Jim Gerhardt
Senior Manager, Clinical Supply at Mallinckrodt Pharmaceuticals
- Role
- Senior Manager, Clinical Supply at Mallinckrodt Pharmaceuticals
- Location
- Allentown, PA, US
- LinkedIn followers
- 500 followers
About Jim Gerhardt
Certified PMP; Subject matter expert in the following areas: clinical packaging and labeling production, clinical label and kit design, blinding by overencapsulation, project management for clinical studies that require method development/validation and stability testing of new comparator products to support blinded clinical trials. Management of global project teams, creation and maintenance of project timelines and budgets. 8 years experience in clinical packaging project management, 14 years experience in manufacturing project management and 2 years experience in analytical laboratory environment.
Experience
Senior Manager, Clinical Supply
Jun 2019 — Present · Bedminster, NJ, US
Education
Frostburg State University
BS, Biology
1997 — 2002
Skills
- Clinical Research
- Capa
- Pharmaceuticals
- Visio
- Excel
- Validation
- Cgmp
- Packaging
- Glp
- Gxp
- Corrective and Preventive Action (Capa)
- Inventory Management
- 21 Cfr Part 11
- Gmp
- Microsoft Office
- Quality Assurance
- Customer Relations
- Lims
- Ctms
- Standard Operating Procedure (Sop)
- U.s. Title 21 Cfr Part 11 Regulation
- CRO
- Customer Service
- Clinical Trials
- Powerpoint
- Microsoft Excel
- Pharmaceutical Industry
- Business Process Improvement
- Sop
- Fda
- Process Improvement
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