Quality Control Raw Materials

REX E. REICHWEIN

*** ****** **., ************, ** 19148

Tel: 610-***-**** ***************@*******.***

PROFESSIONAL SUMMARY

Results-oriented analytical/quality control laboratory chemist possessing a strong background of cGMP/GLP compliance with over thirty years of experience in the pharmaceutical industry. Strong knowledge of USP/EP, ICH and FDA requirements for drug applications. Excellent communication skills, project leadership, ability to coach and develop direct reports.

WORK EXPERIENCE

AAA PHARMACEUTICAL INC., Lumberton, NJ 2015-2020

Quality Control Supervisor

Oversaw laboratory operations and personnel ensuring routine testing, data review and compliance for raw materials (API/excipients), in-process, finished product and stability samples.

Responsible for direct hiring, development, and evaluation of personnel.

Review/create SOPs, test methods and specifications and ensure compliance with USP/NF, ICH and FDA regulations.

Develop, validate, troubleshoot/optimize analytical methods for drug substances and drug products, including writing validation protocols and reports.

Ensure proper maintenance, calibration and troubleshooting of equipment.

Create IQ/OQ/PQ protocols and reports for equipment qualifications including updates for data acquisition systems (Waters Empower).

Participated in audits and qualification of raw material suppliers and outside testing laboratories.

Established procedures to ensure raw materials and finished products were compliant for Elemental Impurities (USP <232> & <233>/ICH Q3D (R3)) and Residual Solvents (USP <467>/ICH Q3C(R8)).

Ensure proper laboratory deviation investigations regarding OOS, OOT and aberrant results. Guide other chemists in the investigation and documentation process. Author/approve investigation reports and CAPAs.

Responsible for training and safety programs for laboratory personnel.

Participated as Subject Matter Expert for internal, external and government regulated compliance inspections.

DELAVAU, Philadelphia, PA 2013-2014

Manager of Quality Control and Analytical Methods Development

Managed a staff of 14 analysts responsible for the release testing and stability of raw materials, OTC (over the counter) and VMS (vitamins, minerals & supplements) products.

Provide leadership to team members, guiding them in prioritization of assignments, problem solving, and process clarification with strict adherence to compliance.

Laboratory point person for customer complaints, inquiries, audits and regulatory inspections.

Review of FDA/USP/EP Compendial updates to ensure that existing methods, specifications (API, excipients, FP, components) and SOPs are compliant and ensure appropriate updates are implemented.

Implemented a reduced testing program for raw materials to increase manufacturing efficiency.

Established the use of BioLumix and water activity for microbiological testing allowing for faster product release.

Oversaw the development/validation of UPLC methods for the conversion from HPLC methods for shorter analysis times and reduction in solvent use.

SPI PHARMA, Lewes, Delaware 2012-2013

Quality Laboratory Manager

Managed a staff of 15 analysts comprising Analytical, Quality Control and Microbiology for a manufacturer of APIs and Finished Dosage Forms.

Schedule daily testing activities for product release and analytical method development, validation and technology transfer.

Ensure that departmental quality, compliance, regulatory and safety systems are maintained in accordance with current regulations.

Provide guidance, coaching and training on departmental SOPs, USP/EP regulations and ICH guidelines.

Worked closely with Production to reduce “in process” testing through method improvement and harmonization resulting in higher throughput and cost savings.

Review and approve SOPs, test methods, calibration procedures, validation protocols and reports, investigations and CAPAs.

REX E. REICHWEIN

BAXTER HEALTHCARE CORPORATION, Cherry Hill, New Jersey 2008-2011

Associate Research Scientist, Technical Services (Consultant through Kelly Services & AllSource)

Analytical SME for the Technical Services Department overseeing chemistry related issues for production and QA/QC testing.

Liaison between 3rd party contractors and QA/QC responsible for technical transfer of methods and transfer of data for NDA/ANDA filings and for commercial products.

Analytical lead for development/validation of methods for “grandfathered” products. Working closely with contract laboratories to ensure compliance for NDA filings. Reformulation of existing “grandfathered” products through QbD (Quality by Design/ ICH Q8, Q9 & Q10) from lab-scale batches to demonstration and registration batches.

Investigated production problems resulting in OOS/atypical results for numerous parenteral products. Identified CAPA and responsible for ensuring that the findings/improvements were made through Change Control.

BAXTER HEALTHCARE CORPORATION, Cherry Hill, New Jersey 2002-2007

Manager I, Analytical Research and Development

Led seven-member team to develop and validate analytical test methods for numerous APIs, excipients, and finished product injectables and other pharmaceutical products.

Coached and developed diverse team comprised of Ph.D., Master’s level and Bachelor’s degree members. Hired and trained new employees on departmental SOPs and guidances; conducted employee appraisals with development plans for growth.

Scheduled analytical activities to support project completion. Activities included method development/validation, stability and product development testing, and transfer of methods to QC.

Worked closely with the Regulatory, Pharmacy, Process Development, and Quality Control departments in the preparation of regulatory documents for ANDA filings.

Set specifications for APIs, excipients and finished products based on analytical data, and strong knowledge of USP/EP, ICH and FDA requirements.

Oversaw the calibration program including the creation of procedures, execution of Instrument Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) of laboratory equipment and 21CFR Part 11 qualification of computer software.

ESI-LEDERLE (WYETH PHARMACEUTICALS), Cherry Hill, New Jersey 1995-2001

Unit Supervisor, Analytical Research and Development 2000-2001

Supervised four-member team in a satellite laboratory for the development of the first generic sterile powder blend antibiotic.

Established a satellite laboratory with functions including the purchase of all laboratory equipment, IQ/OQ/PQ of equipment and writing of SOPs and calibration procedures.

Successfully led transfer of methods to five different Quality Control laboratories throughout the world.

Sr. Scientist, Chemist III, Chemist II, Chemist I, Assoc. Chemist, Staff Chemist, Analytical R & D 1995-2000

Developed and validated various analytical methods for injectable drugs including creation of protocols and final reports.

Executed troubleshooting for existing QC methods to increase efficiency and to meet current ICH/USP guidelines.

Team member of Quantic Group audit for review of SOPs for conformance to corporate SOPs/guidelines as a result of “Consent Decree” of a sister site.

SMITHKLINE BEECHAM PHARMACEUTICALS, KING OF PRUSSIA, PA 1990-1994

Associate Scientist, Biomolecular Discovery Department

Isolated and identified antineoplastic inhibitors and other active compounds from natural sources for various bioassays which led to several publications in scientific journals. Applied chromatographic techniques to isolate novel compounds and assisted in characterizing these compounds using spectroscopic techniques including LC/MS, NMR, and X-Ray crystallography.

REX E. REICHWEIN

EDUCATION AND TRAINING

TEMPLE UNIVERSITY, Philadelphia, PA B.S., Chemistry 1991

Baxter Management Courses: Impact (team building, motivation, communication and personality preferences)

TECHNICAL EXPERTISE

Laboratory Instrumentation:

Chromatography: HPLC, UPLC, GC, LC/MS, GPC/SEC, IC, TLC

Other instruments: Wyatt, TOC, UV/VIS, AA, FT-IR & NIR Spectroscopy, ICP-MS, ICP-OES, Auto-titration, Viscosity, AquaLab, BioLumix

Computer Programs:

Data Acquisition Systems: Waters Empower, PE TotalChrom, iTEVA, Tiamo

SQL*LIMS, isoTrain, Trackwise, Life Cycle Management, Qumas

Microsoft: Word, Excel, Power Point

Contact this candidate