Scientist II Bioanalytical Development

Job Title: Scientist II Bioanalytical Development
Location: New Haven | 100% onsite
Work type: ~70% lab / 30% office (lab-heavy role)
Contract duration: 12 months
Interview - 2 round Virtual interview

Position Summary
The Scientist II position is a technical and managerial position. The primary responsibilities include: (1) Lead an inter-department project or initiative involving other contributors; (2) 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; (3) 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.
Principal 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
• 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/degown 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

Education

• Ph.D., MS or BS degree in relevant biological science field

Competencies

• Problem solving

• Communication

• Collaboration

• Innovation

• Self-motivation

• Risk mitigation