Mantell Associates is partnered with a leading global CDMO, who is seeking a highly skilled and experienced Group Leader, Formulation Development & Manufacturing to take operational leadership within its Drug Product Development & Manufacturing (DDM) business unit.
This role is pivotal for delivering high-quality formulation and manufacturing solutions that support early phase clinical development through GMP production.
Group Leader Formulation Development & Manufacturing - Responsibilities:
* Lead, plan and oversee GMP production projects from formulation development through clinical batch manufacturing - ensuring deliverables are on time, within budget, and compliant with GMP standards
* Translate project specs from Project Managers into actionable tasks for Development & GMP teams; supervise Associate Scientists in formulating and manufacturing oral and injectable dosage forms
* Develop and refine formulation strategies, select excipients and delivery formats, and guide tech transfers from R&D to GMP production
* Ensure documentation quality: master batch records, batch records, technical reports, GMP manufacturing reports; coach the team to maintain standards in non-conformance management and quality assurance alignment
* Coordinate with QA / QP and supply chain to ensure availability of starting materials, manage deviations, and resolve GMP / compliance issues swiftly and effectively
* Act as scientific & technical problem-solver: troubleshoot formulation, process, equipment, and compliance challenges when they arise
* Represent the Formulation & GMP Manufacturing team in project core meetings; provide scientific input to clients and internal cross-functional teams
Group Leader Formulation Development & Manufacturing - Requirements:
* MSc or PhD in Pharmaceutical Sciences, Chemical Engineering, or a related discipline; significant hands-on experience in formulation development and GMP manufacturing
* At least 8-10 years in the pharmaceutical industry, including experience working with oral and/or injectable dosage forms in GMP production settings
* Proven leadership experience managing and mentoring scientific teams in both R&D and GMP production environments
* In-depth knowledge of GMP regulations, drug product formulation, process optimization, tech transfer and regulatory documentation practices
* Strong organizational, communication, and scientific reporting skills; capable of driving technical excellence in a growing team
* Fluent in English; additional proficiency in Dutch/French/German is an advantage
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.