Scientist – II

Job Description

Job Summary:

• This specific position will support the molecular team, and the individual should have a comprehensive knowledge of the principles and concepts of molecular biology as it pertains to method development and sample testing.
• The successful candidate will evaluate new techniques, validate, and troubleshoot molecular assays and test pre-clinical and/or clinical samples as needed.
• Experience in Next Generation Sequencing is desired.

Duties and Responsibilities:

• Non-Client staff who work directly as a part of the Regulated Bio analytics (RegBA) team, and are reflected on the RegBA organization chart, that work under direct guidance of Client staff to support the regulated bioanalytical laboratories and Client pipeline through operational and/or scientific activities.
• This specific position will support the molecular team, and the individual should have a comprehensive knowledge of the principles and concepts of molecular biology as it pertains to method development and sample testing.
• The successful candidate will evaluate new techniques, validate, and trouble-shoot molecular assays and test pre-clinical and/or clinical samples as needed.
• Collaborates effectively with a variety of Client and non-Client staff to accomplish goals.
• Uses established procedures, technologies, and methodologies to complete bioanalytical assignments.
• Use of laboratory applications to perform bioanalytical tasks to track samples and/or reagent, equipment related information, document BA experimentation and conduct analysis (e.g. reagent inventory tools, data transfer, ELN, etc.).
• Operates under Client guidance to perform general tasks (e.g., sample check-in, equipment maintenance coordination, data transfers, method development, validation or sample testing, etc.).
• Participates in computer system validation activities and may be involved in the development and/or release of new or enhanced systems
• May participate on project or process improvement teams to drive enhancements.

Education and Experience:

• Associates degree with 6 years , or a BA/BS with 4-5 years or Masters degree with 2-3 years or PHD with 0-1 year of experience.
• Degrees may be in a variety of areas including the biological or chemical sciences, computer sciences, engineering, medical technology, etc.
• Experience executing routine molecular assays, data interpretation, and quality control techniques for technologies including NGS, nucleic acid extraction, qPCR/dPCR Ability to operate according to SOPs and safety principles.
• Experience with liquid handler technology to perform molecular biology assays is desirable.
• Experience in Next Generation Sequencing is desired.

Knowledge, Skills and Abilities:

• Demonstrate good documentation practices (GDP) in all forms of documentation.
• Basic knowledge of Windows based applications, laboratory equipment and systems required to perform job tasks.
• Understands and applies regulatory/compliance/scientific requirements relative to their role.

Personality:

• Strong organizational and project management skills.
• Demonstrates urgency and sensitive to meet project timelines.
• Proven experience thinking critically.