Job Details

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:

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

Minimum Qualifications:

1. 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.
2. OR Master of Science degree with at least 6 years of experience.
3. OR Doctoral degree with at least 3 years of experience.

Required Experience and Skills:

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

Preferred Experience and Skills:

1. Process Validation.
2. Regulatory Affairs.