Mantell Associates is partnered with a globally respected Biologics/Biosimilar CDMO, who is seeking an experienced and strategic Head of Manufacturing to lead large-scale biologics and biosimilar production operations at key US sites in Boston or North Carolina.
Reporting to senior leadership, this role is pivotal in delivering high-quality, GMP-compliant manufacturing while driving operational excellence and capacity growth.
Head of Manufacturing - Responsibilities:
- Provide strategic and operational leadership for biologics and biosimilar manufacturing activities, ensuring adherence to cGMP standards, safety protocols, and regulatory expectations across facilities
- Oversee daily manufacturing operations, including upstream cell culture/fermentation, downstream purification, formulation, and fill/finish processes
- Collaborate with cross-functional partners in Quality, Technical Ops, Engineering, and Supply Chain to ensure seamless production execution and continuous improvement of processes
- Drive execution excellence for current and pipeline client programs from clinical through commercial supply, meeting timelines, cost, and quality targets
- Ensure facility readiness and operational resilience through process optimization, capacity planning, risk management, and robust staffing strategies
- Mentor, develop, and lead high-performing manufacturing teams, fostering a culture of accountability, continuous improvement, and operational discipline
- Champion data-driven decision making and establish clear performance metrics (KPIs) to evaluate operational effectiveness and drive informed actions
- Represent manufacturing leadership in cross-site and executive forums, contributing to capacity planning, site investments, and long-term strategic initiatives
Head of Manufacturing - Requirements:
- Bachelor’s or advanced degree in Engineering, Life Sciences, Bioprocessing, or related discipline; advanced degree preferred
- 10+ years of progressive experience in biologics or biosimilar manufacturing leadership roles, preferably within a CDMO or biopharmaceutical organisation
- Strong understanding of GMP, quality systems, regulatory compliance (FDA/EMA), and manufacturing best practices for biologics across multiple modalities
- Demonstrated track record of leading multi-site manufacturing operations with responsibility for team leadership, throughput delivery, and operational excellence
- Proven ability to implement continuous improvement methodologies (Lean, Six Sigma, Operational Excellence) in a regulated manufacturing environment
- Excellent communication, collaboration, and stakeholder engagement skills, with ability to influence teams and senior leaders across functions
- Strategic leader with hands-on operational experience and ability to balance high-level vision with execution rigor
- Based in or willing to relocate to Boston, MA or North Carolina, USA, with ability to be onsite as required
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
