Associate Director, Gene Therapy Analytical Development - Bioassay

Job Description Summary

As a key member of the Analytical Development leadership team, this individual and their team will be accountable for analytical development activities for current and future programs including/not limited to product characterization, assay development/optimization, technology transfers (internal and external), testing support, investigation, and development of source documents for regulatory filings. Deep expertise in analytical development for gene therapies is essential. Growth mentality, scientific curiosity, passion to serve patients, and dedication to staff development and cultivating an open, collaborating culture are critical for the success of this role. Demonstrated people leadership is a must.

 

Job Description

Major accountabilities:

• Provide strategic, technical and scientific leadership to the gene therapy analytical development bioassay team, to develop, optimize, and characterize robust analytical methods and new technology evaluation and implementation. 

• Understand and characterize product critical quality attributes and develop assays to monitor and control these attributes  

• Collaborate closely with peer function teams and communicate complex technical topics and decisions within the department and to program teams.  Provide effective technical and business leadership at the R&D-CMC interface.  

• Ensure seamless transition of analytical capabilities from development to a GMP laboratory. 

• Work collaboratively with process development leadership to develop and/or analytical platforms to support company’s multi-product portfolio of development programs. 

• Provide strategic leadership and influence for the development and tech transfer of analytical methods to support manufacturing of gene therapy products across a network of internal and external manufacturing sites. 

• Develop, lead and coach a group of engineers/scientists through direct supervision and/or as matrix leader. 

• Author and review regulatory submissions and responses to questions from health authorities. 

Requirement:

• PhD or equivalent in Biology, Biochemistry, Bioengineering or related scientific discipline. 

• Minimum 5 years of relevant industry experience in analytical development for biological, preferably cell and gene therapy products is required.  

• Strong fundamental knowledge of cell biology, immunology and existing analytical technology is expected. Proven track record in utilization of special tools/equipment, lab automation tools and specialized facilities.  

• Demonstrated experience leading analytical development initiatives in support of cell or gene therapies, or protein biologics manufacturing, early- and late-stage.  

• Proficiency in strategic planning, team dynamic management, and technical leadership. 

• Proven leadership experience and strong people management skills with the desire and ability to deliver on objectives while developing people in a fast-paced environment. 

• Expertise in binding, cell-based assays and other