Location:
911 Century St, Hampstead, MD 21074
Work:
Amgen
- Providence, Rhode Island Area since Jan 2013
Senior Specialist Operations Regulatory Compliance
North Carolina Biotechnology Center
- NCSU since Jan 2009
Short Course Instructor
Amgen
- Providence, Rhode Island Area Mar 2011 - Jan 2013
Senior Manager, Manufacturing
Amgen, Inc
- Providence, Rhode Island Area Feb 2005 - Mar 2011
Senior Manager, Process Validation & Quality Lead
Amgen
Feb 2002 - Feb 2005
Validation Lead
Immunex (Amgen)
Feb 2001 - Dec 2002
Senior Validation Specialist
Immunex/Wyeth Biopharma
2001 - 2002
Senior Validation Specialist
Valsource, Inc
May 1999 - Feb 2001
Validation Specialist (consultant)
Glaxo Wellcome Biopharmaceuticals
Jul 1997 - May 1999
Validation Engineer
Monsanto/Searle
1993 - 1994
Research Biologist
Education:
University of Rhode Island 1994 - 1997
PHD inc., PhD program in Biological Sciences
Truman State University 1989 - 1993
BS, Biological Sciences
Skills:
Validation, Gmp, Biopharmaceuticals, Biotechnology, Fda, Quality System, Change Control, V&V, Capa, Cleaning Validation, Quality Assurance, Aseptic Processing, Cell Culture, Sterilization, Regulatory Affairs, Regulatory Submissions, Process Validation, U.s. Food and Drug Administration, Corrective and Preventive Action, Validation Master Plans, Aseptic Technique, Cross Functional Team Leadership, Protein Purification, Protein Production, Contract Manufacturing, Verification and Validation, Deviation Management, Team Building, Cip Systems, Sterility Assurance, International Project Management, Manufacturing Operations, Executive Coaching, Small Business Development, Strategy Development, Marketing Strategy, Technical Writing, Investigations, Cgmp, Regulatory Strategy, Fda Gmp, Cmc Regulatory Affairs, Pai, Cmo Management, Protein Chromatography, Bioreactor, Ultrafiltration, Homogenization, Tff, Mergers and Acquisitions
Interests:
Football
Collecting Antiques
Exercise
Home Improvement
Reading
Shooting
Gourmet Cooking
Sports
The Arts
Golf
Home Decoration
Health
Watching Sports
Photograph
Children
Diy
Cooking
Gardening
Outdoors
Electronics
Managed Annual Charity Haunted Hayride
Education
Baseball
Crafts
Fitness
Music
Science and Technology
Camping
Dogs
Movies
Collecting
Kids
Aed and First Aid Certification
Medicine
Diet
Automobiles
Walking
Woodwork
Travel
Wine
Motorcycling
Watching Baseball
Operational Excellence
Career
Investing
Traveling
Executive Coach
Watching Football