Associate Director, Biologics Manufacturing Management

As the Associate Director of Biologics Manufacturing Management at Ultragenyx, your core responsibilities include overseeing external manufacturing for Plasmid DNA and aseptic drug products, supporting biologics CMC strategies, ensuring compliance with industry regulations, and fostering relationships with contract manufacturing organizations (CMOs). You will also be involved in authoring global CMC filings and managing product risks, making your role crucial in delivering innovative biopharmaceuticals to patients.

To qualify for the Associate Director of Biologics Manufacturing Management role at Ultragenyx, candidates should have a Bachelor’s degree in Pharmaceutical, Biological, or Bioengineering Sciences, with 10 or more years of relevant experience in the biotech or pharmaceutical industry. Ideally, you should possess substantial technical experience in bioprocess manufacturing, particularly with complex biologics. Additional experience in CMC and product development, along with strong project management and collaboration skills, will be beneficial.

Ultragenyx cultivates a supportive culture focused on learning and growth, especially within the Associate Director of Biologics Manufacturing Management role. Employees can thrive through collaborative teamwork, participation in professional development plans, and access to wellness benefits. The company's commitment to inclusivity and the well-being of its employees creates an environment where everyone can contribute positively towards life-changing treatments for patients.

In the Associate Director role at Ultragenyx, you will manage a variety of projects related to the manufacturing lifecycle of biologics. This can include overseeing the production of Plasmid DNA, directing CMO compliance to good manufacturing practices (cGMPs), and facilitating tech transfers and change control processes. Moreover, you will actively participate in troubleshooting and quality investigations, ensuring the highest standards in all biopharmaceutical products developed by Ultragenyx.

As an Associate Director at Ultragenyx, you can expect travel commitments of up to 25%, both domestic and international, as well as occasional on-site activities at manufacturing locations. This flexibility allows you to oversee the operations of CMOs effectively while also accommodating your personal work-life balance.

In answering this question, emphasize your previous interactions and experiences managing relationships with CMOs. Highlight specific projects where you ensured compliance with cGMP standards and how you facilitated collaboration to drive successful project outcomes.

When responding, choose a specific example showcasing your problem-solving skills. Explain the situation, your approach to identifying the issue, the steps you took to resolve it, and the positive outcome that resulted from your actions.

Discuss methods you have used to identify and assess risks in biomanufacturing. This could involve implementing continuous monitoring systems, conducting regular compliance audits, and fostering open communication with your teams to ensure challenges are addressed promptly and effectively.

Emphasize your familiarity with regulations like cGMP and how you stay updated on industry standards. Explain your methods for ensuring comprehensive documentation, regular training of staff, and rigorous review processes that help maintain compliance.

Outline your project management philosophy, focusing on organization, communication, and collaboration. Provide examples of how you've successfully led cross-functional teams towards project milestones and strategies to manage timelines and budgets effectively.

Convey your ability to prioritize by explaining your decision-making process. Discuss how you assess project urgencies based on deadlines and implications for patient outcomes, while also ensuring that all stakeholders are aligned throughout the process.

Acknowledge potential challenges such as maintaining communication across multiple CMOs or navigating complex regulatory landscapes. Discuss how your proactive approach and experience will equip you to address these challenges effectively.

Explain your methods for building an inclusive team environment. You might highlight your communication strategies, regular check-ins, and promoting a culture of respect that encourages team members to share ideas and insights.

Talk about your commitment to continuous improvement by mentioning specific methodologies such as Lean or Six Sigma. Provide examples of past initiatives you've led that resulted in significant improvements in efficiency or quality.

Share a personal connection or intrinsic motivation that drives your passion for working in the rare disease field. Discuss the importance of transforming patient lives and how this purpose energizes your daily contributions to the field.