Joseph S. Ranweiler, Ph.D.
1361 Derby Rd.
Warminster, PA 18974
Phone:
(215) 828-1386; (215) 674-1429
E-mail: jranweiler1@gmail.com
Specialties:
- Analytical
- Pharmaceutical
- Research and Development
- Project Management
- Product Stability
- Data Evaluation
- Technology Transfer Across Sites
Services:
- Analytical Chemistry & Pharmaceutical Consultation
- Analytical Report Writing for Product Development; includes Methods, Method Validation, Stability, & Method Transfer.
- Review and/or Audit of CM&C sections for Regulatory Submissions.
- Project Management for CM&C R&D. Schedule of Activities and Requirements for Product Development.
- Technology Transfer for Analytical Methods to Manufacturing & Testing Sites. Technical Documents Requirements and Method and Site Transfer Procedures.
- FDA Method Validation Package Requirements.
- Write and Review SOP's Documenting Department Procedures.
Experience:
- Johnson & Johnson - Pharmaceuticals R&D Division - 31 years of product development.
- Delivered on the preparation and approval of 20+ pharmaceutical product includes recent simultaneous submission in the US, Europe, and ROW. As Analytical Technical Team Leader, delivered technical reports for the common technical document for the filings. Standard of Leadership awards received for an analgesic project, an antipsychotic project, and a patent protection project. Supported important company products by approvals of product line extensions and product improvements resulting in the growth in product value to the company.
- Successfully represented the company during communications with the regulatory agencies during pre-NDA meetings, resolution of agency questions, and pre-approval inspections (PAIs).
- Managed the activities of department staff and authored/reviewed reports required for regulatory filings including specifications, analytical methods, method validation, technology transfer, and product stability.
- Managed technical teams in a matrix Project Team structure. This required cross-company coordination of project activities to meet project goals and resource planning and coordination of staff activities at multiple sites.
- Mentored department staff on technical and regulatory requirements for successful product development in the global environment.
