Raymond Cerny

About Raymond Cerny

Highly organized and results oriented professional. Ability to successfully…

Experience

1. Sr Scientist, Chemistry, Mfg & Cntrl

   Cardinal Health

   Mar 2015 — Present · Overland Park, KS, US

   Apply pharmaceutical industry experience and regulatory affairs knowledge to meet project objectives, while managing several ongoing and shifting priorities across multiple project timelines and scopes of work.Author CMC related variations for drug products registered across multiple markets, by identifying the drug products current registration status in the affected markets, gather the currently registered CMC information for comparison against proposed submission section content, determine specific market documentation requirements, and prepare appropriate documentation for review and approval by product management.Conduct thorough review and evaluation of CMC documents and other data (QA, QC and manufacturing) to ensure compliance with USP, FDA and ICH quality guidelines.Prepare, assemble and review FDA Annual Reports, DMF updates and perform life cycle management.Cardinal Health Regulatory Sciences provides global product development consulting services to help biopharmaceutical and medical device companies accelerate regulatory approval while delivering high quality documentation and guidance. Our collaborative, cross-functional approach has resulted in more than 500 product approvals worldwide and we are currently working to drive development efficiencies in more than 140 countries. Our team of more than 200 regulatory and scientific experts, averaging 18 years of industry experience, helps our clients accelerate time to market and reduce risk throughout the entire development continuum.

Education

• Roosevelt University

  MBA, International Business

  1990 — 1994

• College of Lake County

  Pre-Engineering

  1981 — 1983

• Iowa State University

  BS, Chemical Engineering

  1983 — 1986

Skills

• Documentum
• Strategy
• Outlook
• Sharepoint
• Adobe Acrobat
• Iso 13485
• Process Improvement
• Isi Toolbox
• Pharmaceutical Industry
• Sop
• Deviation Management
• Fda
• Medical Devices
• Capa
• Ectdxpress
• Regulatory Affairs
• Filtration
• Gmp
• Quality Assurance
• Electronic Common Technical Document (Ectd)
• Regulatory Submissions
• Quality System
• V&V
• Technical Writing
• Cmc
• Microsoft Office
• Ms Office
• Validation
• Lotus Notes
• Change Control
• U.s. Food and Drug Administration (Fda)
• Complaint Investigations
• Manufacturing
• Ectd
• Compliance
• Qualification
• Aseptic Processing
• Technology Transfer
• Biopharmaceuticals
• Microbiology