Director, Analytical Development

We are a fully integrated AAV engineering and gene therapy company poised to create the next generation of innovative genetic therapies, with life-changing potential for patients with grievous unmet medical needs.

We leverage our proprietary high-throughput AAV engineering platform to create viral vectors with cell-type and tissue level specificity, overcoming many of the biological limitations of early gene therapy efforts. Combined with our in-house preclinical and manufacturing expertise, we are positioned to create the next generation of AAV delivered gene therapies, dramatically changing the lives of patients.

We are founded on the idea that diverse backgrounds and skill sets combine to create an environment that stimulates innovation and creativity, enabling us to grow into a leader in the AAV gene therapy space. Our leadership team is comprised of the scientific founders that developed the underlying intellectual property, and experienced industry veterans with a track record for bringing transformative drugs to market. Together with our partners, we will combine next generation engineered capsids with innovative gene editing and delivery modalities to bring novel medicines to patients that need them. Our research and development labs, offices, and manufacturing space are located in Thousand Oaks, California, near the Amgen campus.

Director, Analytical Development

We are looking for a highly talented and motivated Director of Analytical Development to lead Capsida’s analytical and formulation development group that supports our portfolio of engineered AAV gene therapies. The successful candidate will be responsible for internal analytical development, formulation development and GMP testing, and will coordinate method development, qualification, and validation. The individual will have an in-depth knowledge of AAV gene therapy analytical methods that include HPLC/UPLC, AUC, SEC, AF4, HIAC/MFI, LC-MS, NGS, DLS CE-SDS, ddPCR/qPCR, ELISAs, High Content Analysis, cell-based potency/infectivity assays. The candidate will work closely with Research and Technology, Process Development, and QA functions to ensure scientific and information transfer occurs in a highly collaborative environment.

Responsibilities

• Provide experienced leadership for mentoring staff developing effective teams with high scientific standards.
• Direct methods development, transfer, and phase-appropriate validation for release & stability testing, in-process analysis and starting materials and intermediate testing.
• Design and oversight of formulation development, robustness, clinical in-use compatibility, and other related studies.
• Develop systems to manage stability programs in compliance with ICH guidelines.
• Departmental budgeting and resource management.
• Provide testing support for internal process development and vector production.
• Facilitate coordination of analytical activities with research and technology, process development, manufacturing, quality, regulatory, and clinical supply.
• Author and/or review appropriate development reports and related sections of Regulatory filings, such as INDs, IMPDS, CTAs, BLAs, etc.
• Contribute to continuous improvement of quality systems.
• Expert knowledge and application of internal and external regulatory (ICH, FDA, EMA, GLP etc.) and GMP requirements.

Essential Qualifications

• PhD in bioanalytical chemistry or relevant field with a minimum of 8 years industry experience in analytical development for gene therapy, or MS with a minimum of 12 years of relevant industry experience. Strong preference for experience in CMC related to AAV gene therapy and managing outsourced analytical activities.
• Demonstrated scientific proficiency in the analysis of viral vectors and other biologics. Analytical techniques include peptide mapping, HPLC/UPLC, AUC, SEC, AF4, HIAC/MFI, LC-MS, NGS, DLS CE-SDS, ddPCR, ELISAs, High Content Analysis, cell-based potency/infectivity assays, and compendial methods.
• Extensive experience with assay development, with solid knowledge of cGMP practices.
• Proven track record of effectively leading cross functional teams. Ability to effectively manage multiple responsibilities, tasks, and projects in a dynamic, fast-paced environment.
• Direct experience interacting with regulatory authorities and preparing and reviewing CMC documentation for regulatory filings.
• Proven leadership experience mentoring staff and developing effective teams with high scientific standards.
• Excellent oral and written communication skills.

Compensation and Benefits:

The well-being of our employees and their families is of the highest importance. As such, we offer a competitive salary and exceptional benefits, including generous stock options, medical, dental, vision, disability, life insurance, and significant PTO.

Director Salary: $168,000 - $231,000 per year

Compensation will vary depending on location, job-related knowledge, skills, and experience. You may also be offered a bonus, stock options, and benefits. These ranges are subject to change.

Additionally, we offer:

• Relocation compensation
• Fully stocked kitchen
• Social lunches, happy hours, and other events on a regular basis

We are an equal opportunity employer. All applicants will be considered for employment without attention to age, race, color, religion, sexual orientation, gender identity, national origin, veteran or disability status, or any classification protected by federal, state, or local laws.