Who are we?

Arbor Biotechnologies™, a next-generation gene editing company based in Cambridge, MA, is advancing a pipeline of novel gene editing therapeutics to address a wide range of genetic conditions – from the ultra-rare to the most common genetic diseases. The company’s unique suite of optimized gene editors goes beyond the limitations of early editing technologies to unlock access to new gene targets and has fueled a robust pipeline of first-in-class assets focused on diseases of high unmet need. With Arbor’s lead program, ABO-101 for the treatment of primary hyperoxaluria type 1, progressing into clinical trials, the company continues to focus their research and development efforts on genomic diseases of the liver and CNS for which there are no existing functional cures. For more information, please visit: 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: 
Are you a quality-driven leader ready to make an impact in a cutting-edge biotech environment? Arbor is seeking an Associate Director of Quality Control to play a critical role in ensuring the highest standards of product quality and compliance. Reporting to the Senior Director of Quality, this is a dynamic opportunity to lead QC activities, collaborate cross-functionally, and influence both internal and external partners.

In this role, you'll oversee release and stability testing, method validation, compliance strategies, and QC operations, all while working at the forefront of gene editing and biotech innovation. If you're passionate about driving quality excellence, optimizing processes, and leading with a collaborative mindset, we’d love to hear from you!

What You Can Expect:

• Responsible for review and approval of all release and stability testing
• Working closely with our external QC test sites, ensure that QC activities are conducted in accordance with the applicable compendial, regulatory and Arbor internal requirements
• Manage and approve all phase-appropriate test method validation activities
• Develop a test method life-cycle program and ensure compliance to the system
• Interface with business partners and external vendors to ensure Quality Control activities are prioritized and completed on time and with a high degree of quality
• Coordinate with the Analytical Development team to ensure analytical procedures are appropriately transferred into QC laboratories in preparation for phase-appropriate validation
• Work collaboratively with technical operations and product development teams to improve quality control test methods, increase efficiency, solve problems, generate cost savings, and provide product support
• Trend all stability data and test method performance related metrics (deviations, batch record review, turn-around-times) and report to management
• Responsible to ensure reference standards are appropriately managed
• Ensure that data integrity principles are understood and implemented consistently in all QC testing
• Lead and manage laboratory investigations, including deviations, OOT/OOS, and environmental excursions and ensure investigations are conducted and documented thoroughly.
• Participate in external audits to ensure compliance with internal procedures, regulations and industry standard, as needed
• Support Health Authority submissions
• Lead setting of appropriate release specifications for starting materials, intermediates, API’s and Drug Product
• Ensure that Quality procedures, practices and analytical methods are in compliance with the applicable compendial, regulatory and customer requirements as well as internal SOP’s

What You Bring: 

• A Bachelor’s or Master’s degree in chemistry, biology or other life science and at least 8 years of experience in Quality Control in a Pharmaceutical/Biotech GMP environment
• Experience in QC and proven ability to have oversight of contract manufacturing and testing organization
• Gene therapy, AAV and/or LNP experience preferred.
• Proven ability to work independently as well as to collaborate and communicate effectively across levels of the organization and work effectively in a team-oriented environment
• Comprehensive knowledge of quality principles and GLP, ICH and GMP regulations
• Excellent attention to detail, project and time management skills, handle multiple priorities with aggressive timelines
• Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making
• Experience managing external QC organizations required
• Experience in method qualification/validation, method transfers and conducting laboratory investigations
• Ability to develop a clear functional strategy, prioritize activities, coach and guide team members and deal with multiple competing priorities a must
• Enthusiastic, proactive, independent as well as collaborative, curious, and results-oriented
• Understanding of regulatory guidance on cell and gene therapy products
• Travel 5% of the time

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

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.