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Head of Manufacturing, Biologics

Fremont, CA 94538

Posted: 06/27/2025 Employment Type: Direct Hire Job Category: Manufacturing Job Number: 4526

Job Description

Our client is seeking a dynamic, experienced Head of Manufacturing to lead and expand their GMP manufacturing operations. This leader will oversee manufacturing activities for clinical and commercial biologics production, ensuring operational excellence, regulatory compliance, and continuous improvement in a fast-paced and growing environment.

Essential Duties and Responsibilities:
  • Lead and manage all aspects of GMP manufacturing operations, including upstream and downstream production.
  • Oversee manufacturing planning, scheduling, and execution to meet project timelines and quality standards.
  • Ensure compliance with cGMP regulations, internal SOPs, and client-specific requirements.
  • Develop, mentor, and manage the manufacturing leadership team and broader staff to foster a high-performing, collaborative culture.
  • Collaborate closely with Process Development, Quality, Facilities, and Program Management to ensure seamless technology transfer and campaign execution.
  • Drive continuous improvement initiatives in manufacturing processes, operational efficiency, and cost management.
  • Contribute to strategic site planning and capacity expansion efforts, including facility design input and organizational scaling as needed. 
  • Establish and track key performance indicators (KPIs) for manufacturing operations.
  • Serve as a key point of contact for clients during technical discussions, audits, and business development activities.
Working Conditions:
  • This position requires work in an office and GMP manufacturing environment. The employee must occasionally lift and or move up to 20 pounds independently.  

Requirements / Qualifications:
  • Bachelor’s degree in engineering, Biology, Biochemistry, or related field; advanced degree (MS, PhD, MBA) preferred.
  • 20+ years of experience in biologics manufacturing within a GMP environment, with at least 5 years in senior leadership roles.
  • Strong expertise in mammalian cell culture, protein purification, and single-use technologies.
  • Demonstrated success in building and scaling manufacturing organizations and facilities.
  • In-depth knowledge of cGMP regulations, ICH guidelines, and regulatory agency expectations (FDA, EMA).
  • Proven leadership abilities with a track record of developing high-performing teams.
  • Excellent communication skills and ability to work collaboratively across all organizational levels.
  • Prior CDMO experience is strongly preferred.
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Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!