Director/Senior Director, Analytical Operations
About The Job We are seeking an exceptional leader to develop and implement innovative analytical technologies and testing strategies from preclinical and IND-enabling studies through clinical development and commercialization.
Who We Are We are an early-stage biotechnology company pioneering a new class of medicines for individuals, especially children, living with genetically driven diseases. Powered by a non-viral DNA vector system, our mission is to develop novel therapeutics that bypass the current limitations of gene therapy and achieve higher standards for potency, durability, redosability, and safety. Funded by leading investors and led by seasoned experts in gene delivery, protein sciences, and clinical translation.
The Impact You Will Make This leader will be responsible for driving analytical technology innovation and development strategies for non-viral DNA-based gene therapy drug products, along with fostering a culture of inclusion, empowerment, scientific excellence, collaboration, and engagement. You will create a comprehensive roadmap for product analytics, contribute to long-term technology and operational strategies, drive rapid implementation of new technologies, and ensure functional excellence for regulatory strategies and operational efficiencies leveraging automation and state-of-the-art data management. This is a leadership position with critical accountabilities and influence on the pipeline product portfolio from pre-candidate nomination through research, development, commercialization, and beyond. The position requires strong technical partnership and collaboration with multiple stakeholders including Early Research, Gene Delivery Technology, CMC and Process Development, and Quality. This role is based in Southern California.
What You'll Bring
Technical
- Demonstrate technical leadership while collaborating closely with leaders from other functional areas and potential external partners.
- Serve as a thought leader for analytical technology innovation, integrated process and analytical control strategies, and integrated technical development and regulatory strategies for DNA-based vectors and non-viral DNA delivery technologies.
- Create a comprehensive roadmap for drug product and DNA vector analytics, as well as critical raw materials, process, and product residuals.
- Drive rapid implementation of new analytical technologies into CMC and clinical programs, ensure functional excellence for regulatory strategies for INDs and BLAs, and ensure operational efficiencies leveraging automation as well as state-of-the-art data analysis and management.
- Provide key strategic compliance and analytical development input to projects and cross-functional teams, including early research, and process development and manufacturing.
- Ensure scientific integrity and quality of regulatory submissions and support interactions with the global health authorities.
- Contribute Program Development Strategy including risk identification and mitigation plans, program development activities, timelines, and resource allocation.
Leadership
- Build and strengthen a cohesive and motivated department that understands its issues, challenges, and opportunities.
- Engage and retain talent by understanding individuals' development needs and aligning with business requirements.
- As part of the R&D Leadership Team, drive technical vision, strategy, and programs to meet corporate objectives.
- As part of the R&D Leadership Team, help define and effectively communicate a compelling scientific vision internally and externally.
- As part of the R&D Leadership Team, contribute to gene therapy insights and technology through publications and external partnerships to deliver best-in-class therapies to patients.
Education and Experience Required
- MS/Ph.D. degree in Immunology, Life Sciences, Chemistry, Pharmacology, or Engineering or similar.
- 5 years (>10 years for Senior Director) of experience in the development of gene therapy products or biologics.
- Knowledge and direct experience in developing analytical technology and methods, characterization and release of gene therapy drug products, including lipid nanoparticle (LNP) and/or polymer nanoparticle (PNP) formulation, is strongly desired.
- Experience with regulatory filings of rare disease products is preferred.
- Demonstrated excellence in developing, mentoring, and managing staff.
- Proven leadership and ability to positively influence colleagues and key decision-makers.
- Demonstrated collaboration skills working cross-functionally, maintaining strong stakeholder relationships, influencing direction, voicing opinion, and communicating.
Benefits & Additional Information
- Compensation range: $145,000-$230,000 annually plus additional bonus, benefits and relocation support
If you are interested please apply to be considered.
