Sr. Director, Manufacturing Operations & Supply Chain
Hybrid
CMC /
Salaried, full-time /
Hybrid
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!
What you can expect:
As a member of the CMC Team reporting to the VP, Head of CMC, the Sr. Director Manufacturing Operations and Supply Chain will ensure successful execution of the Arbor’s manufacturing strategy with a focus on the manufacturing and vendor management to support our gene editing therapeutics portfolio, including LNP and AAV deliveries. The incumbent will oversee external manufacturing activities for CMC product development programs at CDMOs, CMOs and CTOs to meet clinical supply and global compliance requirements as well as ensuring successful supply chain activities. Given the external nature of Arbor’s manufacturing network there will be a major focus on ensuring partnerships are established and maintained with suppliers that meet Arbor’s strategic goals, balance cost and risk, without compromise to quality or compliance. This is a cross-functional and highly visible role within Arbor, requiring strategic interactions between internal and external stakeholders.
- The Sr. Director, Manufacturing Operations will proactively plan, manage, and track all manufacturing related activities; anticipate, resolve, and escalate issues and successfully coordinate manufacturing plans with forecasted clinical development plans.
- Provide scientific and technical leadership, manage relationships with CDMOs, CTOs and key suppliers including coordination, communication, and technical oversight, to ensure timely delivery of cGMP products to support clinical trials.
- Responsible for short and long-term planning and budgeting for the CMC Company's activities, including the development of phase-appropriate manufacturing processes for drug substances and formulated drug products.
- The incumbent will be the point of contact with all CMC vendors to drive completion of vendor and business cGMP activities and agreements, including MSA, SOWs, manufacturing agreements and schedules, testing, deviation investigation, batch review and coordination of GMP material supply.
- Collaborate with Project Management and CDMOs in developing project plans and schedules and ensure that tasks are executed according to the operational plans, Master Services and Quality Agreement, cGMP requirements and regulatory commitments.
- Work with cross-functional teams across the organization including Process & Analytical development, R&D, Program Management, Business Development, Legal, Clinical Operations, Clinical Sciences, Regulatory, Commercial, People Team, Site Operations, and others.
- Working closely with the company’s Quality Assurance function, ensure all CMC activities are consistent with industry practices and appropriate international development and commercial standards, including current Good Manufacturing Practices (cGMP) and the International Conference on Harmonization (ICH), and in alignment with the company’s Quality Management System
- Provide input into new product strategies and seek to enhance the company's proprietary positioning of products, including new intellectual properties.
- Ensure effective clinical supplies logistics (pack, label, distribution)
- Partner with finance colleagues to actively manage budgets and costs relating to CMC.
- Identify critical items and mitigation plans for communication to Arbor’s Leadership
- Review and approve all manufacturing related GMP documents.
- Participate in preparation and review of CMC sections of regulatory filings (IND/CTA and BLA)
- Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness.
- Identify and coordinate additional development activities and manufacturing through various phases of product development.
- Arrange and oversee shipments of drug substance and drug product and associated samples to 3rd party warehouses, CTOs and CROs for testing, and clinical sites distribution.
What you bring:
- BS, MS or PhD in relevant science or engineering discipline
- Experience with RNA, LNP and AAV manufacturing is a plus.
- Extensive experience leading Supply Management for clinical and commercial products
- At least 12 years of experience in the biopharmaceutical industry
- Prior leadership position(s) in manufacturing operations management, including responsibility for delivering DS and DP for investigational clinical trials and commercial supply.
- Direct, hands-on, experience leading early and late phase product development and GMP activities internally and at CDMOs.
- Results-oriented, scientifically rigorous, and relentless commitment to quality
- Familiarity with line management and project management, embracing budgets and timelines.
- Excellent collaborative, analytical, communication, managerial and supervisory skills
- Capable of building trust and influencing across all levels of the organization
- Advanced knowledge of GxP and global regulatory guidance in Cell and Gene Therapy modalities.
- Solid record of accomplishments in building relationships with internal stakeholders, external manufacturing partners and managing external manufacturing networks.
- Track record of strategic, big picture, thinking, problem-solving, decision-making, developing and implementing realistic action plans to achieve specific goals.
- Excellent communication skills
- Ability and willingness to travel up to 25- 30%, including domestic and international travel.
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.
