Job Title: Director of Quality, Cellular Therapeutic Group
Date Posted: 10-23-2007
Job Location: Massachusetts-Boston
Job Type: Full Time
Education Level: Masters Degree
Work Experience: 7+ to 10 Years
Job Shift: First Shift
Yearly Salary:DOE (Depend on Experience)
Company Name: Viacell
Contact Information: Viacell   Viacell (careers@viacellinc.com)
Job Description:
Director of Quality, Cellular Therapy Group
 

ViaCell is a cellular medicine company committed to developing the highest quality cellular
medicines for the effective treatment of cancer and cardiac diseases.  ViaCellís goal is to
provide pharmaceutical grade stem cells in sufficient quantities to enable widespread use of
cells as therapy.  ViaCell is achieving this goal through the application of its proprietary
cell expansion technology, known as Selective Amplification.  ViaCell also owns and operates
Viacord, a leading umbilical cord blood stem cell storage company that provides both financial
resources and access to cord blood stem cells, a key source material for the therapeutics
business.

 

With facilities in Massachusetts, the Cincinnati area, Germany and Singapore, ViaCell is
aggressively expanding its cord blood banking service, developing new cellular medicines, and
has initiated the first clinical trial using its patented technology for the expansion of stem
cells.  We seek imaginative thinkers who are ready for an exciting, entrepreneurial
environment, who thrive in a fast-paced workplace, and who want to contribute to a highly
motivated, success-driven team.

 

Responsibilities:

Reporting to the Vice President of Regulatory Affairs and Quality Systems

Manage and provide vision and leadership to quality assurance and quality control for the
cellular therapeutic group in a growing organization
Quality Control
Oversee all testing performed by the QC department to include
Experience in clean room procedures and aseptic processing
Experience in routine quality control testing (sterility, endotoxin, etc)
Experience in PCR, flow cytometry and bioassays
Oversee all raw material testing and release activities
Interact with Process Development, Analytical Biology and Science organization to evaluate and
integrate testing methodologies into QC
De novo, evaluate and integrate rapid analytical methods for cell therapy products
Transfer out of house testing to in-house resources
Support and oversee all assay qualification and validation activities
Oversee consolidation of QC practices and procedures for harmonization of materials management
between Massachusetts and Kentucky locations
Interact with and support Clinical Production for investigational biological products
Consulting support, as appropriate, to VPL
Quality Assurance
Oversee cGMP systems to include change control, vendor qualification, records management,
equipment/process/computer validation, training and competency program and documentation,
internal and external audits, SOPs, process improvement, change control and data review
support for the Kentucky commercial operations
Manage the Metrology and Facility Support program
Manage contracts and relationships with outside testing laboratories, contract manufacturers
and other vendors
Advocate and implement any necessary changes to keep ViaCell Therapeutics in compliance with
applicable regulations and guidelines
Develop, manage and communicate quality plans and goals for projects and ensure completion
Act as primary liaison for the research and development team pertaining to quality matters
generally
Interview and select new employees within the Quality Department and in the organization as
appropriate 
Provide training as needed for staff and ViaCell employees
Manage and mentor employees in all the above areas
   Requirements:

PhD (or Masters plus equivalent) experience in a Microbiology / Cell or Molecular Biology with
8 to 12 years of quality assurance and quality control experience in the biopharmaceutical
industry
Demonstrated ability to lead and influence others with 5 years experience in a direct
managerial role
Experience in the development of validation procedures and maintenance of quality systems.
Ability to think intuitively and problem solve
Experience with GMP manufacturing for clinical trials.  GTP knowledge a plus.
Ability to develop and maintain a strong quality team
Excellent communication across all organizational levels
Ability to objectively evaluate processes and procedures
Ability to successfully manage difficult/challenging situations with the potential to impact
product quality
Ability to develop productive process evaluations and improvements
Publications experience a plus
 

Additional Information:

This position is located in Cambridge, MA and depending on hire date, will be expected to
periodically travel to Worcester, MA in support of clinical trial production.  This position
will make occasional (not more than 1 per quarter) trips to the commercial production facility
in Kentucky.

 

Viacell offers a generous compensation package that includes, base salary, bonus, stock as
well as a comprehensive benefits package that includes: medical, dental, and disability
insurance as well as three weeks paid vacation, 401K plan, and access to a company subsidized
health club right next door.  We are conveniently located within easy walking distance of the
Kendall Sq/MIT stop on the Red Line; in addition we offer generous discounts for garage
parking and commuter costs.  

 

Send Resumes to: careers@viacellinc.com
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