Mary Dankulich Email & Phone Number
Director @ Lachman Consultant Services
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Mary Dankulich Location
- Philadelphia, PA, US
Mary Dankulich Work
- 2022 -now Director @
- 2012 -2022 President @ The Dankulich Group, LLC
- 2010 -2012 Senior Director, Consent Decree Operations @
- 2010 -2011 Senior Director, Sustainable Compliance @
- 2008 -2010 Vice President, Strategy, Operations, and Compliance @
- 2006 -2008 Sr. Director, Global Labeling @
- 2001 -2006 Senior Director, Compliance Systems and Documentation @
- 1992 -2001 Director, Worldwide Regulatory Affairs @
- 1990 -1992 Documentation and Technical Specialist @ Wyeth-Ayerst International, Inc.
- 1988 -1990 Quality Associate @ BCM Environmental Laboratories
- 1987 -1988 Chemist @ IMC Pitman- Moore (subsidiary of Johnson & Johnson)
- 1986 -1987 Senior Technician @ Atlas Powder Company
Mary Dankulich Education
- Saint Joseph's University
MBA (General Management)
1990-1995 - Cedar Crest College
B.S. (Chemistry & Psychology)
1983-1986 - Pittston Area High School
Mary Dankulich Skills
- Pharmaceutical Industry
- GMP
- Vaccines
- GLP
- GCP
- Pharmaceutics
- eCTD
- NDA
- CMC
- Regulatory Submissions
- IND
- GxP
- Biologics
- 21 CFR Part 11
- Regulatory Affairs
- Computer System Validation
- Pharmaceutical Manufacturing
- Aseptic Processing
- Cleaning Validation
- Pharmacovigilance
- Compliance
- Sop
- Regulatory Requirements
- Quality Control
- Chemistry
- Change Control
- CAPA
- Biotechnology
- FDA
- Quality System
- Validation
- Drug Development
- V&V
- Technology Transfer
- Clinical Development
- Clinical Trials
- Cross-functional Team Leadership
- Standard Operating Procedure (SOP)
- U.S. Food and Drug Administration (FDA)
- Troubleshooting
- HPLC
- u.s. Food and Drug Administration Fda
- Analytical Chemistry
- Management
- Sales
- Strategy
- Cross Functional Team Leadership
- Standard Operating Procedure Sop
- Project Management
- Standard Operating Procedure
- u.s. Food and Drug Administration
Mary Dankulich Summary
- Mary Dankulich, based in Philadelphia, PA, US, is currently a Director at Lachman Consultant Services. Mary Dankulich brings experience from previous roles at The Dankulich Group, LLC, McNeil Consumer Healthcare and Pfizer Consumer Healthcare. Mary Dankulich holds a 1990 - 1995 MBA in General Management @ Saint Joseph's University. With a robust skill set that includes Pharmaceutical Industry, GMP, Vaccines, GLP, GCP and more. Mary Dankulich has 1 emails and 1 mobile phone numbers on RocketReach.
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