
Carl Blankemeyer
Thirty-three years with Merck in Pharmaceutical Production, Printing Operations, Incoming Production Supplies Inspection, Warehousing and, most recently, Research... | Greater Philadelphia, Greater Philadelphia, United States
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Carl Blankemeyer’s Emails ca****@as****.com
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Carl Blankemeyer’s Location Greater Philadelphia, Greater Philadelphia, United States
Carl Blankemeyer’s Expertise Thirty-three years with Merck in Pharmaceutical Production, Printing Operations, Incoming Production Supplies Inspection, Warehousing and, most recently, Research including GMP Compliance, regulatory project management and worldwide Regulatory Affairs. Final eighteen years in the Regulatory Affairs area at Merck; experience with FDA communications, review/approval process support and interaction; FDA Liaison, Liaison support and document preparation, assembly and submission. Extensive IND and NDA original filing and amendment background; more recently one of the SME's for the EU Clinical Trials Directive at MRL Headquarters; experience interfacing with EU and ex-EU subsidiary offices, and years of experience in preparation, assembly, and release of international dossiers, including CSA's and IMA's. In addition, almost two years as a Regulatory Project Manager at Covance; Two years as a contract regulatory Manager with mid-size (Shire) and large (AstraZeneca) pharma. Two years at Janssen R&D, LLC in Regulatory Project Management in the Neuroscience, Oncology and Immunology Therapeutic areas. Experience managing up to nine exempt employees. Excellent communications and interpersonal skills; outstanding ratings throughout my career. References available. Specialties: People Management, EU Clinical Trials Directive, Coaching/Mentoring, Common Technical Document (CTD)
Carl Blankemeyer’s Current Industry Athersys
Carl
Blankemeyer’s Prior Industry
Us Army
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Merck
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Janssen Pr And D
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Astrazeneca Via Greenkey Resources
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Covance
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Athersys
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Work Experience

Athersys
Associate Director Regulatory Affairs
Sat Oct 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Oct 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Merck Global CMC Regulatory Affairs
Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Mar 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Covance
Regulatory Project Manager
Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Nov 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Astrazeneca Via Greenkey Resources
RegulatoryAffairs Manager
Sat Aug 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jun 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)
Janssen Pr And D
Regulatory Program Manager
Sun Apr 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jul 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Manager
Wed Oct 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Mar 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Assoc Director, Worldwide Regulatory Coordination
Tue Nov 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Oct 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Sr. Regulatory Coordinator
Sat Jan 01 1994 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Nov 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
GMP Compliance Auditor
Sun Sep 01 1991 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Dec 01 1993 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Lead Production Supervisor, Finished Goods Warehouse and Dist.
Wed Mar 01 1989 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 1991 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Quality Control Auditor,Contracts and Incoming Supplies Inspection
Thu Jan 01 1987 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Feb 01 1989 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Supervisor, Printing Operations
Sun Jan 01 1984 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Dec 01 1986 00:00:00 GMT+0000 (Coordinated Universal Time)
Merck
Quality Control Inspector
Mon Feb 01 1982 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Dec 01 1983 00:00:00 GMT+0000 (Coordinated Universal Time)
Us Army
Line and Staff Officer
Thu Jun 01 1978 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Nov 01 1981 00:00:00 GMT+0000 (Coordinated Universal Time)