Job Description

Mantell Associates is currently partnered with one of the most innovative CMO organisations who are searching for a Technical Product Lead to join their team.

Technical Product Lead - Responsibilities:

• Oversee proposal development, facility fit assessments, and risk analyses to support the introduction of new manufacturing programs.
• Facilitate seamless transfer of processes from development to manufacturing, including authoring batch records and SOPs.
• Deliver hands-on process training to manufacturing teams to ensure readiness for GMP production.
• Develop and manage project plans, timelines, and deliverables across clinical and commercial programs.
• Serve as the main point of contact for clients, ensuring clear communication and high-quality service delivery.
• Identify and implement systems and strategies to enhance GMP planning, scheduling, and execution.
• Support investigations, CAPA implementation, and change control processes to maintain regulatory compliance.
• Collaborate cross-functionally to identify and execute technical and business process improvements.

Technical Product Lead – Requirements:

• Bachelor’s degree in a scientific or engineering discipline, or equivalent experience
• Minimum of 5 years of experience in biotech or pharmaceutical manufacturing operations
• At least 5 years of experience managing projects in a regulated life sciences environment
• Familiarity with aseptic operations and drug product manufacturing processes is strongly preferred
• Strong working knowledge of GMP regulations and compliance standards
• Ability to analyze manufacturing data and drive improvements based on insights
• Excellent written and verbal communication skills, including technical writing proficiency
• Proven ability to work effectively across cross-functional teams and manage multiple priorities in a fast-paced setting.

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at 44 (0)20 3854 7700.

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