BARBARA DUHL-EMSWILER, PH.D.
EXPERIENCE & QUALIFICATIONS
Barbara Duhl-Emswiler, Director of bde
BioPharmaceutical Resources, has a Ph.D. in organic
chemistry from Michigan State University and over 19 years
experience in the pharmaceutical, biotech & medical
device industries. Prior to establishing bde
BioPharmaceutical Resources, she held scientific and
managerial positions at Johnson & Johnson, Berlex
Laboratories, ProCyte Corporation, and CDR Therapeutics.
Consulting projects with bde BioPharmaceutical
Resources have included:
Prepare detailed Scope of Work document for a process development project being outsourced
Review and edit development report, batch record, and
technology transfer protocols for sterile pharmaceutical
product
Audit contract manufacturing facilities (active
pharmaceutical ingredient & dosage form production)
Source & recommend clinical supplies manufacturers for a
peptide based vaccine product
Review process validation protocols for synthesis of active
pharmaceutical ingredients
Project planning for first IND filing of a new biotech
company
Write, review, and/or revise SOPs, analytical methods, and
product specifications
Assemble CMC sections for IND and NDA filings and assist
contract manufacturer in DMF preparation
Provide business development assistance to a pharmaceutical
contract manufacturer, including assessment of capabilities,
writing promotional materials, identifying potential clients
& products, and coordinating advertising & trade
show presence.
Dr. Duhl-Emswiler was the Director of Chemical Development
& Contract Manufacturing at ProCyte, where she was a key
member of the design team for two manufacturing facilities -
a 10,000 sq.ft. chemical plant for peptide synthesis and a
7,000 sq.ft. facility for producing polymer-based medical
devices. Her technical guidance, from design thru validation
& start-up, included process design, equipment
specification, GMP considerations, and waste disposal &
environmental planning.
Chemical Development responsibilities encompassed process
& analytical methods development, and clinical &
commercial manufacturing for drug substances, formulated
drug products & medical devices. For example:
Leading project teams responsible for initiating commercial manufacturing of peptide and polymer-based wound care products
Cost analysis and planning for manufacturing cost reductions
Sourcing raw materials and packaging components
Production planning
Preparing CMC sections for IND and NDA filings, and relevant sections of 510K applications for medical devices.
Under her direction, ProCyte established contract
manufacturing operations to provide GMP synthesis & bulk
lyophilization services to the the biopharmaceutical
industry. Her responsibilities included:
Business development: coordinate advertising, trade show presence, and direct mail campaigns to introduce the services and build client awareness.
Technical director ñ evaluate projects for technical & economic feasibility, primary liaison with client project managers, plan and coordinate production activities among ProCyte groups
Prior to joining ProCyte, Dr. Duhl-Emswiler was responsible
for setting up a peptide synthesis & analysis group at
Berlex Laboratories, and for developing commercial processes
for solution peptide synthesis as a Senior Scientist at
Johnson & Johnson.
As Director of Chemical Development at CDR Therapeutics,
she established the chemical development and peptide
synthesis functions for this new biotechnology company,
including:
Cost analysis assessment of commercial viability of potential drug substances
Design, staffing & cost-effectively equipping laboratories for peptide synthesis & analysis
Identification & evaluation of suppliers for scale-up & production of bulk peptides under cGMP, formulation development, and clinical dosage form manufacturing activities.
Community outreach
Barbara has participated for 3 years in a Telementoring for Young Women in Science & Engineering program. This is a pioneering program utilizing the internet to facilitate mentoring discussions, pairing high school girls with women active in science & engineering.
For more information about this program:
www.edc.org/CCT/telementoring/
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Issaquah, Washington 98027 |
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