Head Of Technical Development

Who are we looking for?

We are seeking an experienced and highly motivated leader to join our dynamic team, responsible for overseeing all aspects of the chemistry, manufacturing, and controls-related activities, as well as managing clinical supply chain and manufacturing, for our RNA exon editing programs, ensuring the highest standards of quality, safety, and efficacy. This is a critical position, focused on innovative process, analytical, and technology development, that tightly collaborates with our internal teams and external partners, focused on early development &translational R&D, cGMP clinical supply, regulatory filings, quality, and the ultimate approval of medicines that will dramatically improve patient’s lives.

Your contribution to Ascidian:

• Develops and oversees the implementation of comprehensive CMC strategies for our RNA exon editing programs, ranging from candidate nomination, first-in-human, and pivotal clinical studies to BLA with intended commercial process & analytics and appropriate control strategies.
• Provides strategic and technical oversight of third parties, including negotiating and managing relationships with contract development and manufacturing organizations (CDMOs and drug depot vendors), and other external partners to ensure the timely delivery of high-quality materials for preclinical and clinical studies.
• Develops and manages budgets, timelines, and resources for CMC and clinical supply chain activities, ensuring projects are completed on time and within budget.
• Leads and manages all CMC regulatory interactions and responses, both in and outside of the US.
• Authors and critically reviews relevant documents including but not limited to all CMC regulatory submissions, briefing booklets, information requests, etc.
• Ensures compliance with all relevant regulatory guidelines and quality requirements.
• Maintains up-to-date knowledge of the latest advancements in gene therapy and editing technologies and regulatory landscape, and apply this knowledge to inform and guide CMC strategies.
• Oversees relevant internal IND enabling activities, including analytical development, tech
  transfer to cGMP compliance externally.
• Develops processes and analytics to support decisions and development timelines for our RNA exon editing programs.
• Develops and manages the AAV capsid strategy, developing and maintaining academic collaborations, as well as identifying both internal and external opportunities to continue to innovate and develop competitive advantages.
• Evaluates and implements novel technologies and processes to enhance product quality, manufacturing efficiency, and cost-effectiveness.
• Lead CMC-related SOP development

What you need to succeed:

• PhD in Molecular Biology, Biochemistry, Biotechnology, or a related pharmaceutical science field.
• 8+ years relevant biopharmaceutical experience, with a focus on CMC and gene therapy product development. Direct experience with AAV gene therapy IND submission is strongly preferred.
• Broad understanding of gene therapy and editing vector and drug product process and analytical development and a proven track record in CMC development for clinical stage programs.
• Specifically experienced in adeno-associated virus (AAV)-based vectors, their design, production, quality, composition, and analytics.
• A deep understanding of the cGMP manufacturing and regulatory requirements for gene therapy and editing products.
• Entrepreneurial and passionate about innovative science and drug development, with strong resilience, agility and ability to manage ambiguity and make decisions with limited information and resources
• A strong team player, present with the rest of the team contributing to the highly collaborative and fun culture, with ability to travel to visit external partners.
• Excellent verbal and written communication skills and the ability to effectively work across levels, functions, and with both internal and external stakeholders.
• Strong analytical and problem-solving skills, with a keen attention to detail and a commitment to quality.