Mantell Associates
Mantell Associates is currently partnered with a biopharma CDMO with a focus on advanced therapeutics and critical medicines. They are seeking a Plant Head to join their growing leadership team.
Plant Head – Responsibilities:
- Lead the operations of cutting-edge sterile Formulation, Fill & Finish biologics manufacturing facility
- Implement the company Business Strategy and translate it into the facility Manufacturing Strategy
- Lead the Tech Transfer of the Formulation, Filling, Visual Inspection, Packaging and analytical QC tests methods for at least 5 biological products as per the Clients Quality and Tech Transfer standards
- Lead the ambitious facility operations scale-up from current Packaging operations with 70 employees and annual output of 2 million units to the Formulation and Fill & Finish operations with more than 200 employees and an expected annual output >25 million units
- Support the company to secure long-term “Tech Transfer & CDMO agreements” with the biologics Clients
- Support the company future increase of the Formulation and Fill / Finish capacities via an extension of the current facility and/or the set-up of a new facility
Plant Head – Requirements:
- Master’s degree in Life Sciences (e.g., pharmacy, biology, chemistry) or in Technology (engineering, bioengineering, biotechnology) or equivalent by experience
- Advanced degrees are strongly preferred (MBA, Ph.D.)
- Deep understanding of the science and technology underlying biologicals manufacturing
- In-depth knowledge of QA standards, SFDA and European cGMP regulations and pharma industry best practices
- Deep knowledge of the regulatory / licenses requirements and biologics registration processes
- Deep understanding and practices of biologics DP Manufacturing, QA / Validation, Supply Chain, Engineering & Maintenance, Regulatory Affairs
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.