Pave Talent hiring on behalf of our client – a dynamic cell therapy startup in South San Francisco, CA. We are looking for an exceptional Director of Technical Operations (Cell Therapy Start Up - CMC & MSAT) to join our client’s innovative team. This role offers the chance to lead and shape the future of cell therapy manufacturing.
About the Client: Our client is a rapidly growing cell therapy startup revolutionizing the biotech industry. The company is committed to advancing cell therapy treatments with a state-of-the-art multi-product manufacturing facility. The team is passionate about pushing the boundaries of science to deliver life-changing therapies to patients worldwide.
Key Responsibilities:
- Leadership & Development: Lead, coach, and develop a team of experts supporting clinical production within the facility. Serve as the process and analytical Subject Matter Expert (SME) for internal and external collaborators.
- Technical Leadership: Oversee the design, construction, commissioning, qualification, validation, and operation of the manufacturing facility, driving it towards Good Manufacturing Practice (GMP) readiness.
- Regulatory Compliance: Develop and implement Chemistry Manufacturing and Controls (CMC) regulatory filing strategies, ensuring compliance with global health authority requirements.
- Project Management: Own and drive continuous improvement projects, manage departmental metrics, and handle Quality events including change controls, investigations, and CAPAs.
- Stakeholder Engagement: Build and maintain strong relationships with internal and external stakeholders to successfully execute the strategic plan for the manufacturing site.
Qualifications:
- Educational Background: Bachelor’s degree in science, engineering, or a related field.
- Industry Experience: 8+ years in a cGMP environment within the biotechnology/biopharmaceutical industry, with a focus on MS&T, Technical Operations, or Technical Development.
- Leadership Experience: 6+ years of leadership experience, preferably in Cell/Gene Therapy and CDMO settings.
- Technical Expertise: In-depth knowledge of cell therapy regulations, facility/clean room design, process equipment automation, and validation. Experience with start-up validation and licensure of new manufacturing facilities.
- Regulatory Insight: Proven track record of leading regulatory inspections and managing analytical transfer in cell therapy or related fields.
- Skills & Competencies: Strong analytical, problem-solving, and critical thinking skills. Excellent teamwork, interpersonal skills, and the ability to manage shifting priorities in a fast-paced environment.
Why Join? 🌟
- Competitive Compensation: Salary range of $170,000 to $240,000 with equity options.
- Comprehensive Benefits: Highly subsidized medical, dental, and vision plans, 401(k) matching, free EV charging, and onsite lunches.
- Relocation Support: Within 30 days of the start date, a relocation budget of $5,000 to $10,000 will be provided.
- Professional Growth: Be part of a high-performing team in a cutting-edge startup environment, driving the future of cell therapy.
