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Biologics Consulting Group, Inc.
is pleased to make the following announcement:
Lourdes Bermejo, MS, joined the Biologics Consulting Group, Inc. (BCG) in October 2007 as Senior Consultant, in our North Carolina Office.
Ms. Bermejo has roughly 15 years of experience in FDA-regulated industries in Process Development, Technology Transfers, Engineering, Manufacturing and Validation. She is a professional with an extensive track record of achievement and successful leadership across multidisciplinary fields.
Ms. Bermejo was most recently the Senior Manager of Process Engineering at Biolex Therapeutics, a biopharmaceutical company involved in the development and production of therapeutic proteins using the aquatic plant Lemna. She played a pivotal role in the development of innovative production platforms, as well as, the improvement of processes through integration of process development, scale-up and facility design.
Other positions include the Integrated Commissioning Validation (ICV) Manager, at the Wyeth Grange Castle Campus (Ireland) where she played a key role in the largest start-up at the time in the Biotech Industry. Responsibilities included the preparation of Commissioning test documents, Installation (IQ), Operation (OQ) and Performance (PQ) Qualification protocols for the equipment of a large-scale, commercial production Cell Culture plant (API). Additionally, she oversaw deviation resolution, post-execution review and protocol close-out.
Ms. Bermejo was Associate Director of the Operations department at Diosynth-RTP, a contract biotechnology manufacturing organization (CMO) for drug substances. Ms. Bermejo provided expensive technical leadership in the area of process development, scale-up, technology transfer and manufacturing. She was responsible for multiple projects within the constraints of aggressive timelines and a fast paced cGMP regulated environment. These included start-up of the Cell Culture department for production of clinical, late-phase material in record times and with the highest success rate in the company at the time.
Earlier roles involved leadership positions in the development and optimization of fermentation processes for which she was responsible for experimental designs, as well as, all aspects of small scale toxicology / early clinical upstream runs.
Ms. Bermejo has an undergraduate degree in Chemistry and a graduate degree in Chemical Engineering.
At BCG Ms. Bermejo will use her experience and knowledge to assist clients in:
- Management
of Start-Up's and Production Campaigns (Drug Substance) - Contract
Manufacturing
- Technology
Transfers
- Process
Development, Scale-Up. Fermentation / Cell Culture
- Problem
solving
- Process
Optimization
- Investigations/Deviation
Resolution
- Validation
program development
- Facility
start-up planning and design review
- PAI
preparation
View
Ms. Bermejo's Curriculum Vitae...
Page Updated June 16, 2008