Position Overview:
We are seeking a highly skilled Supply chain manager with extensive experience in a commercial company in a highly regulated industry with global presence, ideally in biotechnology who has experience with outsourced manufacturing components or in full and proven ability to manage multiple CDMOs, vendors and product logistics.
The ideal candidate will be responsible for the entire Fertilo supply chain - from manufacturing currently with a CDMO in the US to delivery to clinics globally. With strong project management acumen, you will ensure that manufacturing processes meet regulatory standards and organizational goals while driving efficiency and innovation. Additional points for familiarity with cell therapy CDMOs and cell therapy products.
Key Responsibilities:
- Solidifying entire Fertilo supply chain and being able to create redundancies and risk plans to prevent supply chain issues.
- CDMO Management: Serve as the primary point of contact for external CDMOs.
- Manage and optimize relationships with CDMOs to ensure high-quality manufacturing processes.
- Oversee contract negotiations, performance monitoring, and compliance with contractual obligations.
- Manufacturing Operations: Develop and maintain comprehensive manufacturing schedules in collaboration with CDMO partners.
- Coordinate production runs, ensuring timely execution and adherence to quality and safety standards.
- Monitor manufacturing performance metrics and implement continuous improvement initiatives.
- Prepare long term manufacturing plans for the company including in house and externally sourced manufacturing.
- Product Release & Logistics Coordination:
- Work closely with quality assurance teams to coordinate product release processes.
- Ensure effective logistics and distribution planning to meet delivery timelines.
- Oversee documentation and regulatory submissions related to product release and transportation.
- Finance & Budget Collaboration: Collaborate with finance teams to develop and manage budgets related to manufacturing contracts.
- Track project costs and provide regular financial updates, ensuring adherence to budgetary constraints.
- Analyze financial performance metrics and support cost-saving initiatives.
- Quality & Deviation Management: Partner with quality teams to address and resolve manufacturing deviations and non-conformities.
- Lead root cause analyses and implement corrective actions to prevent recurrence.
- Ensure compliance with regulatory requirements and internal quality standards.
- Project Management: Lead cross-functional project teams to ensure seamless integration of manufacturing processes.
- Develop and maintain detailed project plans, timelines, and risk mitigation strategies.
- Communicate project status, challenges, and successes to internal stakeholders and executive leadership.
- Stakeholder Engagement: Facilitate effective communication between internal departments (e.g., R&D, Quality, Finance) and external partners.
- Prepare and present regular updates on manufacturing performance, contract status, and project progress.
- Foster a culture of collaboration and continuous improvement within the manufacturing team.
- Shipment to customers, clinical trial sites - US and globally: Fertilo is shipped in ice/cold storage. Work with vendors and identify best and cost effective shipping methods, couriers, logistics and storage facilities to create
- Manage and create supply chains for commercial jurisdictions working with local team members and advisors
- Follow and stay up to date with all local and international regulatory requirements to ensure compliance and smooth company operations.
Qualifications:
- Education: Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or a related field. Advanced degree preferred.
- Experience:
- 5+ years of experience in supply chain & manufacturing CMDO management in a commercial stage biotechnology company
- Proven track record of managing relationships with CDMOs and coordinating complex manufacturing operations.
- Financial Acumen: Experience working with finance teams on budgeting, cost tracking, and financial reporting.
- Problem-Solving: Strong analytical skills with the ability to manage deviations and implement corrective actions.
- Communication: Excellent interpersonal and communication skills, with the ability to liaise effectively with cross-functional teams and external partners.
- Leadership: Ability to lead cross-functional teams and manage multiple projects simultaneously.
- Attention to Detail: High level of accuracy and attention to detail in scheduling, documentation, and compliance.
- Adaptability: Flexibility to work in a fast-paced, dynamic environment while managing competing priorities.
- Innovative Thinking: Proactive in identifying process improvements and driving operational efficiencies.
- Results-Driven: Focused on achieving strategic objectives and delivering high-quality manufacturing outputs.
- Location: Located in Austin, TX or New York, NY.
How to Apply:
Interested candidates should submit their resume and a cover letter outlining their relevant experience and qualifications via Linkedin. Please include title in the subject line.
Join our team and contribute to the advancement of cutting-edge cell therapy products by ensuring the highest standards of manufacturing excellence. We look forward to reviewing your application!
Company Summary:
Gameto is a clinical & commercial stage biotechnology company developing novel treatment solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of one of North America's largest fertility networks Prelude Fertility, Martin Varsavsky, as Chairman. For more information, visit gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.
Gameto has raised $73M to date from investors including Two Sigma Ventures, RA Capital, Insight Partners, Future Ventures, Bold Capital, Lux Capital, Bob Nelsen of Arch Ventures, and Anne Wojcicki of 23andMe, and $10 million to accelerate the company’s menopause program. We are an equal-opportunity employer. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
