Senior LIMS Scientist, QC
AGC Biologics
Dato: for 3 uger siden
By: København, Region Hovedstaden
Kontrakttype: Fuld tid
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
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 the position, feel free to contact Team Leader, Anders Mellerup, at [email protected].
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
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.
- 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.
- 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.
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 the position, feel free to contact Team Leader, Anders Mellerup, at [email protected].
Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.
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