Expert Science & Technology, Analytical Development, Potency and Flow

Quick Facts

• Onsite; 5x week
• Location: East Hanover, US
• Visa sponsorship: not available
• Relocation support: not available

Description

Bench to bedside role serving as an Expert Science & Technology to develop, optimize, and implement novel analytical methodologies for CAR-T cell therapy products. The position supports potency and flow by participating in analytical method development, qualification, and method transfer, and may execute analytical assays to understand/characterize product function.

The candidate will interface regularly with Process Development, Quality Control, and Manufacturing Sciences & Technology to collaboratively drive projects to meet timelines while maintaining high quality and data integrity standards.

Responsibilities

• Plan, organize, perform, and document scientific experiments under moderate supervision
• Perform analytical testing including flow cytometry and cell-based bioassays (cytokine release, cytolytic activity, proliferation) following appropriate SOPs and procedures
• Review and approve data generated by other team members
• Record and maintain meticulous electronic laboratory notebook entries in compliance with quality standards
• Identify opportunities for method improvement and execute analytical method optimization
• Drive project timelines and deliverables while meeting internal quality and data integrity requirements
• Communicate effectively and present complex data within the department and cross-functionally
• Author and review method-related technical documents for completeness, accuracy, consistency, and clarity
• Support lab management including inventorying, clinical sample cryopreservation, and sample management

Requirements

• BA/BS or MS in biology, chemistry, biochemistry, microbiology or other related science
• Minimum 3 years of prior experience in industry or academia
• Knowledge of scientific principles underpinning cellular-based analytical methods including ELISA and cell-based assays
• Expertise in aseptic technique and mammalian cell culture including suspension cells (human T-cell culture is a plus)
• Ability to communicate clearly with cross-functional teams
• Detail-oriented with strong problem-solving and decision-making
• Ability to work in a regulated environment
• Good presentation skills and scientific/technical writing skills
• Demonstrated ability to work collaboratively within a large team and individually
• Preferred: experience writing laboratory SOPs and technical instructions
• Plus: experience with GMP

Benefits

• Performance-based cash incentive
• Depending on role level, potential eligibility for annual equity awards
• Comprehensive health, life, and disability benefits
• 401(k) with company contribution and match
• Time off package including vacation, personal days, holidays, and other leaves