Manufacturing Contractor

As a Manufacturing Contractor at REGENXBIO, your responsibilities will include supporting the start-up of a new multi-product facility, maintaining a safety-first culture, collaborating with Quality to meet GMP standards, creating and revising GMP documentation, training new team members, and leading projects that support continuous improvement. You will also engage in upstream and downstream process operations, making a valued contribution to our manufacturing capabilities.

To qualify for the Manufacturing Contractor role at REGENXBIO, candidates should have at least a Bachelor’s degree or an Associate degree/High School Diploma with relevant cGMP experience. Prior experience in biologics, pharmaceutical, or vaccine manufacturing is preferred, with specific knowledge in cell culture, purification, or bulk formulation being a plus. Strong communication and teaching skills are also essential for effective training and collaboration.

At REGENXBIO, Manufacturing Contractors enjoy a collaborative and engaging work environment where teamwork and innovative thinking are encouraged. The culture emphasizes safety and accountability while providing the resources needed for professional growth and development. You’ll work alongside passionate colleagues who are dedicated to the shared vision of improving lives through gene therapy.

Yes! REGENXBIO values employee development and offers opportunities for career advancement. As a Manufacturing Contractor, you will have the chance to develop a broad skill set and engage in cross-functional projects, providing a strong foundation for future roles within the company. Your contributions will be recognized, and there are pathways to progress into more specialized or leadership positions.

The salary for a Manufacturing Contractor at REGENXBIO ranges from $29 to $35 per hour, depending on experience and qualifications. This competitive pay reflects our commitment to attracting top talent and rewarding the hard work of our team members.

When discussing your experience with GMP documentation, it's essential to highlight specific instances where you reviewed or authored standard operating procedures (SOPs) or batch records. Explain your understanding of the regulatory environment and emphasize your attention to detail and ability to maintain consistent quality documentation to meet compliance standards.

In your response, emphasize the importance of creating a safety-first culture. Share specific strategies you implement to encourage safety practices, such as regular safety training sessions, fostering open communication regarding hazards, and leading by example. Discuss how you would address safety concerns among team members effectively.

To ensure compliance with GMP standards, I would start by reviewing all applicable regulations and being familiar with internal SOPs. I would conduct regular audits of processes and documentation, maintain open communication with Quality teams for guidance, and participate in training sessions to ensure that all team members understand compliance requirements. Continuous improvement efforts are also vital to adapt to changing regulations.

In approaching training new team members, I would use a structured program, incorporating both theoretical learning and hands-on practice. I’d assess their existing skills and tailor training sessions to build their competencies gradually. I’d also encourage a collaborative atmosphere, where new hires can ask questions freely and learn from seasoned colleagues' experiences.

When discussing a continuous improvement project, highlight specific projects you've led, focusing on the problem you identified, the solution you implemented, and the results achieved. Discuss how you engaged cross-functional teams to drive change and enhance operational efficiency, as well as how you measured the project's success to showcase the tangible benefits.

For troubleshooting manufacturing process issues, I begin by gathering all relevant data to understand the problem fully. I would then conduct a root cause analysis, often collaborating with cross-functional colleagues. A systematic approach allows us to identify the issue accurately and implement effective solutions. Documenting this process is crucial for compliance and future reference.

Prioritizing tasks in a fast-paced manufacturing setting is about recognizing urgent issues versus longer-term goals. I typically assess which tasks impact safety, compliance, and production timelines the most. I utilize tools like prioritization matrices and daily planning to ensure efficient workflow while remaining flexible to adapt to sudden changes.

Teamwork is critical in manufacturing operations; strong collaboration leads to better problem-solving and innovation. I believe in building a team environment where everyone feels valued and contributory. Sharing knowledge and skills not only increases efficiency but fosters a supportive atmosphere where challenges can be tackled as a group.

In answering this question, express your admiration for REGENXBIO’s mission and core values. Discuss their commitment to innovative science and how you see yourself contributing to their vision. Personal experiences or motivations that align with their goals can also demonstrate your genuine interest in the position.

To stay updated in manufacturing, I regularly attend industry seminars and webinars, read relevant publications and research articles, and participate in professional associations. Networking with peers and sharing insights allows me to be informed about industry trends and advancements, ensuring I bring current knowledge to my role.