Senior LIMS Scientist, QC

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Are you an experienced Quality Control (QC) professional and passionate about driving digital transformations? Do you have a strong understanding of data management and a drive to lead implementation efforts? If so, this Senior Scientist position in our QC LIMS Team could be the perfect opportunity for you! You will be joining a dynamic team environment where your expertise can make a significant impact for QC and AGC Biologics!

About QC & The QC LIMS Team:

The QC organization ensures the quality and compliance of clinical and commercial products. This involves a wide range of activities, from inspecting incoming raw materials to monitoring production processes and releasing finished products. We work in an international and customer-oriented manner to ensure the fast and reliable manufacturing of medicines for our customers.

The current position is located in the QC LIMS team. The team is responsible for supporting and improving LIMS, which has a critical role in managing laboratory data and sample flows for both QC and production. The team works to ensure that the LIMS system meets the constantly evolving needs of the QC and production organizations. This includes configuring, maintaining, and optimizing the system to support efficient data integration, streamlined processes, and compliance with applicable regulations.

The Role of a Senior LIMS Scientist:

As a Senior LIMS Scientist, you will play a key role in leading the implementation of new LIMS functionalities. This involves taking ownership of the entire implementation lifecycle, from the initial planning stages to the final deployment and post-implementation support. You will work closely with stakeholders, including laboratory personnel, IT teams, and management, to gather requirements, design solutions that address their specific needs, and ensure successful deployment of the new functionalities. This role requires a strong understanding of project management principles and methodologies, including the ability to select the proper tools and techniques for the task at hand, and the ability to effectively communicate technical information, both verbally and in writing, to technical and non-technical audiences. A key aspect of this role is also to have a solid understanding of how QC and Manufacturing operate, including their respective workflows, data requirements, and regulatory obligations.

Your Key Responsibilities:

• Lead the implementation of new LIMS functionalities, from requirements gathering to deployment.

• Collaborate with QC and Manufacturing teams to understand their needs and translate them into LIMS solutions.

• Participate in designing solutions to meet business requirements.

• Develop and maintain LIMS documentation, including SOPs, work instructions, and training materials.

• Participate in LIMS validation activities.

• Provide training and support to LIMS users.

Your Profile:

• A relevant scientific degree (e.g., chemistry, biotechnology, pharmacy, or a related field).

• 5+ years experience of working in a GMP environment with change control

• Excellent communication and interpersonal skills, with the ability to effectively interact with stakeholders at all levels.

• Strong analytical and problem-solving skills.

• Experience with system validation in a regulated environment.

• Experience working with LIMS systems in a QC environment.

What We Offer:

• An exciting and challenging position in a growing company where digitalization is catching up with the general growth of the company.

• Opportunities to lead and contribute to critical LIMS projects with a dedicated and skilled team.

• Competitive salary and employment terms.

• Opportunities for professional and personal development.

Your Application:

We look forward to hearing from you! Please submit your application as soon as possible! We treat the applications as we receive them and conduct interviews with qualified candidates. If you have any questions about