Associate Director, CMC-Pharma Product Group

As a discipline expert, drives and owns New Product Tech-Transfer of Toxin Pipeline products into Abbvie commercial facilities.  The successful candidate will be the principal technical/scientific interface between sending site (typically R&D) and the commercial receiving site.   

Responsibilities:

• Responsible for ensuring new toxin products and manufacturing processes are developed and ready for routine commercial manufacturing
• Ensures that the New Product’s Critical Quality Attributes, Critical Processing Parameters and, Critical Material Attributes are clearly understood, defined and characterized.
• Ensures that a robust Design Space for the proposed manufacturing process is delivered as part of any transfer to commercial operations.  
• Develops and maintains timelines for Tech-Transfer activities ensuring they meet functional and company goals.
• Collaborates with experts within Operations and R&D to integrate scientific and engineering objectives into activities associated with development of new/improved products or technology.
• Proactively advises and shares knowledge and expert opinions with subordinates, peers, and senior management. Mentors and trains functional colleagues and assesses current and emerging business challenges enabling functional goal achievement.
• Ensures quality and effectiveness of key results of major project plans within function through sound design, early risk assessments, and implementation of fallback strategies.
• Applies imagination and innovation by creating, inventing, and implementing new or better approaches, alternatives and breakthrough ideas that are valued by customers within the function.
• Presents scientific concepts and results for functional scientific and non-scientific leaders/stakeholders as well as potential and existing partners. Maximizes impact and value of expertise.

• Bachelor’s Degree in Science related field with 16 years of related work; Master’s Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
• Proven ability to innovate with a history of new or improved product releases.
• Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.