Senior Director, Upstream Process Development

As a Senior Director, Upstream Process Development at Ultragenyx, you'll spearhead the development of our pipeline products, ensuring that our late-stage antibody assets are maximally successful. This role requires managing technology transfers, troubleshooting manufacturing issues, and leading the upstream process development of biologics, including cell culture and process validation.

Candidates for the Senior Director, Upstream Process Development role at Ultragenyx should possess a PhD in Chemical Engineering, Biochemistry, or a related field, with at least 10 years of relevant experience. Alternatively, candidates with a Master's or Bachelor's degree along with additional years of experience can be considered. Leadership experience of at least 5 years is crucial, along with a proven track record in upstream process development of biologics.

At Ultragenyx, the environment is both collaborative and innovative. Senior Directors are expected to lead cross-functional teams and engage with external partners to achieve project milestones. The company also embraces a flexible work model, requiring onsite presence 2-3 days a week, which creates a dynamic and supportive workplace culture.

Ultragenyx places strong emphasis on professional and personal development. As a Senior Director in Upstream Process Development, you'll have ample opportunities to sharpen your skills, mentor a talented team, and influence the direction of innovative rare disease treatments. You can also expect to take part in leadership initiatives that enhance your career trajectory.

The typical annual salary range for the Senior Director, Upstream Process Development at Ultragenyx is between $251,500 and $310,700 USD. This position also offers an annual bonus and equity incentives, along with comprehensive benefits including generous vacation time, professional development plans, and employee wellbeing programs.

When answering this question, detail specific projects you've worked on, emphasizing your role in upstream process development and the outcomes of your contributions. Discuss the types of biologics or antibody assets you've worked with and your approach to technology transfers and process validation.

Demonstrate your problem-solving skills by providing examples of how you have successfully navigated challenges, such as troubleshooting deviations or managing timelines with external CDMOs. Describe your thought process and the methods you employ to ensure project milestones are met.

Discuss your leadership style and how it fosters a collaborative environment. Explain how you prioritize team development through mentoring and personal growth opportunities and provide examples of successful team dynamics that you've cultivated.

In this answer, convey your understanding of IND/IMPD/BLA/MAA filing processes and the significance of adhering to ICH guidelines. Share experiences where you've successfully navigated regulatory requirements and how they impacted the success of a program.

Emphasize the importance of communication and relationship-building in cross-functional teams. Offer insights on how you manage interactions with stakeholders from various departments, ensuring that everyone aligns on project goals and timelines.

Describe a specific situation where you led a technology transfer project. Highlight your role in the process, the challenges faced, and how you ensured that the transition was smooth and met all relevant benchmarks.

Share your enthusiasm for emerging technologies in biopharma that you believe can revolutionize upstream process development. Discuss any innovations you have been part of or observed and how they impact patient outcomes and efficiency.

Detail your organizational skills and techniques for staying focused on multiple projects simultaneously. Explain how prioritization, time management, and teamwork play essential roles in meeting deadlines.

Express your passion for making a difference in patients' lives. Share any personal experiences or observations that have driven your interest in rare diseases and how this motivation shapes your professional goals.

Discuss your method for creating and reviewing SOPs, highlighting collaboration with various teams to ensure compliance with quality standards. Mention how your attention to detail and regulatory knowledge enhance the support for robust and effective processes.