Contamination Program Lead

As a Contamination Program Lead at Legend Biotech, you will be responsible for creating and maintaining the contamination control strategy for our Cell Therapy facility. Your main duties will include establishing the program, aligning it across different sites, and leading presentations during health authority inspections, ensuring compliance with all necessary regulations.

To be a successful candidate for the Contamination Program Lead role at Legend Biotech, you will need a Bachelor’s Degree in Engineering or Microbiology, along with over 8 years of experience in a Technical, Engineering, or Operations role within a GMP production environment. Experience in biotechnology or cell therapy is highly preferred.

The Contamination Program Lead plays a crucial role in facility expansion activities by ensuring a robust contamination strategy is in place. You'll assess and integrate your contamination approaches with existing processes to maintain the highest standards of cleanliness and compliance as the facility grows.

A strong microbial background, deep knowledge of cleaning and sanitizing agents, and excellent organizational skills are essential for the Contamination Program Lead at Legend Biotech. You should also be self-motivated, able to mentor junior team members, and possess strong communication skills to collaborate effectively across teams.

The Contamination Program Lead ensures compliance with regulatory requirements by assessing change controls, conducting trend reports, and reviewing SOPs for contamination impact. Your understanding of EU GMP Annex 1 and your ability to apply these regulations practically will be vital in this role.

In answering this question, highlight specific strategies you've developed or implemented in past roles. Discuss your understanding of regulatory standards and how you've ensured that facilities align with those requirements.

Share examples of how you've successfully balanced competing priorities in the past. Discuss your organizational skills and the tools you use to ensure all tasks are completed on time without compromising quality.

Explain your background in microbiology and how it applies to contamination control. Provide examples of how this knowledge has helped you troubleshoot issues or develop effective sanitation protocols.

Think of a specific incident and explain the situation, your actions, and the outcomes. This will demonstrate your leadership and problem-solving skills in high-stress environments.

Discuss your philosophy on mentorship and provide examples of how you’ve trained or guided junior staff. Highlight your commitment to collaboration and team success as part of your answer.

Discuss specific methods you employ to stay informed, such as attending industry conferences, partaking in webinars, or following relevant publications. Show your proactive approach to maintaining compliance.

Provide a detailed explanation of your methodology for conducting risk assessments. It’s vital to discuss how you analyze potential contamination sources and develop mitigation strategies.

Share techniques you use to foster communication and collaboration among team members from various departments, emphasizing the importance of teamwork in achieving contamination control goals.

Focus on your experience designing, conducting, and reviewing cleaning efficacy studies. Explain how you validate results and the importance of these studies in maintaining compliance.

Reflect on past challenges you've encountered. Describe your problem-solving process and what you learned from overcoming those challenges, emphasizing resilience and adaptability.