 Tim Joy
Beyond
serving as President of RMC, Tim assists clients with
creating, developing, and/or executing and achieving
their own measured solutions to both the individual and
interrelated compliance, quality and development responsibilities
of product development and commercialization programs.
Additionally, with contemporary hands-on experience evaluating
and monitoring GxP quality systems in Asia , North America
and Europe, Tim possesses a current global perspective
of precisely what is taking place to balance and achieve
the varied compliance, quality and overall drug development
objectives of numerous organizations throughout these
key regions.
 Scott Rudge
Since co-founding RMC Pharmaceutical Solutions
in May 2004, Scott has been involved in a wide variety
of projects for small and large biotech/pharmaceutical
companies. He has overseen and/or performed assay, equipment,
sterilization, cleaning and process validation, formulation
development, due diligence for a multimillion dollar
investment, construction of a new GMP facility for tissue
processing, and tech transfer for a major late stage
biotechnology product. In
his last position, Scott served as the Vice President
of Operations at FeRx Incorporated, overseeing manufacturing,
process and product development, analytical development,
formulation, facility design, construction and operation,
and intellectual property.
 Raymond Nims
Raymond Nims brings over 35 years of experience in the
biomedical sciences. From 2006 to 2009, Ray served in
Amgen’s Corporate Quality Control group, providing subject
matter expertise in viral and mycoplasma testing of raw
materials and products, and serving as business process
owner for Amgen’s global contract analytical testing
lab outsourcing program. From 1994 to 2006, Ray directed
laboratories at BioReliance performing viral safety,
endotoxin, and cell line identity studies for biologics
cell line characterization, raw material testing, and
product lot release testing. From 1985 to 1994, Ray served
as a Chemist at the National Cancer Institutes’ Laboratory
of Chemical Carcinogenesis, and from 1974 to 1985 Ray
held a variety of technical and supervisory positions
at Microbiological Associates, a contract research organization.
Raymond obtained a PhD in Chemistry (Chemical Toxicology)
at The American University, Washington, DC, in 1993.
He currently serves on the editorial board for the International
Journal of Toxicology, and has served on the ad hoc advisory
boards for USP chapters 1237 and 1050. He is a generalist
in the Biomedical Sciences, with a publication list spanning
a wide range of areas in Chemistry, Carcinogenesis, Biochemistry,
Pharmacology, Toxicology, and Virology.
 Lori Nixon
Dr. Nixon has been with RMC since 2005, and has over 18
years of experience in the bio/pharma industry, with
a focus on analytical development and quality control. She
received her PhD in Analytical Chemistry from the University
of Colorado at Boulder and subsquently worked in Process
Development and Analytical groups at Synergen and Amgen,
Inc. She was formerly head of Analytical Sciences
at Amgen Colorado.
Since
joining RMC, Lori has worked with a variety of biotech
and pharma clients to develop and oversee analytical
and bioanalytical programs and activities including method
development, transfer and validation; stability; sampling
plans; formulation development; product specifications;
reference standards and critical reagents development;
laboratory audits and more. She has worked
with a variety of therapeutics including recombinant
proteins, monoclonal antibodies, oligonucleotides, synthetic
peptides and other small molecules and has worked with
products both in early (pre-IND) and late (post-commercial)
stages.
 Joanne
Izyk
Joanne Izyk brings over 15 years of experience to RMC and
its clients, predominantly in the pharmaceutical industry
– but also supplemented with direct horticultural and
science education experience as well. Immediately prior
to joining RMC, Joanne was Sr. Manager, QA/QC at FeRx
Incorporated where she was responsible for the daily
supervision and management of Quality Assurance and Quality
Control activities. The operations included internal
pharmaceutical manufacturing and testing, pharmaceutical
outsourced services and medical device components for
combination products.
Joanne’s overall hands-on experience bridges both commercial
and development-stage pharmaceutical companies. This
experience includes GxP Quality Systems development and
management, quality control performance and management
(including various chromatographic, wet chemistry & physical
testing techniques), analytical research and stability,
manufacturing operations oversight and support, technical
report writing, regulatory submission review and Laboratory
Information Management systems. Joanne also has wide-ranging
experience in both North America and Europe auditing
and monitoring GMP raw material/excipient suppliers,
contract manufacturing and testing operations (API and
Drug Product), and labeling/packaging/distribution suppliers.
Joanne earned her B.S. in Secondary Education/Chemistry
from the State University of New York at Plattsburgh.
Leah Choi
Since joining RMC Pharmaceutical Solutions in November 2006, Leah has been involved in various pharmaceutical and biotechnology projects such as: assisting with the execution of OQ/IQ protocols for a manufacturing clean room; writing standard operating procedures, protocols, and technical transfer documents; assisting in the development and manufacturing process for a pre-clinical drug product; executing QC/QA review of production batch records, raw analytical data, technical reports, stability reports, and regulatory filings; executing some project management tasks; assisting in the design, creation, and implementation of a quality system for a virtual biotech company; executing various document management tasks; and reviewing pipe and instrument drawings, requirement specifications, and functional specifications for a modular CIP system.
Prior to joining RMC, Leah attended the University of Colorado at Boulder, Boulder, Colorado and earned her B.A. in Biochemistry, with a minor in Chemistry. In 2009, Leah also received a Certificate of Good Laboratory Practices/Good Manufacturing Practices form the University of Denver, Denver, Colorado and a Yellow Belt Training Certificate from the Colorado Association for Manufacturing and Technology in Boulder, Colorado.
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