About The Position

WHY PATIENTS NEED YOU As a Senior Project Specialist, you will play a crucial role in improving patients' lives by providing project management support for the planning and execution of drug substance manufacturing product lifecycles projects. These projects may include new product introduction and launch, updates to manufacturing technology, enhancements for process robustness and advancement of supply assurance initiatives. Your contributions will directly impact the development and delivery of innovative solutions that enhance the quality of life for patients worldwide. Join us in our mission to bring breakthroughs that change patients' lives. WHAT YOU WILL ACHIEVE Under general direction of the manager, lead cross-functional teams in planning and executing drug substance manufacturing projects with site stakeholders. Work with the project team to establish project timeline and milestones to ensure delivery of key project objectives. Facilitate development of solutions for project timeline or technical challenges with area SMEs. Use your knowledge of global and local procedures for technology transfer, process validation, and related global regulatory submissions to review project compliance to program requirements and escalate for corrective actions if necessary. Implement improvements to site business processes relevant to technology transfer, process validation, and technical product lifecycles projects as needed. Prepare and verify data for reports or presentations with stakeholders or site project governances. Support continuous improvement efforts for PLP team business practices and programs.

Requirements

  • Applicant must have a bachelor's degree with at least 3 years of experience; OR a master's degree with more than 1 year of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
  • 4+ years of pharmaceutical/biopharmaceutical industry experience
  • Understanding of drug substance manufacturing process and process lifecycle management.
  • Strong Knowledge of GMP regulations
  • Strong organizational skills
  • Excellent oral and written communication skills.

Nice To Haves

  • Formal training in project management and prior project management experience
  • Experience using common project management tools, including MS Project or Planner
  • Interest in applying AI tools to support CI efforts

Responsibilities

  • Lead cross-functional teams in planning and executing drug substance manufacturing projects with site stakeholders.
  • Work with the project team to establish project timeline and milestones to ensure delivery of key project objectives.
  • Facilitate development of solutions for project timeline or technical challenges with area SMEs.
  • Use your knowledge of global and local procedures for technology transfer, process validation, and related global regulatory submissions to review project compliance to program requirements and escalate for corrective actions if necessary.
  • Implement improvements to site business processes relevant to technology transfer, process validation, and technical product lifecycles projects as needed.
  • Prepare and verify data for reports or presentations with stakeholders or site project governances.
  • Support continuous improvement efforts for PLP team business practices and programs.
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