We are a next-generation gene editing company focused on discovering and developing potentially curative genomic medicines, with the most extensive toolbox of proprietary genomic editors in the industry. We have the unique ability to work backward from disease pathology and choose the optimal editors or combination of editors for the disease in question. Find out more at Arbor.bio.

Passionate, determined, and accountable. Curious, resourceful, innovative, forward thinking, and resilient. Authentic, humble, open-minded and puts team above self. At Arbor, our people embrace these qualities, so if this sounds like you then please read on!

We are seeking a highly skilled and experienced Director of CMC Operations to manage the operationalization of Arbor’s technology platform into drug product by coordinating the integration of internal and external development teams, drive tech transfer processes, and oversee the GMP manufacture, release, stability, storage, and distribution of viral vectors, lipid nanoparticles, nucleic acids, and other materials critical to enabling Arbor’s clinical pipeline. The ideal candidate will have extensive experience in process development, manufacturing, and validation, as well as project and vendor management, authoring of regulatory filings, and a strong understanding of cGMP compliance with the business acumen to interface with multiple key external partners.

· Lead and manage multiple external manufacturing projects, ensuring timelines, budgets, and quality standards are met.

· Develop and maintain detailed project plans, risk assessments, and mitigation strategies.

· Coordinate with internal and external stakeholders to ensure alignment and successful project execution, and present CMC activities and timelines to the program team.

· Establish strategic vendor ecosystem in alignment with Arbor’s long-range planning, develop appropriate RFPs, evaluate candidate CDMOs, establish and maintain strong relationships with vendors to ensure seamless and efficient manufacturing processes.

· Negotiate contracts, terms, and agreements with vendors to ensure best practices, cost-effectiveness, and compliance with regulatory standards.

· Ensure all external manufacturing activities comply with cGMP regulations and company quality standards. In collaboration with Arbor’s Quality unit, conduct regular audits and assessments of external vendor facilities to ensure compliance and identify areas for improvement.

· Oversee the external development and optimization of manufacturing processes for key components of Arbor’s supply chain including, but not limited to, viral vectors, lipid nanoparticles, and nucleic acids, troubleshoot and resolve technical issues that arise during external manufacturing processes, and ensure harmonization between internal and external development teams.

· Manage and review documentation related to regulatory submissions, production records, and quality investigations, providing technical oversight and support to external vendors to ensure robust and scalable manufacturing processes.

· Drive continuous improvement initiatives to enhance manufacturing processes, reduce costs, improve product quality, and provide strong influence and oversight into process performance qualifications and overall validation strategies.

· Foster a culture of innovation and collaboration within the manufacturing team and with external vendors.

· Advanced degree (MS, PhD, or equivalent) in Chemistry, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, or related field.

· Minimum of 10 years of experience in CMC development and manufacturing within the biopharmaceutical industry.

· Proven track record of successfully managing CMC activities and external manufacturing relationships.

· In-depth knowledge of regulatory requirements and industry standards related to CMC and GMP manufacturing.

· Strong leadership, project management, and negotiation skills.

· Ability to travel domestically and internationally.

· Experience with Six Sigma, Lean manufacturing, Value Stream mapping experience a plus

· Experience working in a startup that grew rapidly a plus

· Positive attitude and good judgment, a person people seek out for advice

· Excellent communication skills – oral, written, listening, inclusive of others’ ideas

· Trustworthiness, personal integrity; able to maintain a high degree of confidentiality

· Effective time management and organizational skills

· Personal accountability, learning agility, collaboration, personal touch and stewardship

· Purposeful Action: Start with The Why

· Bold Resilience: Adopt a Growth Mindset

· Humble Authenticity: Start in the Heart

We promote diversity and inclusion not just in our recruitment processes, but in everything we do. We’re an equal opportunity employer and we will continue to ensure our recruitment process is free of bias and our workplace is inclusive, positive, and free of discrimination and respecting of all backgrounds and beliefs.