Who are we?

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.

Who are you?

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!

About The Role:

We are seeking a highly skilled and experienced Director, CMC Lead & 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 Arbor’s drug products and materials critical to enabling Arbor’s clinical pipeline. The ideal candidate will have extensive experience in project management, process development and/or MSAT, manufacturing, and process validation, as well as project and vendor management, authoring regulatory filings, and a strong understanding of cGMP compliance with the business acumen to interface with multiple key external partners.

What You Can Expect:

• Manage CMC project plans and represent CMC as a core program team member, ensuring alignment across internal and external stakeholders.
• Lead multiple external manufacturing projects, meeting timelines, budgets, and quality standards.
• Develop and maintain project plans, risk assessments, and mitigation strategies.
• Build and manage a strategic vendor network; develop RFPs, evaluate CDMOs, and maintain strong vendor relationships.
• Negotiate vendor contracts to ensure cost-effectiveness, compliance, and alignment with best practices.
• Ensure external manufacturing activities comply with cGMP and company quality standards; partner with Quality to conduct audits and drive improvements.
• Oversee external process development and optimization for viral vectors, LNPs, nucleic acids, and other key supply chain components; troubleshoot issues and align internal/external teams.
• Review regulatory submissions, production records, and quality investigations; provide technical oversight to ensure scalable, compliant manufacturing processes.
• Drive continuous improvement initiatives to reduce costs, improve quality, and strengthen validation strategies.
• Promote a culture of innovation, collaboration, and operational excellence across internal teams and external partners.

What You Bring: 

• 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

Our Values: 

Our values govern the work we do at Arbor, and we’re hoping that they resonate as strongly with you as they do with us!

· Purposeful Action: Start with The Why

· Bold Resilience: Adopt a Growth Mindset

· Humble Authenticity: Start in the Heart

The anticipated salary range for candidates for this role will be $208,000 - $225,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, industry knowledge, technical skills, and other factors that may prove relevant during the interview process.

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.