Technical Product Lead Job at Mantell Associates, Anaheim, CA

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  • Mantell Associates
  • Anaheim, CA

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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