowerPoint, Trackwise, and SAP.

Experienced Analytical Chemist with more than ten years bench experience performing wet chemical and instrumental analysis. Demonstrated expertise utilizing HPLC-UV,RI,DAD, GC-FID, GCMS, PyGCMS, ECD,TCD, UV-Vis, FT-NIR, FT-IR, TOC, Conductivity, Coulometry, Dissolution Baths, Friability and Hardness Testers, Automated Titrators, Polarimeters, and Particle Size measurement equipment including Malvern, Alpine, and Sympatec Laser Diffraction.

User and super user knowledge of with various chromatographic data acquisition and integration packages including Agilent- (Chemstation/Chemstore/GPC,Open Lab), PE Nelson (Access, Turbochrom), Waters-(Maxima, Empower), Shimadzu-(EZChrom).

Knowledgeable of Lims use and maintenance. Served as department lead on site team responsible for implementation and validation of LIMS system. Provided necessary input required to design, install, and validate Agilent Lims Product within 12 months of project initiation. Directed construction of more than 200 Lims templates needed to existing products under my testing responsibility. Responsible for building and maintaining department Lims templates for new and existing products. Created and supervised creation of library of more than 1000 PSL’s, Specifications and Login configuration since implementation 5 years ago. PSL’s include electronic calculation, method information, and data capture needed to provide statistical process control, resource utilization, and lab KPI reporting. Required extra planning, concept development, and risk caused by project deadlines during implementation. First lab on site to utilize Lims for these purposes

Implemented electronic worksheets utilizing available but, previously unused Lims functionality. Worksheets were serialized, test specific, identified by product, analysis number, an analyst at generation. Responsible for suggesting use of electronic system, and evaluating available software options with IT consult. Recommended and gained Quality approval for system utilized, design test specific worksheets templates, implemented usage. Electronic worksheets used significantly reduce manual recording of header and electronically tie paper reports to unique Lims generated sample identifiers. System improves control over previously used manually generated worksheets and brings lab take one-step closer to being paperless.

Experienced in using on line and at-line Process Analytical Technology including NIR reaction monitoring, reagent make-up, water content, equipment cleaning.

WORK HISTORY

Weylchem, US 2014-2015

Manager Analytical Services (1.5 yrs)

Lead and direct Quality Control, Environmental, and Analytical Development labs for Weylchem, US at Elgin SC site. Provide technical leadership for all lab functions on site. Responsible for QC release, analytical method development, transfer, and environmental monitoring of waste streams. Responsible for department budgeting, training program, and instrument maintenance and calibration programs. Four direct reports including Supervisor and Sr. Scientist level staff members and oversight of performance for group of 12. Rebuilt lab staff after 50% turnover of analysts that took place prior to my joining company. Successfully avoided key interruption to plant service by coaching, utilization of temporaries, and acknowledging staff efforts during rebuild. Successfully completed Environmental Lab Certification with DHEC. Implemented instrument Qualification and Maintenance program.

Kemira 2010-2014

R&D Analytics Manager (4 yrs)

Lead R&D Analytical Team supporting development and technical customer service of new polymers used in Oil & Mining, Paper, and Water Treatment industries. Direct work of analytical team consisting of 7 Scientists performing routine analysis and method development using various analytical techniques HPLC, GPC, IC, ICPMS, GC, GCMS, PyGCMS, HSGC, FTIR, XRF, Wet Chemistry. Responsible for coordinating services of outsourced analytics and acquisition/implementation of new analytical technologies. Responsible for seeking and getting approval for more than $300K of Capital improvements for analytical Team. Eliminated 3-month sample back log with zero increase in staff and 400% increase in sample volume. Made substantial improvements to utilization existing lab but, under-utilized lab equipment such as TGA, Viscotek, and GC. Improved reliability of EPA 24 VOC measurements reducing analytical variation by adding performance check. Introduced three major techniques in 3 years including ICPMS, GCMS, and PyGCMS to improve service to lab customers. Successfully implemented Method Validation program and helped to create global approach to method validation.

Ciba Vision 2010

QC Manager (6-months)

Manage Quality Control Department for major Medical Device Manufacturer. Responsible for Quality System maintenance, recruitment, compliance, and personnel development for three laboratory units including Chemistry, Microbiology, and In-Coming Raw Material inspection. Responsible for leading lab investigations and method validation. Trained in using Trackwise and JMP software.

Roche Carolina Inc. 1998-2010

Quality Lab Manager (5 yrs)

Manage Process Control Analytics Department with responsibility for in-process QC of bulk API’s. Responsible for hiring, training, supervising, and development of lab staff. Responsible for lab Budget, Lab Compliance, Lims, Assignment of SOP and Method Maintenance. Approve and lead OOS Investigations, Transfer, and Validation reports. Obtain approval and justify capital projects and lab Improvements. Assigned as one of 2-site representative to corporate level Process Analytics Cross-functional team. Named as site analytical lead for two separate process transfer teams coordinating with Roche Colorado Corporation, and Roche Basel Technical Development Teams. Completed transfer and qualification of process steps for bulk drug products Valgancyclovir and CETP, which included in-process analytics (PAT), and analytical analysis for intermediate and finished step releases. Serve as team member on various site teams Cleaning Analytics, Relay for Life, Day of Caring, and United Way and Leadership Forum. Supervise 8 direct reports. Reported to Director of Site Quality.

IPC Supervisor (5 yrs)

Successful transfer of more than 15 production steps and 4 Roche commercial product Launches. Served as site analytics lead on transfer team that completed first time joint Roche 3rd Party transfer with Pharmacia and additional third party venture with Nektar. Both involved collaboration and external site visits to complete two separate technical transfers. Author assigned methods and procedures as required for general regulatory compliance. Oversee instrument calibraon and maintenance program. Responsible for assigning shift coverage and vacation scheduling for 24/7 lab operation. Optimize analytical methods, evaluate new technologies, and lead lab investigations. Supervise up to eight analysts; including scientist and technician level. Responsible for management of lab budget. Reporting to Process Optimization Leader in Manufacturing.

Sr. Scientist (2 yrs)

Assist Research Leader in initial set-up of process control laboratory for supporting initial commercial start-up at Roche Florence API production facility. Responsible for training five first time lab technicians in chromatography and wet chemical analysis. Provided consult and significant input to design and implementation of initial lab systems in cGMP compliant lab setting. Responsible for lab instrument calibration and maintenance with more than 20 instrument systems including GC,HPLC, FTIR, UV-Vis, Titrators, TOC. Provide shift support and guidance to lab technicians on shift 24/7. Facility successfully completed launch of two major commercial products (Xeloda and Xenical) within 14 months of start-up utilizing analytical support provided by this lab.

Mallinckrodt Inc. 1986-1998

Quality Section Leader (2 yrs)

Lead team of six including chemists and technicians in the in process and release testing of API and Dosage Pharmaceuticals. Schedule shifts and serve as principal contact to R&D and Manufacturing. Provide annual evaluation of analyst performance. Assure accurate and timely testing of drug products making use of SPC, record review, and method validation. Laboratory supported over 25 products making use of HPLC, GC, UV-Vis, FTIR, and Classical Wet Chemical Techniques.

Quality Control Chemist (5 yrs)

Responsible for release and in process testing of bulk and dosage form narcotics.

Analytical techniques used include HPLC, GC, Dissolution, Hardness, Friability, Wet Chemistry, TLC, UV-Vis, and FTIR. Execute protocols to demonstrate technology transfer and complete ruggedness portion of method validations developed by R&D. Followed cGMP, FDA, DEA, and USP guidelines.

Associate Chemist R&D (3 yrs)

Conduct analytical testing and process development work in support aromatic fluorine intermediates. Primarily HPLC and Wet Chemical analysis. Assisted in the implementation of in-line NIR for monitoring of feed streams. Trained union operators to perform IPC tests. Worked in pilot facility assisting Process Chemists and Engineers in scale-up of synthetic organic processes.

Cyclotron Technician (2 yrs)

Manufactured, isolated and purified desired isotopes. Utilized hot cells, glove boxes, manipulator arms, and electroplating equipment for source compounds. Isotopes produced include thallium, gallium, and indium.

Sherwood Medical 1985- 1986

Senior Technician QA, Sherwood Medical (2 yrs)

Performed medical device inspections and quality audits for Monoject and Argyle product lines. Duties included writing test protocols, developing test methods, and conducting product evaluations. Mostly destructive physical testing for conformance to ANSI, MIL, and ISO standards.

Mallinckrodt Inc. 1981- 1985

Technical Coordinator, Mallinckrodt Inc. (2yrs)

Provided off-shift technical coverage for Niobium/Tantalum Continuous Extraction Process. Interpreted lab results to determine appropriate batch adjustments in acidity and concentration. Trained operators in technical aspects of process. Work as lab analyst performing gravimetric and wet chemical analysis.

Process Technician, Mallinckrodt Inc. (3yrs)

Manufactured and packaged various in-vitro diagnostic, immuno-assay, and radiographic imaging agents. Hands on experience with aseptic filling, lypholization and handling of radioactive materials.

EDUCATION

BS Chemistry, Southern Illinois University Edwardsville, 1991.

TRAINING & SKILLS

Life By Design –Dr. Rich Brinkman Career Track (4 hr) 2009

Communicating With Tack and Professionalism Fred Pryor (2-Day) 2008

Minimizing Integration Errors –Dr. T Jupille (4 hr) 2007

PAT Applications of -NIR Chemometric Calibration ACS (2-day) 2006

Center for Creative Leadership –Leadership Program (5-day) 2005

LC Resources Method Development and Validation (2-Day) 2004

Leadership Through People Skills (2-day) 2003

Targeted Selection-Behavioral Interviewing 2002

Theory of Constraints/Constraint Management (2-day) 2001

Hewlett Packard HPLC-Diode Array Course (5-day)-1998

Coaching For Success(2-day)-Mallinckrodt-1998

Dale Carnegie (13 week course in effective communication)-1998

Juran Quality Facilitation (5-day) Mallinckrodt-1997

High Performance Work Teams-(5-day) Mallinckrodt-1997

AAIM Statistical Process Control-1996

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