Principal/Senior Scientist, Analytical Science

Principal / Senior Scientist, Analytical Science

Location: Brisbane, CA

Position: Full-Time

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 design, formulation, and 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 Brisbane, CA, to be at the forefront of the future of gene therapy.

Principal/Senior Scientist in Analytical Science

GenEdit is looking for a Principal/Senior Scientist in Analytical Science will be in the department of Global Quality Control Operations and Analytical Sciences. The incumbent will be responsible for leading multiple analytical aspects of a hydrophilic polymer/nanoparticle product throughout its commercial lifecycle.  They will participate on cross-functional teams as the analytical representative on technical and CMC topics.  The person is expected to have significant knowledge of small molecule API or polymer characterization and drug product methods and experience working on commercial regulatory dossiers, health authority responses, as well as analytical CMC strategy.   A strong understanding of GMP is required.

Responsibilities

•Provide analytical subject matter expertise in polymer characterization using various characterization method and overall lifecycle management of commercial release methods and specifications

•Participate on cross-functional teams as the analytical SME

•May lead a matrixed team of commercial analytical scientists

•Collaborate with development teams to ensure analytical commercial readiness of late-phase projects (methods and specifications for the analytical overall control strategy)

•Implement methods for polymer, drug products, process intermediates, and regulatory starting materials at commercial QC testing sites.

•Lead method validations and validation gap assessments to ensure validations are up to current standards, perform method validation remediation, as necessary

•Lead method transfer within in GenEdit or external QC laboratories for the purpose of globalization and lifecycle management (including bringing on new manufacturing sites)

•Write formal analytical documents such as validation protocols/reports, method transfer protocols/reports and investigations reports

•Provide expertise and guidance for problem-solving including method troubleshooting, laboratory investigations, deviations, and CAPA’s,

•Prepare and review analytical CMC sections of commercial regulatory submissions and address analytical-related inquiries from health authorities.

Education and Qualifications:

•Bachelor’s degree in Chemistry or a related field with at least 12 years of experience or Master’s degree in Chemistry or a related field with at least 10 years of experience or PhD in Chemistry or a related field with at least years 8 of experience

•Experience with key analytical techniques: NMR, GPC-RI, HPLC, UV-vis, fluorescence spectroscopy, DSC, ITC,  MAL-SEC, and other characterization methods.

•Experience in the authoring and reviewing technical documents, analytical sections of commercial regulatory files and responding to analytical health authority inquiries

•Strong technology and scientific background in the application of analytical chemistry to small molecule CMC

•Advanced knowledge and understanding of cGMPs

•Experience working in or with QC laboratories

•Knowledge of analytical method development validation and transfer requirements

•Experience with regulatory / analytical CMC requirements

•Demonstrated ability to be SME for analytical trouble-shooting and problem-solving

•Overall awareness of the pharmaceutical manufacturing & quality processes and regulatory requirements necessary to manufacturing and distributing

•Basic understanding of polymer nanoparticle formulation and polymer manufacturing processes

•Excellent written, verbal communication and interpersonal skills with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.

•Work authorization in the US is required

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.