- Expert in solid oral, liquids and transdermal pharmaceutical dosage forms.
- 15 years of pharmaceutical Quality Assurance, research and development and commercial manufacturing experience.
- Process expertise in development and manufacture of solids, liquid and transdermal dosage forms.
- Supply chain experience in warehouse and distribution operations, including design and operation of Automated Storage and Retrieval Systems (AS/RS).
- Technical expertise in qualification of equipment, utilities and facilities, cleaning and process validation.
- In depth knowledge of cGMPs, ICH Guidelines, EU, and DEA regulations.
- International experience with European countries, including long-term assignment in Europe.
Independent Consultant, Technical Services and Validation, 2004 - Present
- Supervised qualification of new pilot manufacturing facility, utilities, and equipment, including management of staff consultants.
- Reviewed combination drug/medical device product for compliance to CMC section of NDA.
- Developed protocols and executed qualification related to solids, liquid process and vial filling equipment including V-Blenders, high shear mixer, tablet press, Ross Mixers and tablet coaters.
- Wrote and executed process validation protocol for gel product.
- Acted as validation manager and oversaw multiple validation projects, including process validation of suppository manufacturing process, including applicable equipment and utilities qualification and supporting cleaning validation.
- Reviewed, approved, and assisted client with installation, operation, and performance qualification of new ($1 million) automated commercial packaging line.
- Developed protocols and executed qualification with client of automated transdermal processing line.
- Developed and executed cleaning certification protocols for V-blenders, tablet presses and liquids processing equipment using swab and rinse sampling for analysis by HPLC/TOC and conductivity.
- Developed blend homogeneity protocols for solid dose product in V/Cone blenders.
- Functioned as "Man in Plant" supervising manufacture of solid oral dose clinical supplies using electronic batch record system at client sites.
- Conducted technical evaluation and recommendation of used tablet presses for client purchase.
- Developed temperature mapping protocols for, cGMP warehouses, portable sampling rooms and refrigerators.
- Commissioned and led qualification of Chilled Water and DX HVAC Systems, and ancillary equipment.
- Co-developed protocols and executed validation of PC based custom in-house bar-code label and automated dispensing systems.
- Validated automated storage retrieval system including preparation of user and system requirements documents.
DPT Laboratories, Director, Quality Systems, 2004
- A contract manufacturer of Rx, Generic, and OTC specializing in creams, liquids, lotions and gel products.
- Manage Quality Systems Operation consisting of Quality Control, Quality Assurance and Validation Departments totaling 55 persons.
- Reviewed and approved validation protocols for process, cleaning and equipment qualification.
- Re-vamped receipt and inspection process for incoming components, including sampling and inspection.
- Initiated reforms to CAPA and validation program to improve scientific justification and robustness of results.
- Provided regulatory guidance and design proposals for major site facility upgrade.
Lavipharm Laboratories, Inc., Vice President, Director - Quality Assurance, 1997 - 2003
- A private start-up pharmaceutical research and development company, specializing in drug delivery.
- Developed a quality plan defining phased roll-out of policies and procedures related to document development, change control auditing, cGMP training and CAPA systems.
- Reviewed and approved material specifications, test methods, release of raw materials, API, and drug product, and OOS/investigations. Established CAPA system. Performed internal audits of quality system, and external supplier, sub-contractors, laboratories.
- Partnered with research and development to oversee pre-clinical and clinical activities, including manufacturing and shipment, returns, and adverse event reporting of phase I-III clinical trial materials.
- Set-up clinical material supply group and supporting physical and administrative infrastructure for receipt, storage, shipment, and reconciliation of clinical investigational material, including controlled substances (DEA) compliance program for schedules II-V.
- Established calibration and validation program for all laboratory and process equipment, utilities and facilities.
- Worked with VP of regulatory to prepare NDA/ANDA submissions.
Novartis Pharmaceuticals, 1973-1997
Manager - Quality Control, Manager - Project Manager, 1992 - 1996
- As Project Manager, utilized "world class manufacturing", supply chain logistics, and information technology concepts and forged a strong team that spearheaded facility design planning process and plant layout, with all plant disciplines, for a $120 million renovation of multi-site production consolidation.
- Using business process re-engineering and other TQM principles.
- Led quality control improvement team that demonstrated reduction in end product testing throughput time through strategic realignment of human and fixed laboratory assets.
- Managed quality control equipment calibration and qualification program.
Manager - Warehouse, Dispensing and Site Services, 1987 - 1992
- Planned/implemented successful operational concept and startup of a new $14.5 million integrated automated hi-rise warehouse. Completed performance testing and validation of the computer control system in three months.
- Managed a 37-person team responsible for inventory, warehousing, environmental and site support for a 600-employee operation.
- Established user requirements for technical bar code labeling and automated dispensing systems.
Honors & Publications
Academic and Professional Affiliations
- Member International Society of Pharmaceutical Engineers and former ASQ
- Professional Certificate, Drug Development, Temple University.
- Temple University-Completed coursework towards MS in Quality Assurance/Regulatory Affairs, Coursework in Analytical Instrumentation Techniques-Middlesex County College.
- International (Switzerland) assignment studying logistics and manufacturing systems.
- General business management and finance training (Corporate), business process redesign techniques, TQM, world class manufacturing, continuous improvement.
- ASQ Certified Quality Auditor.
- Fluent in Spanish, writing and conversation.
- B.S. Life Sciences, Glassboro State College, Glassboro, NJ
- Mini MBA - Rutgers University
- Professional Certificate, Drug Development, Temple University