R. Michael Gipprich

**** ******* ***** ***** ****** Mills, MD 21117

410-***-**** actl26@r.postjobfree.com

Analytical Scientist

EXTENSIVE LEADERSHIP EXPERIENCE WITHIN TOP-TIER PHARMACEUTICAL COMPANIES

Highly technical, research-driven Senior Chemist proven in planning and directing complex pharma projects in line with cost, time and quality requirements. Focused on supporting and enhancing applied research, analysis and quality control within fast-paced laboratory settings. Engaging coach and mentor of junior chemists, depended on to drive collaborative, positive environments for cross-functional, multidisciplinary teams.

Areas Of Expertise

Chemistry Processes

Analytical Testing

Project Management

Protocol & SOP Development

Research & Development

Laboratory Standards

Quality Assurance

Program Management

Equipment Evaluation

Technical Troubleshooting

Budget Development

Team Leadership

Training & Development

Cross-Team Collaboration

Communications

Technical Expertise

Instrumentation & Lab: HPLC; GC; FTIR; Dissolution (Apparatus I and II); XRF; Osmometry; UV/Vis; HP8453 Spectrophotometer; Karl Fischer Titration; “wet chemistry” techniques

Desktop Applications: MS Office Suite (Excel, Outlook, PowerPoint, Word), Empower 2, Documentum

Professional Experience

UPM PHARMACEUTICALS Dundalk, MD

Senior Analytical Chemist 2012 – 2014

Manager, Quality Control 2005 – 2012

As Analytical liaison with Quality Assurance, performed analytical test methods, method transfers, qualifications and validations on complex projects.

Utilized Chromatography (HPLC (Alliance 2695), UPLC (Acquity H Class), GC (Agilent 6890N)), UV-Vis (HP8453), FTIR (Thermo Nicolet 6700) and Karl Fischer (Metrohm 799 Titrino) analyses in support of method development, method validation, in-process testing, raw material testing, finished product and stability testing.

Utilized Dissolution systems (Distek 6100 & 2100), with auto samplers (Distek 4300, Distek 2230A and VanKel VK8000) in support of method development, method validation, in-process testing, finished product and stability testing.

Served as System Administrator for Empower 2 chromatography software.

Performed numerous compendial (USP, BP, EP JP) tests for raw material release.

Collaborated with clients to update project status and analytical testing results.

Coordinated, tested and reviewed data across all types of samples in collaboration with external labs.

Developed method validation protocols, stability testing protocols, release specifications and SOPs.

Performed method validations and method transfers in compliance with ICH guidelines.

Created and implemented specifications for raw materials, finished products and stability samples to drive compliance with compendial and cGMP requirements.

Recommended equipment and personnel improvements to senior management.

Assisted with writing of departmental budget.

R. Michael Gipprich, Page 2

2041 Hunting Ridge Drive Owings Mills, MD 21117

410-***-**** actl26@r.postjobfree.com

Professional Experience (Continued)

Key Engagements

Authority over numerous high-level programs, including:

oLaboratory instrument maintenance and calibration program.

oRaw material testing program.

oLaboratory hazardous waste disposal program.

oLaboratory CDS Program.

Enhanced team technical capabilities by training in operation and use of laboratory instruments.

Instrumental in continuous improvement via peer review of analytical data prior to submission to QA.

Integral in issue mitigation through laboratory investigations and reporting.

UPM PHARMACEUTICALS (CONTINUED) Dundalk, MD

Manager, Quality Control 2000 – 2005

Developed and performed analytical test methods in line with project processes.

Executed method validations and method transfers in compliance with ICH guidelines.

Wrote and revised SOPs to maintain compliance with CGMPs.

Created and updated specifications for raw materials, finished products and stability samples.

Oversaw various laboratory programs, ensuring compliance and quality adherence.

Evaluated and recommended change to fulfill equipment and personnel needs.

UNIGEN PHARMACEUTICALS Westminster, MD

Manager, Analytical Chemistry 1998 – 2000

Directed analytical chemistry processes spanning development of test methods, execution of method validations and method transfers, and writing of compliant SOPs.

Planned and led operations within various laboratory programs.

Served as Analytical liaison with Quality Assurance to ensure CGMP compliance.

Continuously evaluated and improved processes regarding equipment and personnel needs.

ALPHARMA, U.S. PHARMACEUTICALS DIVISION Baltimore, MD

Chemist III 1986 – 1998

Performed USP quality control testing methods on generic liquids and suspensions (HPLC, GC, FTIR, UV-Vis, Dissolution).

Validated and verified bulk and finished product release.

Performed analytical test methods for release and stability testing of generic products.

Facilitated method validations and method transfers in compliance with ICH guidelines.

Maintained and repaired 30 HPLCs and 4 dissolution baths.

Trained, coached and mentored chemists in instrument repair, maintenance and troubleshooting.

Audited and released data for finished products, in-process and raw materials.

Education

Associate of Arts, General Studies

Catonsville Community College, Baltimore, MD

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