Al Petro Email & Phone Number

Tamarac, FL, US

New Vision Pharmaceuticals is a full-service, FDA-registered contract development and manufacturing company that provides innovative solutions through blow-fill-seal (BFS), fill-seal (FS) and traditional packaging for liquid and semi-solid products in a breadth of industries, including pharmaceutical, diagnostic reagents, dietary supplements and a.

Tamarac, FL, US

• Leading producer of biologics and medical device/biologic combination products using regenerative technologies targeting a variety of ophthalmic, orthopedic, pain management and dermatological conditions.Manage end to.
• Define strategic and tactical plans to deliver significant increases in manufacturing output and broader product portfolio to support large revenue growth.
• Responsible for tissue acquisition using both internal resources and third party providers.
• Manage multisite aseptic manufacturing and distribution facilities supporting domestic and international markets.
• Direct technology transfer and scale up for new product commercialization.
• Responsible for CMO as well as internal production management.

• Publically traded developer and manufacturer of transdermal patch, topical and aseptic medications for neurological diseases. Acquired by Acorda Therapeutics, Inc.Responsible for pharmaceutical development, CMC, vendor.
• Develop drug/device combination products, and manage complex network of CMOs located in Asia, Europe and North America. Responsibility for FMEA and technical/commercial risk mitigation.
• Manage qualification and ongoing operations of intermediate, API and drug product CMOs as well as testing labs.
• Responsible for complete supply chain management from precursor materials to finished product.
• Direct Quality Management and CMC activities in preparation of NDA and other regulatory filings.
• Plan and execute remediation plans to address regulatory and compliance issues.

US

• Publically traded specialty manufacturer of drug/device combinations for neurological diseases.Acquired by Allergan, Inc. Responsible for process development, manufacturing, logistics and supply chain management.
• Directed CMC activities including API, drug product and finished combination device.
• Commercialized product and process design to allow high speed, automated manufacture.
• Developed and manage complex network of CMOs located in Europe and the US.
• Directed development of key portions of NDA and other regulatory submissions.
• Address regulatory compliance activities at vendors and CAPA support.

Jena, DE

• World leader in diagnostic and therapeutic products for ophthalmic, surgical and radiation delivery markets.Responsible for order to invoice activities involving $280MM in annual revenue.
• Managed captive and CMO organizations in Asia, Europe and the US producing high value diagnostic and therapy systems using advanced electro-optical, microarray and nano scale technologies.
• Responsible for transfer from development to commercial production of new products..
• Initiated satellite production of legacy products in Asia to support emerging markets.
• Demonstrated track record of identifying improvement areas, implementing formal cost savings/tracking systems and achieving long-term change.
• Corporate Compliance Officer.

Forchheim, DE

• Market leader in diagnostic ultrasound, patient data management and imaging catheters. Responsible for product development, manufacturing and technical support of ultrasound imaging products.
• Managed development and commercial introduction of next generation imaging systems, catheters and data analysis systems, thereby increasing revenue shipments to $680MM.
• Developed and executed plan to reduce HQ operations facilities while expanding international manufacturing footprint.
• Optimized logistics processes that reduced secondary costs by $24MM annually.
• Integrated value engineering activities into all design, manufacturing and support activities.

42579 Heiligenhaus, DE

• Global Tier One supplier of precision products to the automotive industry.Responsible for construction and start up of a new manufacturing and support facility
• Coordinated transfer from Germany to the US of a high volume, cost sensitive production facility generating annual revenue of $148MM.
• Launched three new products in the North American and European markets within first 6 months of operation.
• Use Step Change processes to define performance drivers, identify stretch targets, create multidisciplinary teams, drive rigorous and disciplined implementation, and bring alignment of an organization with corporate.

Stuttgart, Baden-Württemberg, DE

• World leader in industrial automation technology, pharmaceutical packaging and health monitoring. Director of Technical Support Designed and implemented process optimization, quality improvements and value engineering.
• Managed technology demonstration activities to highlight integration of optics, precision mechanics, control systems and software to meet unique customer needs.
• Integrated value engineering analysis into all design, manufacturing and support activities.
• Introduced aseptic process capability to new manufacturing systems.
• Reduced cost of quality nonconformance by 38% over 18 months.

Snoqualmie, WA, US

• Major supplier of patient monitoring and data analysis products.Directed the delivery of customer service, factory repair and refurbishment activities
• Reduced time-to-fix metrics by 31% and increased overall customer satisfaction.
• Responsible for consolidation of 3 manufacturing and service facilities into one location with resulting operating cost improvement of 42%.Developed high performance test systems to assess Rf communications between.

Forchheim, DE

• International supplier of diagnostic and therapeutic medical products.Direct US manufacture of MRI systems; streamline preparation of regulatory filings and reduce cycle time for FDA review.
• Responsible for start up and operation of MRI manufacturing facility producing more than $200MM in annual revenue.
• Reduced time for preparation and prosecution of PMA and 510(k) regulatory filings by 26% for diagnostic imaging, implantable pacing systems and therapy devices.
• Managed interface with regulatory agencies, including remediation activities.
• Key member of joint venture for development and manufacture of ultra-fast CT scanners.

Chicago, US

• International supplier of diagnostic and therapeutic products.Responsible for lab support and regulatory compliance during start-up and validation of a new manufacturing facility.
• Conceived, implemented and directed quality engineering during greenfield start-up of a facility producing superconducting MRI magnets.
• Responsible for all regulatory submissions from plant site.

Mj In Healthcare Law

Mba, Business

Bs Engineering, Materials And Metallurgy