Director of Technical Operations

4 weeks ago


California, United States Pave Talent Full time

Job Summary:

Pave Talent is seeking an exceptional Director of Technical Operations to join our client's innovative team in the cell therapy industry. 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.

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