Sr. Scientist/Group Leader, Analytical Assays
South San Francisco, CA /
Analytical Assays /
GenEdit is a rapidly-growing, early-stage company that is developing a proprietary and novel delivery platform with the potential to transform genetic medicine. Our interdisciplinary team works together across chemistry, payload, formulation, screening, and preclinical groups to develop the next generation of gene therapies. GenEdit fosters an exciting and dynamic environment where we value impactful data and creative solutions to accelerate our progression from a platform technology to a pipeline of therapeutic candidates. We are seeking talented and motivated individuals to join our team and are expanding across all functions within the organization. Join us in South San Francisco, CA, to be at the forefront of the future of gene therapy.
We are seeking a talented and motivated individual to our join our organization to lead the Analyical Assays Team. This position reports to the Chief Technology Officer and will be responsible for the development of analytical assays to characterize chemical polymers and polymeric nanoparticles for future therapeutic applications. The ideal candidate will have experience in understanding the selection, development, and qualification/validation of analytic assays to determine the critical quality attributes (CQA) of drug product candidates and its key components. He/she will be familiar with analytical methods to characterize complex chemical and organic molecules and nanoparticles.
This position will also participate in the development and preparation of certificates of analysis, transfer of analytical methods to CMOs, and managing external analytical testing labs as needed. He/she will be an independent and critical thinking scientist with attention to detail to develop and optimize assays for consistent and reproducible results. This position will work in collaboration with the Chemistry, Formulation, In Vitro Cell Biology, and In Vivo Studies teams to identify and select candidate polymer nanoparticles for further therapeutic development.
- Project Leadership: The Sr. Scientist/Group Leader will develop, gain approval, and execute the workplan to complete the milestones and goals of the project(s) outlined in the overall company and program goals. Specifically, he/she will develop and execute the strategy for the comprehensive analytical assay panel, key CQAs, and data to support the characaterization of the key components the polymer nanoparticle and final drug product. He/she will be a member of the R&D management team and participate in the scientific and technical discussions and decisions on the data to support the identity, purity, and potency of the key components of the drug product(s) and drug product(s).
- Communication: The Sr. Scientist/Group Leader will represent the Analytical Team internally and be responsible for communicating project progress to R&D management and executive leadership. He/she will address project issues and propose solutions. The Sr. Scientist/Group Leader will actively participate in internal scientific discussions and meetings and will represent GenEdit at alliance and joint steering committee meetings with external collaborators and partners.
- Innovation: The Sr. Scientist/Group Leader will participate in new target identification, R&D project goal prioritization, internal strategic discussions and decisions, and will provide expert scientific guidance, as needed.
Education and Qualifications:
- Ph.D, or equivalent in a relevant life science field
- At least 5 years of scientific/pharma research and development experience with analytical assays for characterizing chemically synthesized organic polymers, bioactive molecules, and/or polymeric nanoparticles.
- Broad knowledge and deep experience with a variety of analytical assay methods from conceptualization and development through to qualification and validation.
- Familiarity with HPLC Size Exclusion Chromatography (SEC) and/or other polymer fractionation techniques (FFF, LAC, etc.), LC/MS, NMR and/or thermal characterization techniques such as TGA and DSC a definite plus.
- Familiarity with nanoparticle characterization and cell-based assays a plus.
- QA/QC experience is a plus.
- Experience in gene therapy and/or genetic medicines is a plus
- Work authorization in the US is required
Skills and abilities
- Intellectually agile and able to thrive in a fast-paced, innovative environment
- Experience with leading and motivating direct report(s) and working collaboratively with internal collaborators and peers.
- Excellent oral and written communication skills
- Creative and pro-active approach to problem-solving
- High level analytical capability
- Personable, sociable, and eager to help build Genedit’s culture and future
- Willingness to “roll-up the sleeves” and work as part of a team on all aspects of the project.
- Open-minded, flexible, and cooperative in a dynamic and fast-growing company
- Highly professional, motivated, energetic, and “can-do”, problem-solving attitude
At GenEdit we are always looking to hire the absolute best talent and recognize that diversity in our experiences and backgrounds is what makes us stronger. We hire candidates of any race, color, ancestry, religion, sex, national origin, sexual orientation, gender identity, age, marital or family status, disability, veteran status, and any other status. These differences are what enable us to work towards the future we envision for ourselves, and the world.