Confidential, ON, CAN. June 2007 to September 2008
Manager of Analytical Services & Quality Assurance
- Assure that all quality control procedures are documented and have clearly defined quality specifications to allow appropriate auditing.
- Responsible for quality control functions required by the company including but not limited to in-process, component, and finished goodsinspections.
- Responsible for analytical method development and validation as well as policies, procedures, and compliance
- New product and manufacturing innovations unprecedented revenue totaling 3.2 million in new business
Confidential, Allegan, MI November 2006 to May 2007
QA External Manufacturing Auditor
- Responsible for the execution of global sourcing API and non-active ingredients.
- Develop sourcing strategy, vendor qualification, lead negotiations and write Quality Technical Agreements for various relationships governing Perrigo products, raw materials, analytical Services and API's. Ensures SOPs and polices are revised based on executed Quality Technical Agreements.
- Develop and implement assembly cost reduction strategy to ensure best-in-class package cost.
- Develop and execute substrate and assembly sourcing strategy, including capacity plans and manufacturability assessment/recommendations.
- Maintain material qualification program by working with Operations and Development groups to ensure appropriate qualification requirements are met.
- Conducts GMP, GLP, or GCP audits (internal and external), as applicable
- Maintain supplier evaluation / qualification program to ensure Perrigo uses suppliers which meet internal standards.
- Periodic monitoring and verification of operations to ensure compliance to written procedures and/or regulatory requirements
- Review and approval of quality-related documents, including but not limited to: protocols; qualification, validation and stability reports; test results, including raw data; calibration certificates; temperature charts
- Monitoring and verification of qualification and validation processes to ensure compliance to written protocols, and regulatory requirements, as applicable
- Developed global sourcing strategies to support current and future business growth/opportunities
- Lead activities in all phases of selection and negotiations to support operational aspects of product supply on a worldwide, regional or local basis.
- Investigation into alternative dosage form technologies as alternatives to softgels and solid dosage forms
Confidential, Somerset NJ September 2004 to November 2006
Pilot Plant Manager
- Ensure operations adhere to safety and quality standards as well as maintain production, maintenance, schedule and daily supervision of pilot plant operators
- Responsible for performance management of operators, provide appropriate training
- Coordinate with project management, logistics and analytical services to ensure proper planning QA
Quality Assurance Auditor(Sept 2004-July 2005)
- Conduct audits of Pharmaceutical Development to assure compliance
- Auditing analytical data, technical reports, method development, validation and R & D development reports.
- Audit of laboratory notebooks, analytical test methods, and technical test protocols for GLP compliance with Pharmaceutical development SOP's.
- Conduct GMP, GLP, or GCP audits (internal and external), as applicable
- Maintain material qualification program by working with Operations and Development groups to ensure appropriate qualification requirements are met and inspection of manufactured products, raw materials and chemicals
- Developed project plans including resource assessment, project strategies, timetables and budget maintenance.
- Escalated issues, deviations, investigations or trends discovered during the lot review to quality management
- Served on multi-disciplinary project teams to effectively meet project timelines and compliance to cGMP's.
QA Consulting, Confidential, NJ & San German, PR April 2003 to May 2004
Confidential, (October 2003 to May 2004)
Confidential, (April 2003 to July 2003)
- Audit all activities at facility identifying any cGMP or Quality deficiencies in manufacturing, analytical laboratory, facility, QA, contract or validation systems.
- Conduct laboratory audits, review analytical data (e.g. HPLC, FT-IR, UV, TOC, etc.)
Confidential, New York, NY May 2002 to February 2003
Manager, Manufacturing -Product Release
- Oversee the process of updating and defining SOPs for in-house manufactured products and conduct quality assurance audits in compliance with GLP/GMP requirements for in-house product development.
- Approve the finished products as "Released"; or "Rejected "; assuring that all pertinent data are entered into the official lot file.
- Audit production documents for compliance with federal regulatory requirements (CFR), specifications and Good Manufacturing Practices (GMP) and Good Laboratory Practices(GLP).
- Collaborate with laboratory investigators, Principle Investigators, IND (Investigational New Drug Committee), the IND Committee Chairman, and the Research Pharmacy on all aspects of new in-house product development.
Confidential, Ramsey, NJ March 2001 to March 2002
- Characterization of Alt-711 by H and C NMR utilizing long range and short range coupling experiments to verify structure
- Review and evaluation of analytical methods transfer and validation, evaluation of manufacturers' proposals and contracts.
- Audited three sites in Europe for strict laboratory and manufacturing compliance.
- Produced a new crystallization procedure that increased yields from 50% to 89%.
- Improved Alteon\'s synthetic process for making Alt-711 on a commercial cGMP scale which involved providing alternate synthetic routes for starting materials in a safe, efficient and cost effective manner.
- Implemented SAR database and synthesized new analogues for medicinal chemistry and patent support.
Confidential, West Point, NY April 2000 to March 2001
Quality Control Chemist
- Routine assay on precious metals by ICP, AA and fire assay.
Confidential, River, NY March 1998 to March 2000
- Responsible for identifying, testing, and recommending synthetic improvements to existing and newly developed processes.
- Development of laboratory processes from the bench on gram scale to the pilot plant on multi-kilogram scale utilizing 1000-liter reactors.
- Experience collecting and interpreting routine analytical data (e.g., IR, GC, HPLC, NMR (2D long and short range coupling experiments), GC, and LCMS)
- Isolated stable and unstable impurities by preparative LC. Identified compounds by NMR, LC-MS and HPLC. Prepared compounds and compared spectra with isolated impurities.
- Studied first step of MMP inhibitor reaction to generate hydroxyl amine. Process improvement to eliminate impurities and minimize steps from 13 to 9 overall.
- Transferred technology between process research, kilo lab, glass plant, and pilot plant. Scaled up synthetic chemicals directly in 22L, 100L and 200L vessels. Reactions included: oxidations, alkylations, cyclizations, coupling reactions, organometallic reactions, tosylations, and hydrogenations.
Confidential, San Diego, CA March 1996 to February 1998
Associate Scientist, Chemical Development
- Experience in providing alternative more cost effective synthetic routes to AG 1343 which are currently under large-scale trials. Skills in transferring technology from a bench level to pilot plant scale.
- Successfully optimized 9-step synthesis to prepare AG 1343 ( TM Viracept) a novel HIV protease inhibitor currently in production on multi-ton scale with an overall cost of goods savings between 20-25% over the previous synthesis.
Confidential, Nutley , NJ July 1990 to March 1996
Chemical Development Scientist
- Applied research and process development techniques in synthesis of vitamin derivatives for health, cosmetic, and industrial applications.
- Scaled-up and optimization of Vitamins and analogues, isolation of side reaction products impurity identification.
- Determined process parameters on laboratory scale. Scaled process from 22L flasks to 50-gallon reactor to 400-gallon reactor to 1,000-gallon reactor.
- Experience in large scale reactions requiring chlorinations, grignards, hydrogenations and metallations.
- Led team in development and scale up of HIV protease inhibitor and human growth hormone by solution phase peptide.
- Continuous improvement project to structure search used chemical inventory
References Available Upon Request