Manager Medical

Mark M. Silverberg

** **** ******* ******, ***** 5001 ac8qvr@r.postjobfree.com

Chicago, Illinois 60611 Linkedin.com/in/mark-silverberg-40637662

(847) 977 - 8917

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CORE STRENGTHS

C-Suite / Executive leader in FDA-regulated industry (e.g. pharmaceuticals, medical devices, diagnostics), with organizational responsibility for 450 employees. Proven competencies: o Strategic Planning

o Quality Systems Policy Development & Deployment (global application) o Compliance Programming / Risk Mitigation

o Manufacturing Infrastructure Modernization / Automation (multi-site) o Regulatory Liaison / Regulatory Compliance Expertise (e.g. FDA, DEA, ISO, ICH, et. al.) o Lean Manufacturing / Six Sigma acumen, leading in performance excellence / process optimization EXPERIENCE

Executive Vice-President, Akorn Pharmaceuticals, Lake Forest, Illinois 2005 – 2018 Pharmaceutical (Aseptic / Non-Sterile) Manufacturing Key Accomplishments: o Oversaw manufacturing changes (multiple sites) to increase throughput capacities by 300% o Implemented enhanced training / documentation practices to reduce deviations by 90% o Added process efficiencies to reduce customer backorder > 70% o Launched 3rd Party Alliance / Qualification Program, responsible for 40% of annual revenues o Protected key product market share, resulting in $100 million additional sales Director, Abbott Laboratories, Abbott Park, Illinois 1988 – 2005 Medical Device / Diagnostic / Pharmaceutical (Aseptic & Non-Sterile) Manufacturing Key Accomplishments:

Mark M. Silverberg

10 East Ontario Street, Suite 5001 ac8qvr@r.postjobfree.com Chicago, Illinois 60611 Linkedin.com/in/mark-silverberg-40637662

(847) 977 - 8917

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o FDA Consent Decree resolution / removal (key contributor) o Reduction of customer complaints (> 20%) using close loop feedback & analysis system o 100% FDA site inspection approvals, supported by authoring corporate manual for inspections. o Streamlined product label development / approval process with 50% timeline compression o Initiated statistically based division validation program (14 manufacturing sites), improving process controls and reducing incidents of rejected product batches. o Abbott President’s Awards (3): Performance Excellence, Execution of Critical Objectives EDUCATION AND TRAINING

o Bachelor of Science, Biology – Marquette University o Healthcare Administration courses - University of Chicago Medical School o Training and organizational certificates:

o ASQ – Certified Quality Manager

o Management Communications

o Strategic Planning / Problem Resolution

BOARD ASSOCIATIONS

o Board of Director - Children’s Research Foundation - Lurie’s Children Hospital o Board of Director - (20 years, 9 of which as President) - Congregation B’nai Shalom

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