Head of Manufacturing

Mantell Associates; Massachusetts; Hybrid; USD 150,000 - 200,000; Full time

Job summary

A leading CDMO in the United States is seeking a Head of Manufacturing to lead biologics and biosimilar production. This role requires strong leadership and a deep understanding of GMP standards and regulatory compliance. The successful candidate will have over 10 years of experience in manufacturing leadership within biopharmaceutical organizations. You'll be responsible for strategic operational leadership, driving excellence in production and team performance. The position allows for relocation to Boston, MA or North Carolina and involves onsite work as required.

Qualifications

• 10+ years of experience in biologics or biosimilar manufacturing leadership roles.
• Strong understanding of quality systems and regulatory compliance.
• Track record of leading multi-site manufacturing operations.

Responsibilities

• Provide operational leadership for manufacturing activities.
• Oversee daily manufacturing operations including cell culture and purification.
• Collaborate with cross-functional partners for production execution.

Skills

Leadership in biologics manufacturing

GMP knowledge

Regulatory compliance

Continuous improvement methodologies

Excellent communication and collaboration skills

Education

Bachelor’s or advanced degree in Engineering, Life Sciences, or related discipline

Job description

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 [phone].