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Manufacturing Head

ViaCyte, Inc.

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Location: San Diego, CA Posted Date: 4/25/2013 Position Type: Full time Job Code: 2013-4 Required Education: Bachelors Degree Areas of Expertise Desired: Cell Culture
Engineering
Manufacturing/Production

Description

ViaCyte, Inc. is a preclinical therapeutic company focused on diabetes.  Our therapy is based on pancreatic beta cell progenitors derived from human pluripotent stem cells.  These cells are implanted using a durable and retrievable encapsulation device.  Once implanted and matured, these cells secrete insulin in response to blood glucose levels.  Our goal is long term insulin independence without immune suppression, and without hypoglycemia and other diabetes-related complications.

The advancement of our development plan and related increase in manufacturing activities led to the creation of this new position.  This is an exciting time at ViaCyte and we invite you to explore this opportunity.

Duties

The head of manufacturing will lead the development, planning, implementation and maintenance of manufacturing methods, processes and operations for cell, device and combination products.   Primary duties will include identifying manufacturing strategies and goals, and determining resource and budgetary projections to meet these objectives.   Additional duties will include preparing documents and reports, and assisting with writing the CMC sections for regulatory submissions.  Other responsibilities will include hands-on management of the supply chain, inventory, and production planning, and direct and indirect supervision of device, cell, and combination product manufacturing personnel.  There will be key partnerships with the quality assurance and process development teams to ensure cGMP compliance through continuous improvements of quality systems, and ensuring that processes, raw materials, and equipment are qualified and validated for their intended uses.  When contract manufacturing or other outsourcing or in-sourcing arrangements are necessary, the head of manufacturing will oversee the execution of these engagements.  

Requirements

A college degree is required, with an advanced degree in the life sciences or engineering preferred. A minimum of 10 years of experience manufacturing medical technology products is required, with preference given to candidates with cell processing and/or implantable device backgrounds.  This experience should demonstrate an increasing level of managerial responsibilities in GMP-regulated commercial manufacturing operations.  An equivalent combination of education and experience sufficient to successfully perform the job duties will be considered.

A qualified candidate will possess strong leadership and managerial skills and the ability to function effectively in a highly collaborative environment.  The ability to foster teamwork and to influence others in the absence of direct authority is highly desired.  

Knowledge of cGMP and FDA regulations as they pertain to the job scope is required.  Strong verbal and written communication skills are a must.

Application Procedure

We prefer to receive your resume or curriculum vitae, with cover letter, via e-mail.  Please reference Job Code #2013-4 and your full name in the Subject line.  Our address for correspondence is ViaCyte, Inc.,     3550 General Atomics Court, San Diego, California, 92121. Visit our website for more information: http://viacyte.com/careers/
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