— Progenitor Cell Therapy

From Bench to Market: Advancing the Field of Cellular Therapy

Our quality product service solutions bridge the gaps between technology and patient care by providing custom-tailored cell therapy services, including:

Contract Manufacturing
Product & Process Development
Consulting
GTP Services
National Distribution

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	DATE – 06/22/2008 POST – Process Development Scientist LOCATION – Mountain View, CA
	Position type: Full time Job Code: 0022 Required education: Bachelor's Degree Area(s) of expertise desired: Cell Biology, Process Development Description Will be responsible for: Technology transfer of processes from client companies into PCT facilities and as necessary vice versa; Scale-up and further development of processes transferred from clients, including yield optimization, cost of goods reduction, media optimization and improvement of regulatory compliance; execution of final product formulation development strategies; Execution of raw material, in-process intermediate and final product stability programs; supervising the activities of development associates in the R&D laboratories; On- and off-site consulting and technical assistance for clients with cell process development methods and cell processing equipment installation and operation; Evaluation of new cell processing equipment, technology and methods for PCT-specific, client-specific or general cell therapy applications; Compilation of development SOPs and development process production records; Preparation of technology transfer protocols, process development protocols, stability study protocols and development process qualification protocols; Preparation of final reports for executed technology transfer protocols, process development protocols, stability study protocols and development process qualification protocols; development and implementation of protocols for training of PCT staff in manufacturing processes; and Provision of hands-on technical training to attendees at PCT or collaborative workshops Requirements The position requires a minimum BS degree in Biology or Biochemistry. The ideal candidate has post-graduate education and a minimum of 5 years of relevant experience in development and manufacture of cell-based therapeutics, cell culture-based biopharmaceuticals, or an equivalent combination of education and related experience. Expertise in cell manufacturing process development and qualification, aseptic technique and experience operating and maintaining cell processing equipment, including bioreactors, Cell Factories, COBE Cell Processors, Cytomate Cell Processors and magnetic separation systems are additional requirements as are good oral communication skills, detail orientation, problem solving ability and teamwork. A willingness to work flexible hours and shifts is important

DATE – 06/22/2008
POST – Process Development Scientist
LOCATION – Mountain View, CA

Position type: Full time

Job Code: 0022

Required education: Bachelor's Degree

Area(s) of expertise desired: Cell Biology, Process Development

Description

Will be responsible for:

Technology transfer of processes from client companies into PCT facilities and as necessary vice versa;
Scale-up and further development of processes transferred from clients, including yield optimization, cost of goods reduction, media optimization and improvement of regulatory compliance; execution of final product formulation development strategies;
Execution of raw material, in-process intermediate and final product stability programs; supervising the activities of development associates in the R&D laboratories;
On- and off-site consulting and technical assistance for clients with cell process development methods and cell processing equipment installation and operation;
Evaluation of new cell processing equipment, technology and methods for PCT-specific, client-specific or general cell therapy applications;
Compilation of development SOPs and development process production records;
Preparation of technology transfer protocols, process development protocols, stability study protocols and development process qualification protocols;
Preparation of final reports for executed technology transfer protocols, process development protocols, stability study protocols and development process qualification protocols; development and implementation of protocols for training of PCT staff in manufacturing processes; and
Provision of hands-on technical training to attendees at PCT or collaborative workshops

Requirements
The position requires a minimum BS degree in Biology or Biochemistry. The ideal candidate has post-graduate education and a minimum of 5 years of relevant experience in development and manufacture of cell-based therapeutics, cell culture-based biopharmaceuticals, or an equivalent combination of education and related experience.

Expertise in cell manufacturing process development and qualification, aseptic technique and experience operating and maintaining cell processing equipment, including bioreactors, Cell Factories, COBE Cell Processors, Cytomate Cell Processors and magnetic separation systems are additional requirements as are good oral communication skills, detail orientation, problem solving ability and teamwork. A willingness to work flexible hours and shifts is important

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