Bioinformatician

 

Job Purpose:

The Bioinformatician is responsible for supporting the Product Support department; 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,  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.

 

Essential Duties and Responsibilities:

• Completing  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
• Follows all  Agendia health and safety policies and procedures
• Performs other related duties as required or assigned

 

Contacts

Internal:

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

 

External:

• External collaborators
• Scientific community

 

Education and Experience:

Education

Bachelors degree in life science or (bio-) informatics with a  strong background in cancer genetics/molecular biology and bioinformatics

Experience

• 1-3 years commercial, clinical and scientific experience.
• Technical product expertise with various diagnostic products and technologies.
• Microarray data analysis experience
• Programming experience (preferably Matlab or R)
• A background in medical biology or statistics preferred
• 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 Requirements:

No specific requirements

 

Knowledge, Skills, and Abilities (KSA’S) 

Specific Knowledge Required:

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:

• Honesty
• Reliability
• Discretion and loyalty
• Confidentiality
• Initiative

 

Language Skills Required:

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 Skills Required:

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.

Physical Demands:

Must be able to lift 10-25  pounds up to 25% of the time

 

Vision:

No special vision requirements (I.e. ability to read a computer monitor, view hard copies of documents, etc.)

 

Noise:

Moderate noise (little exposure to excessive noise)

 

Working Environment:

Office environment adjacent to a laboratory – employee is responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health-related problems and assist in solving safety and health problems. Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process. Complies with all safety policies of Agendia technologies World-Class Safety program. Follows appropriate procedures for biohazardous/radioactive/hazardous waste disposal. Takes responsibility for proper notification of any perceived safety.

 

OSHA Risk Category:

Category I – tasks which involve exposure to blood, body fluids, tissues, or blood borne micro-organisms.

 

Job descriptions will be reviewed intermittently; duties and responsibilities are subject to revision at any time, depending on business necessity.