Bioanalytical Development Scientist II

Job Description

Job Summary:

• The Scientist II position is a technical and managerial position.
• The primary responsibilities include:
• Lead an inter-department project or initiative involving other contributors.
• Design and execution of innovative scientific experiments for development, validation and implementation of robust bioanalytical methods on various technology platforms in clinical and nonclinical study samples.
• Develop and implement new and Client protocols to address specific issues and/or troubleshoot and improve current existing assay platforms towards being more robust and transferable.
• The position also requires critical thinking skills with an ability to integrate data and information to solve complex problems to advance drug discovery and development programs.
• Effectively be able to communicate complex ideas to audiences with varying degrees of knowledge.

Duties and Responsibilities:

• Function as a subject matter expert in the area of Bioanalytical method development adhering to GLP/GCP guidelines
• Drive the bioanalytical innovation by improving the quality and efficiency of method development and lab operation
• Serve as part of the BA sub-team, working with Bioanalytical project lead to support discovery or development projects for method qualification/validation, data reporting, and interpretation of issues associated with the bioanalytical results
• Transfer qualified and fit-for-purpose assays to CROs and serve as the primary point of contact for assay transfer and troubleshooting of technical assay issues within project specified timelines
• Integrate quality standards to ensure that bioanalytical data is fit-for-purpose (e.g. GLP compliance at CROs for regulated analyses)

Qualifications:

• Ph.D. in Life Sciences or related field with 8 years of relevant laboratory experience or Bachelors/Masters degree in relevant scientific discipline with 15+ years relevant laboratory experience
• Good understanding of bioanalytical assay development, validation, and associated data analysis
• Working knowledge of regulatory guidance documents that pertain to the bioanalytical discipline
• Experience with immunoanalytical methods, LCMS based methods and cell culture technique based assays for discovery support
• Experience performing method development using Design of Experiments (DOE) and lab automation
• Experience in organizing and managing multiple bioanalytical projects in the laboratory setting
• Scientifically independent – design, execute, analyze, interpret results, and reaches correct conclusions
• Well organized, motivated, team player, and works with a sense of urgency
• Experience in transferring assays to CROs, monitoring development/validation, and sample analysis
• Good writing and oral communication skills including good presentation skills
• Managing colleagues, working effectively in project teams and providing technical input to colleagues
• Can lead an inter-department project or initiative involving other contributors.

Competencies:

• Problem solving.
• Communication.
• Collaboration.
• Innovation.
• Self-motivation.
• Risk mitigation.

Physical Requirements/ Work Environment:

• Some duties of this role are conducted in an lab environment.
• As is typical of a lab-based role, employees must be able, with or without an accommodation to: lift/carry 15/30 pounds unassisted/assisted.
• Work comfortably in a controlled environment with and around biological, infectious, and hazardous materials.
• Gown/de gown PPE.
• Use a computer.
• Engage in communications via phone, video, and electronic messaging.
• Engage in problem solving and non-linear thought, analysis, and dialogue.
• Collaborate with others.
• Maintain general availability during standard business hours.

Interview:

• 2 round Virtual interview.