Manager, QC Stability
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 passionate about leading people? Do you excel at creating a clear direction through complex challenges, guiding a team of skilled scientists and technicians? Do you want to be part of a company that helps customers bring biological products to market?
Whether you are an experienced leader or looking to take the next step in your career, you might be the person we are looking for. Join us in ensuring that applicable stability data is generated for a variety of products, from phase I/II and all the way to commercial production.
The QC Organization
The vacant position is placed in QC Support which is one out of four departments in our QC Organization: QC Bioassay, QC Chemistry, QC Microbiology, QC Support. QC is responsible for supporting the production of various biopharmaceuticals by controlling raw materials, performing analytical testing, planning, and executing stability programs and validating analytical methods according to regulatory guidelines from clinical phase I through phase III and commercial. We are also actively involved in the constant development and improvement of the work environment.
In QC Support we are in total 50 employees, both scientists and technicians, divided into Five groups: QC Samples & Service, QC Stability, QC Raw Materials, QC Equipment and QC LIMS. In the QC Stability group we are responsible for setting up stability studies in close collaboration with the clients, writing and reviewing customer specific stability protocols and reports, receiving and distributing samples to internal testing teams as well as managing shipment of samples to customers and external laboratories.
Role & Responsibilities
As a Manager for the QC Stability team you will be the direct leader for 8 skilled colleagues, represented by 5 scientists and 3 technicians in total. The Scientist group are the ones who establish the stability studies together with the clients and QA, and manage all relevant documentation (Change control, Protocols, Reports etc.). The Technician group handle the samples and coordinate with the internal testing teams and the shipping department, while supporting the laboratories to ensure that all testing is carried out in time.
By stepping into this leadership role, you will support and manage a team that in many ways function as a link between many different stakeholders, while remaining an independent team. There is a great team spirit, and the team members are driven by the changing pace and requests from the clients, always keeping high focus on delivering on time and at the right quality.
Key Responsibilities
The ideal candidate holds a master’s degree within life sciences and 2-3 years of leadership experience, it is an advantage if you have knowledge within the pharmaceutical industry and have worked in a GMP environment. In addition, we expect you to bring some of the following experiences and characteristics:
For further information regarding the position, please contact Director Sanne Bové Dehn, QC Support, at [email protected]. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidates are found, the add will close.
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 passionate about leading people? Do you excel at creating a clear direction through complex challenges, guiding a team of skilled scientists and technicians? Do you want to be part of a company that helps customers bring biological products to market?
Whether you are an experienced leader or looking to take the next step in your career, you might be the person we are looking for. Join us in ensuring that applicable stability data is generated for a variety of products, from phase I/II and all the way to commercial production.
The QC Organization
The vacant position is placed in QC Support which is one out of four departments in our QC Organization: QC Bioassay, QC Chemistry, QC Microbiology, QC Support. QC is responsible for supporting the production of various biopharmaceuticals by controlling raw materials, performing analytical testing, planning, and executing stability programs and validating analytical methods according to regulatory guidelines from clinical phase I through phase III and commercial. We are also actively involved in the constant development and improvement of the work environment.
In QC Support we are in total 50 employees, both scientists and technicians, divided into Five groups: QC Samples & Service, QC Stability, QC Raw Materials, QC Equipment and QC LIMS. In the QC Stability group we are responsible for setting up stability studies in close collaboration with the clients, writing and reviewing customer specific stability protocols and reports, receiving and distributing samples to internal testing teams as well as managing shipment of samples to customers and external laboratories.
Role & Responsibilities
As a Manager for the QC Stability team you will be the direct leader for 8 skilled colleagues, represented by 5 scientists and 3 technicians in total. The Scientist group are the ones who establish the stability studies together with the clients and QA, and manage all relevant documentation (Change control, Protocols, Reports etc.). The Technician group handle the samples and coordinate with the internal testing teams and the shipping department, while supporting the laboratories to ensure that all testing is carried out in time.
By stepping into this leadership role, you will support and manage a team that in many ways function as a link between many different stakeholders, while remaining an independent team. There is a great team spirit, and the team members are driven by the changing pace and requests from the clients, always keeping high focus on delivering on time and at the right quality.
Key Responsibilities
- Coach, develop and inspire team members.
- Ensure a smooth and respectful collaboration with stakeholders across functions.
- Ensure all activities follow cGMP and are performed in a safe working environment.
- Promote and support continuous improvement in the team and participate in cross functional lean initiatives.
- Support regulatory inspections and customer audits.
- As a person you approach leadership and team members with respect, openness, and positive energy.
The ideal candidate holds a master’s degree within life sciences and 2-3 years of leadership experience, it is an advantage if you have knowledge within the pharmaceutical industry and have worked in a GMP environment. In addition, we expect you to bring some of the following experiences and characteristics:
- Experience working in a GMP environment and knowledge of relevant guidelines.
- Structured Quality mindset.
- Good communication skills and the ability to effectively communicate with all stakeholders.
- Strong decision making and ‘can-do’ attitude.
- Able to quickly obtain the overview of multiple tasks in challenged situations, can prioritize and make quick and qualified decisions.
- Ability to build and maintain trust and psychological safety in the team.
- English skills, fluent spoken and written.
For further information regarding the position, please contact Director Sanne Bové Dehn, QC Support, at [email protected]. We treat the applications as we receive them, and conduct interviews with qualified candidates. When the right candidates are found, the add will close.
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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