Senior Scientist, Bioanalytical Development

The Role:

Life Edit is seeking a seasoned bioanalytical scientist with strong organizational, communication, and strategic skills, and the desire to be part of a highly collaborative and cross-functional team. The selected candidate will develop, execute, qualify, and validate/transfer assays as part of a highly collaborative and cross-functional team to quantitate and characterize Life Edit’s novel RNA-guided nucleases (RGNs) and gene editing programs as they move from research through to preclinical evaluation and eventual clinical advancement

Here’s What You’ll Do:

• Develop, qualify, and validate (as appropriate) bioanalytical assays (expressions assays including mRNA and protein [ELISA/IHC], anti-AAV capsid nAb, CTL IFN-γ ELISPOT, IgG/IgM, biodistribution and shedding) for all programs and define science-driven, phase appropriate, and risk-based analytical development strategies to support the development candidate during discovery through preclinical evaluation (including GLP) and clinical development advancement
• Ensure adequate rigorous laboratory practices in a regulatory ready research manner
• Represent Bioanalytical Development on project teams
• Evaluate, interpret, and compile bioanalytical data into study reports for regulatory filing
• Critically summarize and present data internally to interdisciplinary teams as well as externally
• Write SOPs for analytical methods, protocols and reports and provide training on process and equipment

Requirements:

• PhD in chemistry, biology, biochemistry, or related life sciences field with at least 5+ years of relevant experience or MS with at least 12+ years of relevant experience
• Have knowledge of the execution and implementation of the bioanalytics associated with RNA or AAV gene therapy with gene editing preferred
• Experience with independent research, leading projects and managing CROs
• Knowledge of laboratory practices with relevance to GLP/GMP sample handling and analysis with associated documentation
• Experience with supervising laboratory staff and managing direct reports via positive motivation through clear and transparent communication and mentorship
• Demonstrates effective decision-making to steward and prioritize activities to support drug candidate and development programs
• Train and mentor scientists on bioanalytical techniques and scientific methodology
• Produce formal reports for internal use and regulatory filings
• Knowledge of FDA guidance and compliance and ability to oversee assays under prescribed GLP/GMP protocols
• Good oral and written communication skills

We’re committed to finding the best ways to support our teams so they can do their best work. We take care of our employees, right from the start.

Health & Wellness

• Medical, vision, and dental insurance covered at 90%
• Low deductible, no co-insurance and no copays for mental health visits (for in-network care)
• Annual fitness reimbursement
• Employer paid for access to wellness apps and programs like Task Human

Financial

• Competitive compensation
• 401(k) retirement plans with a 4% employer match and no vesting period
• Employer-paid life insurance and short- and long-term disability insurance
• Employer-sponsored flexible spending accounts (FSA) and dependent care account (DCA)
• Access to a 1-on-1 financial advisor
• Commuter reimbursement benefit
• Monthly cell phone stipend

Time Off & Flexibility

• Unlimited paid time off, including vacation, sick leave, family leave, personal days, and bereavement
• 18 paid company holidays, plus an end-of-year holiday shut down
• 12 weeks of parental leave
• Federal Family and Medical Leave Act (FMLA) and Massachusetts Paid Family and Medical Leave (PFML), administered by Unum

Development Journey

• Insights Discovery training for every employee to make the most of workplace relationships
• Ongoing professional development, including manager training
• Access to LinkedIn Learning, a self-guided online education platform