Deputy General Manager- R&D Gene Therapy

Role & responsibilities-

• Provide strong expertise in analytical characterization and product characterization packages for Cell and Gene Therapy (CGT) products.
• Strong expertise in experimental design, CQA determination and designing analytical strategy for CGT products.
• Collaborate with research and process development to develop fit for purpose analytical methods for target optimization and manufacture process development.
• Collaborate with quality to develop and qualify analytical methods for product release and stability.
• Oversee and lead a team of scientists and technical specialists in the evaluation and implementation of analytical procedures relevant to product characterization and qualification testing.
• Establish strong relationships and collaborations across multiple functions as well as externally with partners.
• Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods.
• Recruit and mentor talent and manage analytical sciences function with needed capabilities.

Education:

• Master's degree or PhD in related field.
• Ph.D. (or equivalent degree) and 9+ years of relevant post-doctoral employment experience, or
• Master's Degree (or equivalent degree) and 12+ years of relevant employment experience

Experience:

• Experience in CMC analytical development of gene & cell therapies, or biologics products
• Strong expertise in biologics characterization is a must
• Experience in a broad variety of analytical techniques
• Excellent problem-solving skills
• Excellent communication skills to communicate across multiple functional areas