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Job Title: Sr Director - Development Process
Location: California
Discipline: Process
Reference: VUWK4413
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Description: Process Development/ Pharmaceutical / Product Development/ Contract
Manufacturing/ Quality / Compliance / regulatory /Chemistry/ Bio-Chemistry
VUWK4413
Sr Director - Development Process
Bay Area, CA
Sr Director - Development Process in the Pharmaceutical and
Device Development (PDD) will lead a technical organization of
engineers and scientists who will work in partnerships with external
companies in the development of delivery devices and combination
products the Company. Devices and combination products of
interest include but are not limited to prefilled syringes, auto-injectors,
pen injectors and cartridges, and/or novel injection devices and,
potentially, devices to enable alternative routes of delivery.
Major responsibilities will include leadership of the company's
device development strategy and implementation/ technical oversight
for all phases of design, industrialization/ commercialization of
the delivery devices / providing guidance and input to project teams
and sub-teams in the area of device and combination product
development, including integration with the full spectrum of drug
development activities. In addition the successful candidate
will also have major responsibility for aligning goals and
coordinating close collaborations with multiple internal partners and
functional areas for successful device and combination development in
the company's cross-functional and collaborative environment/partners
include formulation scientists process and packaging engineers,
the commercial franchises, contract manufacturing, quality and
compliance, product development, regulatory affairs, business development,
and others.
Qualifications: Experience/Skills/Education
The ideal candidate will have a Ph.D. in Engineering, Pharmaceutical
Sciences, Physical Chemistry, Biochemistry or the equivalent/ 17 years
experience in the Pharmaceutical industry is required, with at least 12
years of experience in device, combination product and/or pharmaceutical
development. The candidate must have deep expertise in delivery device
design, development, industrialization, and commercialization, combined with
a broad knowledge of manufacturing, quality control, preclinical and
clinical development, and regulatory issues pertaining to delivery devices
and combination products. Must have a proven track record of taking
delivery devices and/or combination products from conception to successful
implementation and commercialization; experience in the development of
injection devices is highly desirable. Must have experience managing groups
of engineers and scientists; and a proven track record of working
effectively in a matrix organization with a highly cross-functional and
collaborative environment is very desirable. Excellent people management,
communication, and influencing skills are required. Experience in managing
partnerships with external companies is also highly desirable.
Apply to: Click Here
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