Associate Director, CTTO DP Labs

Role Summary

Associate Director, CTTO DP Labs, based in Warren, NJ. This role leads a team of engineers who design and execute experiments, evaluate data, and draft technical reports in support of process improvements, investigations, and manufacturing process changes within BMS cell therapy GMP facilities. The Associate Director will oversee testing, support implementation of operational improvements, resolve manufacturing process investigations, and develop a team of engineers into roles with increasing lab and cross-functional responsibility.

• Direct management of a team of engineers; providing technical leadership for experimental design, execution, data analysis, report writing and people leadership for the team.
• Collaborate and coordinate with cross functional teams (Manufacturing, Quality, Regulatory, Site MS&T, Analytical teams, and other CTTO teams) to achieve GMP process solutions.
• Manage the support of manufacturing related investigations, ensuring compliance with internal standards and regulatory requirements.
• Provide technical leadership for manufacturing process changes and improvement activities, and/or author technical reports for process changes and improvements.
• Provide technical content for significant documents such as process validation and/or process comparability assessments, and author content for regulatory submissions.
• Leadership and mentorship for direct reports to support business goals and career development.

• Required:
  
  Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in cell therapy and/or biologics upstream manufacturing. Minimum of a Bachelor's with 14+ years or a Master's degree with 12+ years or Ph.D. degree with 10+ of experience
• Required:
  
  Prior direct management experience
• Required:
  
  Strong understanding of bioprocess unit operations, especially cell culture.
• Required:
  
  Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations
• Required:
  
  A strong mindset for high-quality, meticulous, and consistent execution of manufacturing processes and/or analytics
• Required:
  
  Excellent written and verbal communication skills. Ability to convey complex technical issues to diverse audiences including internal teams, external partners, and health authorities.
• Required:
  
  Strong interpersonal skills to work across multiple stakeholders and customers.
• Required:
  
  Experience of data handling and applied statistics
• Preferred: 2-3 years of experience in cell therapy technical operations.
• Preferred: 2+ years of direct management experience.
• Preferred:
  Experience with commercial product support, i.e. post-marketing commitments, life-cycle changes, and comparability.
• Preferred:
  Experience executing investigations in support of commercial manufacturing.
• Preferred:
  Proficiency utilizing organizational and efficiency products and strong experience with statistical software (R, JMP, Minitab).

• Bioprocess operations knowledge, especially cell culture
• Data handling and applied statistics; proficiency with statistical software (R, JMP, Minitab)
• Excellent written and verbal communication; ability to convey complex technical issues to diverse audiences
• Strong interpersonal skills and ability to work across multiple stakeholders
• Technical leadership and mentoring capabilities