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Sr. Manager/Assoc. Director, Quality Assurance

Cellerant Therapeutics, Inc.

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Location: San Carlos, CA Posted Date: 4/17/2013 Position Type: Full time Job Code: SH12013 Required Education: Bachelors Degree Areas of Expertise Desired: Biology
Cell Biology
Quality Assurance

Description

Cellerant Therapeutics, Inc. is a product focused biotechnology company with a portfolio of development stage programs based on the regulation of the hematopoietic (blood-forming) system.  The Company focuses on human stem cell and antibody therapies for oncology applications and blood-related disorders.  Cellerant is developing a novel, cell-based medicine (Myeloid Progenitors) as a treatment for chemotherapy- and radiation-induced neutropenia (CLT-008) as well as for Acute Radiation Syndrome.  The antibody program is focused on discovering novel therapeutic antibodies aimed at cancer stem cells.  Cellerant has been awarded multiple grant/contract awards from the government towards the development of our key programs.

Position Summary:
The Sr. Manager/ Associate Director of Quality Assurance will provide risk-based quality oversight to the internal and external customers at Cellerant.  The incumbent will lead the GMP and GLP operations, from a Quality perspective, and oversee CMOs/CROs while ensuring timely resolution of issues and adhering to project timelines.

Principal Responsibilities:
• Lead the GMP and GLP operations at Cellerant, from a Quality perspective.
• Provide support for Manufacturing, Development, Non-Clinical and other internal departments to ensure GMP/GLP compliance and adherence to Cellerant procedures.
• Attend multi-disciplinary team meetings as a Quality lead.
• Support the selection and management of third-party service providers (e.g., contract manufacturers, testing laboratories, contract research organizations) and ensure expectations for quality and compliance are documented and met.
• Assist in development, implementation and maintenance of quality systems for lot release, training, tracking discrepancies, investigations, audits, change control, etc.
• Ensure appropriate excursion resolution and manage the lot release activities for GMP manufacturing.
• Assist in hosting regulatory site inspections and coordinating responses to findings.

Requirements

Qualifications:
• At least 10 years of pharmaceutical or biotechnology experience in aspects of quality assurance and quality control, preferably with biologics and/or cell based-therapeutics.
• Bachelor of Science or higher degree in a relevant scientific discipline.
• Very knowledgeable in GMP and GLP compliance regulations and industry practices, with a background that includes outsourced contract manufacturing and testing.
• Well-organized and detailed oriented with good verbal and written communication skills.
• Willingness to travel approximately 20% of the time.

Please submit your CV and cover letter to: hr@cellerant.com

Cellerant is an Equal Opportunity Employer, committed to hiring the best qualified individuals and giving them the opportunity to stretch their abilities. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin. We offer a competitive compensation and benefits package.

Cellerant provides a goal-oriented environment that fosters innovation, professionalism and open communication.  While taking ownership of their specific area of responsibility, employees contribute to the shared goals of a multi-disciplinary team in a dynamic, participative environment.
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