External Site Lead, Global External Manufacturing

As an External Site Lead at Biogen, you'll have a diverse set of responsibilities that center around overseeing the manufacturing operations at external supplier sites. This includes analyzing scientific data sets, managing process controls, and ensuring compliance with quality and regulatory standards. You'll also be tasked with managing technology transfer deliverables, solving complex manufacturing issues, and leading efforts for continuous improvement. Your role is vital for the efficiency and success of our CDMO partnerships.

To be considered for the External Site Lead position at Biogen, you need a Bachelor's degree in a relevant field and at least 10 years of experience in pharmaceutical and biologics manufacturing. Alternatively, a Master's degree with 8 years or a PhD with 5 years of experience will also qualify you. Strong expertise in CDMO relationship management, compliance with cGMP regulations, and a proven track record in project management are essential for this role.

The External Site Lead plays a critical role in achieving Biogen's business objectives by ensuring that manufacturing processes meet quality and efficiency standards. This role involves collaborating with senior leadership to align on manufacturing objectives, driving optimization initiatives, and ensuring supplier performance meets our rigorous cGXP standards. Your leadership and technical expertise directly enhance the company's capabilities in delivering life-changing medicines.

As an External Site Lead at Biogen, you will enjoy a flexible remote work environment, allowing you to manage your responsibilities from anywhere in the United States. The culture at Biogen fosters collaboration and innovation, encouraging you to work closely with cross-functional teams. You’ll be part of a dynamic and inclusive workplace that values diverse perspectives and contributions, making every day a rewarding experience.

At Biogen, the External Site Lead role offers significant opportunities for professional growth and development. You'll gain valuable experience leading diverse teams and managing critical supplier relationships. Biogen is committed to developing its talent, providing various learning and development resources. Your contributions will not only impact your career trajectory but will also play a part in advancing our mission of delivering innovative healthcare solutions.

In managing supplier relationships within a CDMO setting, it's essential to foster open communication and establish clear expectations from the outset. I emphasize regular check-ins and feedback sessions to maintain transparency and address any issues promptly. Ensuring alignment on objectives and compliance with regulations plays a critical role in building trust and driving successful partnerships.

During my previous role, I encountered a significant issue with a batch that didn't meet quality standards due to unforeseen deviations in the manufacturing process. I led a cross-functional team to conduct a root cause analysis, which revealed gaps in our change control protocols. By implementing corrective actions and enhancing our monitoring techniques, we were able to resolve the issue and prevent recurrence.

For continuous process improvement, I employ methodologies such as Lean and Six Sigma to analyze workflows and identify inefficiencies. Regularly collecting and analyzing data helps in pinpointing areas for improvement, while fostering a culture of collaboration encourages team members to contribute innovative ideas actively. Implementing pilot projects to test changes allows us to gauge effectiveness before wider rollout.

To ensure compliance with health regulations, I prioritize staying informed about current cGMP guidelines and industry standards. Regular audits and training sessions for the team reinforce our practices and help identify areas needing attention. I also advocate for a strong culture of accountability, encouraging team members to report concerns immediately so we can address them proactively.

My approach to managing technical project management issues combines analytical skills with strong organizational techniques. I first gather all relevant data to understand the challenge and its impact on project timelines. Engaging affected stakeholders early ensures agreed-upon actions to resolve the issue. Setting clear project goals and monitoring progress closely keeps us on track.

Technology transfer is pivotal in my role as it encompasses ensuring seamless transitions of manufacturing processes from one facility to another. I ensure that protocols are well-documented and that knowledge is effectively shared among teams. Validating processes during technology transfer helps mitigate risks and ensures that consistency in quality is maintained throughout.

I lead continuous improvement initiatives by creating a structured framework where team members can contribute their insights. Establishing measurable goals for improvements allows us to track success and progress. I also encourage a feedback loop, where we can learn from both successes and setbacks, further enhancing our manufacturing processes.

My experience in analyzing scientific data sets involves employing statistical methods to derive meaningful insights that inform decisions. I utilize software tools for data visualization, which helps present findings clearly to stakeholders. Regularly interpreting data ensures we make informed decisions that enhance our operational efficiency and product quality.

Handling conflicts within cross-functional teams requires empathy and clear communication. I approach conflicts by facilitating open discussions where all parties can express their perspectives. Finding common ground often involves collaborative problem-solving, affirming the collective goal of team success while navigating individual concerns.

Relationship management is crucial in a CDMO environment because it directly impacts collaboration, operational efficiency, and the overall success of projects. Strong, trusting relationships with suppliers lead to better compliance adherence, enabling quicker resolution of issues. Healthy partnerships foster a proactive rather than reactive approach to challenges, ensuring that we deliver high-quality products timely.