RESPONSIBILITIES:
The Product Support Supervisor is responsible for managing the Product Support department in the United States; is responsible for the organization, advising and analysis of product support projects related to released products on the market (including laboratory / bioinformatics, related software, raw material qualification, product improvements, and process improvements). Supports sales and marketing, business development, IP, regulatory and medical affairs as well as lab operations within Agendia with the ultimate goal to improve patient care through improvement and stability of released personalized diagnostic tests.

• Leading assigned projects within Product Support
• Responsible for internal reporting of product support related projects
• Actively participate in multi disciplinary teams that cover biomarker discovery to release of new products
• Develop solutions to problems where established theories and techniques have not always been identified
• Initiate and perform analyses (of gene expression data) for process and product improvements
• Maintaining a good level of documentation and compliance with regulatory bodies (FDA, ISO etc)
• Responsible for transfer of assigned new products to operations
• Responsible for validation of assigned process improvements
• Responsible for validation of assigned product improvements
• Responsible for assigned equipment validations
• Responsible for assigned algorithm/software validations
• Responsible for CLIA validations (US lab)
• Follows all Agendia, Inc.'s health and safety policies and procedures
• Performs other related duties as required or assigned

RESPONSIBILITIES:

• Supervises Product Support group in USA

CONTACTS:
Internal:

• Research and development team
• Lab Operations department
• Project management
• Sales and marketing
• Medical affairs
• Regulatory affairs

External:

• External collaborators
• Scientific community

REQUIREMENTS:
EDUCATION:

• Doctoral degree (Ph.D.) in life science or (bio-) informatics with a strong background in cancer genetics/molecular biology and bioinformatics

EXPERIENCE:

• 7-9 years commercial, clinical and scientific experience
• Technical product expertise with various diagnostic products and technologies
• Extensive microarray data analysis experience
• Extensive programming experience (preferably Matlab or R)
• A background in medical biology or statistics would be a definite advantage
• Strong interpersonal skills, strong communications skills both verbal and written
• Excellent project management, time management and people skills together with a sense of urgency to resolve customer issues quickly and accurately
• International network within the academic and diagnostic industry

Certificates and Licensure:
No specific requirements

KNOWLEDGE, SKILLS AND ABILITIES (KSA'S):

SPECIFIC KNOWLEDGE REQUIRED:
Advanced knowledge of concepts and practices with the ability to use in diverse business situations:

• Computer skills/ software knowledge (Windows, MS Office)
• Programming skills (preferably Matlab and or R)
• Database skills (Oracle, Access)

Behavioral skills:

• Flexibility, to juggle the tasks that have to be completed and in working extra hours if deadlines are suddenly imposed
• Honesty
• Reliability
• Discretion and loyalty
• Confidentiality
• Initiative

LANGUAGE REQUIREMENTS:

• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community
• Ability to write speeches and articles for publication that conform to prescribed style and format
• Ability to effectively present information to top management, public groups, and/or boards of directors

MATHEMATICAL REQUIREMENTS:

• Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory
• Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems

REASONING ABILITIES:

• Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems
• Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.) in its most difficult phases
• Ability to deal with a variety of abstract and concrete variables

LOCALE:
Orange County CA-Irvine

COMPENSATION:
Commensurate with experience

HOW TO APPLY:
Forward CV's to dana.larosa[at]agendia.com