Philip R. Strom-Jensen, PhD
Sr. Quality Engineer/Project Leader
Phil is a senior technical leader (Ph.D. Biophysics) with more than 20 years of cost effective project management, international technology transfer, and FDA compliant process development and validation expertise. He has extensive experience in validation and quality systems for the biotech, pharmaceutical and medical device industry. Phil’s professional experience includes tenure at Dade Behring, Inc. as Director of Product /Process Development and Technology Transfer, as well as, Manager of Process Development and Product Support at Bayer Corp. Phil’s leadership has enabled vital FDA compliance of zero deficiency ratings through systematic process validation and critical documentation control. Phil is accomplished in the use of cross-functional project management and data analysis disciplines. Phil has managed significant budgets (>$2 million) and support staff. At Bayer, Phil facilitated introduction of twenty-five products in three years. He has superior expertise in project management, team leadership, strategic project planning, resource allocation and tracking and organizational development against process and capacity growth strategies.
Phil qualifies as a senior technical leader in healthcare new product development and manufacturing. Phil is proficient in German and sensitive to cross-cultural communication. Phil is accomplished in use of project management and data analysis software.
EXPERIENCE:
THE STROM-JENSEN GROUP, INC., Conshohocken, Pennsylvania
President, consulting in validation, technology transfer and process development for biotechnology.
- Gap Analysis and preparation of pharmaceutical manufacturing
- Audit and Quality Systems improvement for FDA-Readiness
- Preparation of compliance master project plans
- Review and improvement of qualification and validation protocols and reports.
- Development of Validation Master Plans
- Process validation protocols for complex manufacturing
- Test Method Validation
- Product Transfer and Cleaning Validation programs
- Installation and Operational Qualifications
- Redesign of production documentation for efficiency and accuracy
- Development of semi-automated hazardous liquid filling process
- Clients include:
Pharmaceutical Manufacturing Sites in Switzerland, Portugal and Belgium
Medical Device Manufacturing Sites in Italy, Puerto Rico, New Jersey, Minnesota
Diagnostic Manufacturing Sites in New Jersey, California, Oregon, Florida
Consumer Health Product Manufacturing Site in South Africa
DADE BEHRING, INC., Miami, Florida
Director, Process Development for manufacturing processes and technology transfer.
- Created department of six engineers and scientists devoted to co-development of manufacturing processes and new products.
- Managed installation of equipment for new product formulation and filling requiring novel environmental tolerances ($1.1 million budget).
- Managed approval of company’s redesigned Process Validation System.
- Developed process capacity growth plans for emerging product lines.
BAYER CORPORATION, (formerly Miles, Inc.) Middletown, Virginia
Manager, Process Development/Product Support
- Demonstrated record of adapting R&D designs for manufacturing (25 products in 3 years).
- Achieved FDA compliance with a zero deficiency rating through systematic process validation and critical documentation control.
BAYER CORPORATION, Leverkusen, Germany
Product Development Liaison between U.S. subsidiary and German headquarters
- Ensured that German production process was restructured appropriately
- Technical support at sites other than U.S. based projects including in German, Belgium and Ireland.
- Co-authored German and U.S. patents.
BAYER CORPORATION, Elkhart, Indiana
Technical Production Supervisor
Research Scientist
- Designed and developed improved glucose monitoring strips (Glucostix/Visidex).
- Received Corporate Trade Secret Award for aqueous coating preparation process and 2 Science and Technology Awards for innovative research.
EDUCATION:
Ph.D., Biophysics, University of Illinois at Urbana-Champaign, Urbana, Illinois
B.A., Physics, Pomona College, Claremont, California
