- 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
Why join Life Edit and the ElevateBio ecosystem?Life Edit Therapeutics is an integrated subsidiary of ElevateBio, a technology-driven cell and gene therapy company that is accelerating access to the cutting-edge technologies and expertise that can change the future of medicine. Our integrated model combines multiple R&D technology platforms – including Life Edit gene editing – and cGMP manufacturing to power the discovery and development of advanced therapeutics. Our ecosystem is designed to enhance speed, delivery, and probability of success to change patient lives.
Life Edit is an integral part of ElevateBio's ecosystem of platform technologies and is pioneering focused next-generation gene editing technologies and therapeutics. Located in Durham, NC, members of Life Edit work closely with the ElevateBio Research and Development and BaseCamp manufacturing teams in Waltham, MA. Life Edit is advancing therapeutic programs in collaboration with industry partners while building its own internal pipeline of gene editing therapies. We are looking for a unique individual who can continue to lead the cultural development of Life Edit and build on its momentum as an integral part of the ElevateBio ecosystem.
Our Mission:
To power the creation of life-transforming cell and gene therapies, at a speed the world deserves.Our Vision:
We seek to be the world's most indispensable cell and gene therapy technology company, redefining how companies operate, how products are created and how disease is treated.ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
-
Manager, Regulatory Affairs, Formulations,
1 week ago
Stryker Corporation Cary, United States**Why RA/QA at Stryker?**: · **Who we want** · - ** Managers who drive performance. **People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity. · - ** Network builders. **Managers who build connections w ...
-
Research Technician II
1 week ago
Duke University Durham, United StatesSchool of Medicine · Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clini ...
-
Medical Technologist
1 week ago
Charles River Laboratories Durham, United StatesMedical Technologist · Req ID #: 221812 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impac ...
-
Medical Technologist
1 week ago
Charles River Laboratories Durham, United StatesMedical Technologist · Req ID #: 221812 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impac ...
-
Immunopathology Technician III
5 days ago
Charles River Laboratories Durham, United StatesImmunopathology Technician III · Req ID #: 222611 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a signifi ...
-
Immunopathology Technician III
5 days ago
Charles River Laboratories Durham, United StatesImmunopathology Technician III · Req ID #: 222611 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a signifi ...
-
General Manager
3 days ago
Charles River Laboratories Durham, United StatesGeneral Manager · Req ID #: 222651 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on ...
-
Necropsy-Team Lead
1 week ago
Charles River Laboratories Durham, United StatesWe are seeking a Team Leader - Necropsy for our Discovery site located Durham. · Provide technical leadership on all daily activities in the areas of scheduling, gross pathology findings, supervision, study assignment setup and database management. Perform complex necropsy functi ...
-
Immunopathology Technician I
5 days ago
Charles River Laboratories Durham, United StatesImmunopathology Technician I · Req ID #: 222747 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significa ...
-
Immunopathology Technician II
4 days ago
Charles River Laboratories Durham, United StatesImmunopathology Technician II · Req ID #: 222749 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a signific ...
-
Immunopathology Technician I
4 days ago
Charles River Laboratories Durham, United StatesImmunopathology Technician I · Req ID #: 222747 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significa ...
-
Immunopathology Technician II
4 days ago
Charles River Laboratories Durham, United StatesImmunopathology Technician II · Req ID #: 222749 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a signific ...
-
Director, In Vivo Operations
1 week ago
Charles River Laboratories Durham, United StatesDirector, In Vivo Operations · Req ID #: 220808 · Location: · Durham, NC, US, 27709 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significa ...
-
Director, In Vivo Operations
4 days ago
Charles River Laboratories Durham, United StatesDirector, In Vivo Operations · Req ID #: 220808 · Location: · Durham, NC, US, 27709 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significa ...
-
Duke seeks Vascular Neurologist
1 day ago
Duke Health Durham, United States Full timeThe Department of Neurology at Duke University School of Medicine is seeking an additional Vascular Neurologist to join its expanding Stroke and Vascular Neurology Division, which currently has seven primary faculty, nine secondary faculty and seven nurse practitioners. Individua ...
-
Human Resources Business Partner
6 days ago
Charles River Laboratories Durham, United StatesHuman Resources Business Partner · Req ID #: · Location: · Durham, NC, US, 27709 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a signific ...
-
Duke Health Durham, United StatesSeeking a Clinical Psychologist with expertise in the assessment and treatment of children and adolescents with autism spectrum disorder (ASD). Clinical responsibilities will include: · participating in an interdisciplinary, team-based treatment program at the Duke Center for Aut ...
-
Senior Human Resources Business Partner
6 days ago
Charles River Laboratories Durham, United StatesSenior Human Resources Business Partner · Req ID #: · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a s ...
-
Senior Human Resources Business Partner
1 week ago
Charles River Laboratories Durham, United StatesSenior Human Resources Business Partner · Req ID #: 222638 · Location: · Durham, NC, US, 27703 · For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have ...
-
Duke Health Durham, United States Full timeThe Department of Psychiatry and Behavioral Sciences at Duke University School of Medicine is looking to expand its brain stimulation program. We are seeking a clinical/translational investigator who can lead an interdisciplinary research program integrating preclinical insights ...
Senior Scientist, Bioanalytical Development, Preclinical Development - Durham, United States - Life Edit Therapeutics
Description
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:
