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Susan M. Rowe, M.T. (ASCP).
Susan M. Rowe, is Director of Analytical R&D at QS Pharma.
She is responsible for providing leadership to Analytical
R&D with responsibilities that encompass: -method development,
validation and testing of active pharmaceutical ingredients
(API), excipients and packaging components, drug products,
GLP concentration verification and cleaning verification
-stability study design, management and testing for API,
drug products, and GLP study formulations -preformulation
evaluations Prior to joining QS Pharma, Ms. Rowe spent 17
years at The DuPont Pharmaceutical Company (now Bristol-Myers
Squibb) in the Pharmaceutical R&D Department in roles of
increasing responsibility. During her industrial career,
Ms. Rowe has been involved in various product development
projects and has led streamlined first in man studies and
discovery support efforts in various therapeutic areas.
Ms. Rowe received her Bachelor of Science degree in Medical
Technology from Neumann College. Ms. Rowe has 16 publications
and 14 presentations. She is a member of American Association
of Pharmaceutical Scientist (AAPS).
Contact: Susan
M. Rowe, M.T.(ASCP)
Robert L. Alfred,
M.Sc.
Bob Alfred is
the Director of Environment, Health and Safety at QS Pharma. With twenty four
years of experience in the EHS field, Bob's background includes extensive
work in the pharmaceutical field and. environmental consulting. Mr. Alfred
served as the industrial hygienist for the Bristol-Myers Squibb-Wilmington
Area sites (formerly DuPont Pharmaceuticals Company), and as an EHS generalist
for Wyeth-Ayerst Pharmaceuticals. Mr. Alfred received his Bachelor of Arts
degree in Biology from the University of Maine in Farmington, Maine and his
Master of Science degree in Environmental Health from West Chester University
in West Chester, Pennsylvania. He is a full member of the American Industrial
Hygiene Association, American Board of Industrial Hygiene and the Industrial
Society of Pharmaceutical Engineers.
In addition to
his experience, he has presented numerous training programs to employees,
supervisors and management on safe working strategies for potent compounds
and has presented a paper entitled "Designing a Potent Compound Manufacturing
Suite" at the DuPont Potent Compound Handling conference in 2000.
Balu Balakrishnan,
Ph.D.
Balu Balakrishnan
is the Director of Quality Assurance of QS Pharma. Before he joined QS
Pharma, Dr. Balakrishnan was Manager, Pharmacy Informatics Applications at
Bristol-Myers Squibb Pharma Company (formerly DuPont Pharmaceutical Company).
He worked as a software engineer at HTI Voice Solutions, Inc., Marlborough,
MA. Before moving to Information Technology, Dr. Balakrishnan worked as a
Senior Scientist at BioTechnica International, Inc., Cambridge, MA.
Dr. Balakrishnan
is experienced in computer system and software application validation, software
application development, database management. He received his Ph.D in Molecular
Biology from Madurai Kamaraj University, India. He has undergone training
in software development at Worcester Polytechnic Institute, Worcester, MA
and at Penn State University, Great Valley, PA.
Balu Balakrishnan,
Ph.D.
Balu Balakrishnan received his Ph.D in Molecular Biology from
Madurai Kamaraj University, India. He has undergone training in
software development at Worcester Polytechnic Institute, Worcester,
MA and at Penn State University, Great Valley, PA.
Warren Cook, PHR
Warren is responsible for all Human Resources Management activities at QS Pharma.
Warren is a Certified Human Resources Professional with fifteen years of diversified business experience
encompassing the Pharmaceutical, Healthcare, Manufacturing, and Insurance industries, in both internal
and external strategic roles. His career has been focused on the Human Resources function as a strategic
partner during the past seven years. Before joining QS Pharma, LLC Warren spent two years as a
Consultant for Noramco, Inc, an affiliate of Johnson & Johnson in Wilmington, DE, one year with
Cardinal Health PTS in Philadelphia, PA as an HR Generalist, and two and a half years at
GlaxoSmithKline’s Philadelphia, PA headquarters in corporate shared services EEO & Compliance department.
Warren has significant experience in the development and implementation of strategic human resource
initiatives, business relationships, organizational development and alignment, policies and practices,
strategic planning, change management, leadership coaching, project management, AA & EEO, federal/state
compliance issues, employee relations and investigations, full life cycle recruitment, audits,
data collection and analysis, and training. Warren is a national member of the Society for Human
Resources Management (SHRM) and the Delaware Chamber of Commerce.
Stuart L. Culp,
PE
Stuart L. Culp,
PE is the Director of Validation and Engineering at QS Pharma. Mr. Culp was
Senior Validation Engineer of GMP Operations for Bristol-Myers Squibb Pharma
Company (formerly DuPont Pharmaceuticals Company). Stuart began his career
as an engineer for Raytheon Engineering in 1989. He joined the Validation
Group of Raytheon Engineering in 1994 as a Validation Specialist. In 1995,
he was awarded Raytheon's "Performance Award" for field work in Validation.
Stuart joined DuPont Pharmaceuticals in 1997 as a Validation Engineer. He
was awarded the DuPont Pharmaceutical's R&D "Quality Award" for improvements
to the Cleaning program. Stuart was promoted subsequently to Senior Validation
Engineer in charge of Validation, Calibration, Cleaning, and Coordinator of
GMP Area activities for the Pharmacy R&D division of DuPont Pharmaceuticals.
Mr. Culp also worked briefly for Day & Zimmermann in 2002 as Project Leader.
Nutan K. Gangrade,
Ph.D.
Nutan K. Gangrade,
Ph.D. is responsible for formulation development and manufacture of clinical
supplies at QS Pharma. Before joining QS Pharma as the Director of Formulation
Development, Dr. Gangrade was Principal Research Scientist at Pharmaceutical
R&D Department of the Bristol-Myers Squibb Company (formerly DuPont Pharmaceuticals
Company). Dr. Gangrade earned B. Pharm. and M. Pharm. (Pharmaceutics) degrees
from Banaras Hindu University, India and Ph.D. (Pharmaceutics) from University
of Georgia in 1991. He then joined Chase Pharmaceutical Company as a Development
Scientist. Subsequently, he worked as Research Scientist and Senior Research
Scientist at Wyeth-Ayerst Research (formerly American Cyanamid Company) until
joining Dupont Pharmaceuticals Company. During his industrial career, Dr.
Gangrade has been involved in various product development projects and has
led CMC development teams in various therapeutic areas. Dr. Gangrade has six
publications, thirteen presentations and one patent application. He is a member
of American Association of Pharmaceutical Scientist (AAPS).
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