Overview:

Germfree Laboratories is currently seeking a Director of Strategic Development to take a pivotal part in crafting innovative strategies for decentralized manufacturing of advanced therapies within our organization. We are in search of a visionary leader who can adeptly merge Germfree's product and services portfolio, digital strategies, core partnerships, and technology to elevate global access to vital therapies for patients worldwide.

Key Responsibilities

• Collaborate closely with the Chief Strategy Officer to define and implement a robust digital framework that supports a decentralized, hub and spoke manufacturing model.
• Lead the strategic evaluation and development of the business model for commercializing cell and gene therapies post-regulatory approval, leveraging expertise in technology-driven market transformations and high-growth environments.
• Design and oversee the implementation of scalable manufacturing processes tailored for decentralized settings, particularly in cell therapies and viral vectors.
• Establish and maintain GMP-compliant facilities internationally, enhancing supply chain resilience and production efficiency.
• Forge and nurture strategic partnerships with a diverse array of stakeholders including apheresis centers, CROs, CDMOs, academic institutions, equipment providers, and regulatory bodies, with a strong acumen in building collaborations.
• Coordinate with international regulatory agencies to ensure compliance and facilitate the global scalability of the manufacturing model.
• Drive business development activities by leveraging existing customer engagements and identifying new opportunities within the decentralized manufacturing space.
• Spearhead innovation in core technologies identified as critical to the decentralized manufacturing model, ensuring Germfree stays at the forefront of technological advancements.

Qualifications:

• A minimum of 15 years of experience in strategic roles within the pharmaceutical or biotechnology industry, with significant expertise in cell and gene therapy operations and process development.
• Demonstrated leadership in managing technology-driven transformations and strategic planning in high-growth environments.
• Profound knowledge and practical experience with digital systems such as Electronic Data Capture (EDC), Electronic Medical Records (EMR), Manufacturing Execution Systems (MES), and/or Quality Management Systems (QMS).
• Proven track record of developing technologies and services solutions that enhance production efficiency.
• Experience in navigating regulatory and market access challenges, proficient in organizational change management.
• Understanding of regulatory environments and experience engaging with international health authorities.
• Exceptional leadership skills with a track record of building and maintaining high-performing teams and partnerships.
• Exposure to the complexities of delivering cell therapy products through the healthcare system. Payer expertise a plus.
• Experience working in service environments like CDMOs, CROs a plus.
• Advanced degree preferred in Business, Biology, or a related field, with substantial knowledge of cell and gene therapy markets.

Skills:

• Strategic thinking with a clear ability to design and implement complex business models.
• Strong analytical and problem-solving skills, capable of navigating high-stakes decisions.
• Excellent communication and interpersonal skills, adept at engaging with diverse international stakeholders.
• High level of integrity and dependability with a strong sense of urgency and results-orientation.
• Start-up company experience is highly regarded.