Experience

Immunomedics

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director, Validation & Compliance

  • Jul 2016 - Present

  Morris Plains, New jersey Responsible for directing the development and maintenance of the Validation and Calibration Programs. Provides technical support to the operations departments to meet compliance requirements. Troubleshoots equipment, processes, and system failures. Serves as the technical and quality lead for product technical transfers to contract manufacturers and the technical liaison between process development and commercial manufacturing. Works closely with the process development group to initiate and… Show more Responsible for directing the development and maintenance of the Validation and Calibration Programs. Provides technical support to the operations departments to meet compliance requirements. Troubleshoots equipment, processes, and system failures. Serves as the technical and quality lead for product technical transfers to contract manufacturers and the technical liaison between process development and commercial manufacturing. Works closely with the process development group to initiate and perform studies supporting tech transfer and regulatory inquiries. Jointly responsible for the computer system validation (CSV) in conjunction with IT. Develops, trains, mentors, and coaches validation staff. Notable Achievements: • Served as the technical lead of the Core team involved in the technology transfer of Phase III/commercial processes to contract manufacturing organizations (CMOs). • Led the site-wide initiative for a Pre-Approval Inspection (PAI) for assigned workstreams. • Managed the implementation of the electronic document and quality management systems (eQMS & eDMS), from the initial selection through to configuration, testing, validation, and migration. • Developed and implemented site-wide Validation Master Plans for cleaning, equipment, processes, utilities and analytical methods, ensuring that the manufacturing site is constantly maintained in a state of validation. • Oversaw the upgrade and validation of the manufacturing facility, including the design, installation, and validation of a new washer, sterilizer, and supporting utilities. • Writes, revises and reviews relevant CMC sections for regulatory submissions, and works with process development in identifying, executing and creating studies required to support regulatory filings. • Represents the company as the compliance/quality liaison for regulatory authorities, corporate partners, and other entities as required.

• Director, Quality Assurance & Compliance

  • Mar 2014 - Jul 2016

  Morris Plains, New Jersey Responsible for site quality project management, quality assurance, compliance and validation functions. Directed the quality systems for the corporate site and the quality assurance activities relating to manufacturing, testing, and release of raw materials and clinical products. Managed the precise and complicated process of the labeling, shipping, and distribution of a global clinical Phase III trial. Directed a variety of systems for the Corporate site such as investigations, audits… Show more Responsible for site quality project management, quality assurance, compliance and validation functions. Directed the quality systems for the corporate site and the quality assurance activities relating to manufacturing, testing, and release of raw materials and clinical products. Managed the precise and complicated process of the labeling, shipping, and distribution of a global clinical Phase III trial. Directed a variety of systems for the Corporate site such as investigations, audits, vendor qualifications, inventory management and more. Notable Achievements: • Researched, validated and implemented single-use bioreactors for the mammalian cell culture, which the company had previously never used. • Established and maintained Corporate Quality Systems to ensure compliance with regulations governing drug development and clinical studies. • Reduced the batch release cycle time from 12 weeks to 4 weeks by identifying process improvement elements, such as cross training. • To meet increased product demand, led the transition of manufacturing to a contract manufacturer, ensuring quality assurance and compliance. • Directed and developed a team of professionals who were responsible for the release of aseptic parenteral forms for Clinical Investigational Medicinal products. • Represented the Company as compliance/quality liaison for regulatory authorities, corporate partners, and other entities as required.

• Senior Manager, then Director, Validation & Technical Services

  • Jul 2009 - Feb 2014

  United States Continuously reviewed and improved the company’s validation philosophy, practice, and procedures. Managed the validation team, while ensuring compliance with all regulations. Directly supervised validation engineers and technicians. Controlled, managed and monitored the CMC, quality, regulatory compliance and risk management of the manufacturing process. Assessed process capabilities, identified and challenged critical process parameters, optimized processes, and developed protocols. Assisted… Show more Continuously reviewed and improved the company’s validation philosophy, practice, and procedures. Managed the validation team, while ensuring compliance with all regulations. Directly supervised validation engineers and technicians. Controlled, managed and monitored the CMC, quality, regulatory compliance and risk management of the manufacturing process. Assessed process capabilities, identified and challenged critical process parameters, optimized processes, and developed protocols. Assisted with the technological transfers of new products or processes. Notable Achievements: • Designed, developed, and executed validation protocols. Reviewed and approved engineering change controls, plant validation protocols, and reports, and managed the revalidation/certification and calibration programs. • Developed and maintained site-specific validation master plans for equipment, processes, and cleaning. • Became a subject matter expert in humanized monoclonal antibody and antibody fragment purification processes with active participation in process development, engineering studies, scale-up, and technology transfer for Phase II/III and commercial Tech transfers. • Participated in several FDA and international regulatory inspections as well as partner audits. • Evaluated and corrected process performance discrepancies and other issues in support of manufacturing operations. Investigated delays, trends, equipment issues and items that adversely impacted product capabilities.

• Asst. Manager, then Manager, Validation

  • Aug 2003 - Jun 2009

  Morris Plains, New Jersey Managed the validation of systems, computers, processes, manufacturing and laboratory equipment, including the preparation of protocols, performance testing, collection of samples, analysis of test results and the preparation of summaries. Provided ongoing manufacturing support, troubleshooting, non-conformance resolution, and process monitoring. Responsible for the company’s calibration program, developing relevant SOPs, supervision, and training of calibration personnel. Developed and… Show more Managed the validation of systems, computers, processes, manufacturing and laboratory equipment, including the preparation of protocols, performance testing, collection of samples, analysis of test results and the preparation of summaries. Provided ongoing manufacturing support, troubleshooting, non-conformance resolution, and process monitoring. Responsible for the company’s calibration program, developing relevant SOPs, supervision, and training of calibration personnel. Developed and executed validation protocols for production processes.



Enzon Pharmaceuticals

• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Validation Engineer

  • Dec 2001 - Aug 2003

  United States Qualified and validated the pharmaceutical cGMP facility, utilities, equipment, and control systems. Coordinated and managed all calibration activities for the site. Acted as validation representative on project teams and worked across departments to ensure that current industry guidelines and practices are implemented.



Schering-Plough Research Institute

• United States
• Pharmaceutical Manufacturing
• 400 - 500 Employee

• Chemical Engineer

  • Sep 2000 - Dec 2001

  United States Assisted with upgrading and validating an API manufacturing facility. Applied design and optimization of in-house technologies, designed support of proprietary equipment, provided plant check out and start-up support, and continuous process improvements. Performed validation projects, including authoring protocols, executing validation protocols, and writing reports of validation results.