QC Analyst II, second shift

For the QC Analyst II position at Landmark Bio, a Bachelor’s or Master’s degree in science, biology, chemistry, or a related field is essential. Applicants should have a minimum of 2 years of experience in a cGMP biotechnology manufacturing environment, ideally with hands-on experience in cell and gene therapy. Familiarity with analytical platforms such as PCR, flow cytometry, and HPLC will be advantageous.

As a QC Analyst II at Landmark Bio, your primary responsibilities include executing analytical test methods per cGMP regulations, supporting routine QC Bioanalytic activities, and participating in assay design and optimization. You will also collaborate with various internal teams and ensure compliance with industry standards, contributing significantly to our mission of advancing life sciences.

While direct experience in cell therapy is preferred for the QC Analyst II role at Landmark Bio, it is not strictly mandatory. Candidates with strong knowledge of cGMP requirements and experience in related areas such as analytical methods and biophysical characterization will also be considered. We value a proactive attitude and a willingness to learn.

Expect a collaborative and dynamic work environment at Landmark Bio. As a QC Analyst II, you will be part of a vibrant team that values innovation and teamwork. We encourage open communication and problem-solving to ensure that our cutting-edge therapies are developed and delivered efficiently while upholding the highest quality standards.

The QC Analyst II position at Landmark Bio operates on the second shift, typically from 2 PM to 10 PM. This schedule allows for a unique work-life balance while contributing to our critical initiatives in life sciences. Flexibility for occasional weekend shifts may be required, but they are typically planned in advance.

To ensure compliance with cGMP regulations, it’s important to stay updated on industry standards and guidelines. In your response, mention specific cGMP practices you have implemented in past roles, describe your experience with documentation process, and highlight any training you've conducted to promote compliance within your team.

Detail your hands-on experience with analytical platforms such as PCR, flow cytometry, or HPLC. Be prepared to discuss specific techniques you've employed, the types of assays you’ve developed, and any challenges you’ve encountered while working with these technologies. Emphasizing your problem-solving skills will strengthen your answer.

Discuss your approach to assay design and optimization by mentioning key factors like sensitivity, specificity, and reproducibility. Provide examples of how you’ve designed assays in the past, any modifications you made to improve outcomes, and how you validated those improvements through rigorous testing.

Explain your process of documenting analytical methods, highlighting your adherence to Good Documentation Practices. Discuss your experience with electronic lab notebooks, data retrieval, and version control. Emphasize your attention to detail and commitment to maintaining data integrity throughout the testing process.

Give an example of a specific project where you worked with stakeholders from manufacturing, process development, or quality assurance. Focus on the communication strategies you used to address objectives, any challenges faced, and the successful results achieved through teamwork and collaboration.

Discuss your time management and prioritization strategies, emphasizing your ability to stay organized in a high-pressure setting. You might want to mention tools or methods you've used to keep track of tasks, how you communicate with your team, and any experiences that showcase your ability to adapt to changing priorities.

Describe your systematic approach to conducting QC investigations, focusing on root cause analysis and corrective actions. Highlight any relevant software or methodologies you have used for managing change controls and ensure compliance while minimizing downtime and ensuring product quality.

Reflect on the challenges you’ve encountered in previous roles, such as maintaining strict compliance while meeting tight deadlines. Discuss how you overcame these challenges and how they have prepared you to handle similar situations at Landmark Bio, showcasing your problem-solving skills and resilience.

Detail your understanding of the collaboration needed with external contract testing labs, including overseeing testing protocols and quality standards. Share any past experience in managing projects with external partners, emphasizing communication and ensuring alignment with internal quality standards.

Communicate your enthusiasm for Landmark Bio's mission and your commitment to advancing life sciences. Align your skills and experiences with what you know about the role and company, and express how you see yourself contributing to the team’s success while growing in your career.