Demo

Associate Director, Engineering Bio Technology Solutions (BTS)

Flagship Kansas
KS Full Time
POSTED ON 4/15/2025
AVAILABLE BEFORE 5/15/2025

Job Description

Welcome to our team :

The Associate Director, Engineering BTS will work within the Site Support (SS) team in the Bio Technology Solutions (BTS) department. The Associate Director will provide management to a team of scientists and / or engineers, focusing on vaccine and biopharmaceutical process improvement and troubleshooting in support of commercial antigen / antibody manufacturing and sterile biopharmaceutical product fill-finish, and Technology Transfer. The BTS-SS team is also responsible for supporting the BTS Process Development (PD) team during new process / product introductions. You will cooperate with colleagues from various departments including Operations, Engineering, Quality Control / Assurance, Supply Chain, Regulatory Affairs, Safety, and Research.

Key Responsibilities :

  • Manage and lead a team with a focus on process improvements.
  • Optimize and troubleshoot manufacturing processes for microbial, virus, or cell cultures followed by purification / concentration and blending / fill of veterinary vaccines and biopharmaceuticals.
  • Support technology transfer within or between manufacturing sites.
  • Resolve manufacturing challenges while ensuring timelines meet customer requirements regarding safety, quality, cost-efficiency, and consistency.
  • Conduct technical investigations, validation, and process improvement projects.
  • Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to understand and resolve root causes.
  • Ensure sound scientific data / literature drives every decision / recommendation.
  • Perform development, introduction, and / or testing of new technologies as needed.
  • Collaborate with Research, Process / Analytical Development, Manufacturing, and other departments to ensure commercial products meet needs.
  • Demonstrate knowledge of current USDA regulatory guidelines.
  • Develop project charters and plans, aligning with sponsors and stakeholders.
  • Utilize project management skills to define deliverables, roles, responsibilities, and risk management.
  • Coordinate and track team activities, communicate project risks and status to stakeholders, and escalate challenges and opportunities as needed.
  • Assure consistent application of standardized work, engineering controls, and process analytical technology.
  • Author experimental protocols and reports in support of evaluations.
  • Create and update technical and manufacturing documents necessary for investigations and validations.
  • Display leadership behaviors and demonstrate high emotional intelligence.
  • Contribute to international projects and collaborate with external partners if required.
  • Actively contribute to the improvement of departmental activities.
  • Train and guide other employees and / or interns.
  • Perform off-shift work as needed.

Minimum Qualifications :

  • Bachelor of Science in Chemical Engineering, Biotechnology, Mechanical Engineering, Biochemistry, Protein Chemistry, or related field with at least 8 years of experience in vaccine and / or biopharmaceutical development, process / product development through validation, management, technology transfer, and / or biological manufacturing.
  • OR Master of Science degree with at least 6 years of experience.
  • OR Doctoral degree with at least 3 years of experience.
  • Required Experience and Skills :

  • Excellent team leadership skills.
  • Excellent written and oral communication skills.
  • Excellent project management, documentation, and writing skills.
  • Strong problem-solving skills and a hands-on approach.
  • Ability to work in multidisciplinary and international teams.
  • Knowledge of FMEAs and technology transfer leadership.
  • Experience in bioprocess development, scale-up, validation, and process improvements.
  • Working knowledge of USDA or FDA regulations.
  • Understanding of GMP requirements for manufacture and testing of sterile / parenteral products.
  • Knowledge management skills and excellent technical writing abilities.
  • Preferred Experience and Skills :

  • Process Validation.
  • Regulatory Affairs.
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