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).