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.
Sr. Manager for QC Raw Materials
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 be the person we are looking for! Join us in ensuring the continuous delivery of Raw Materials for production!
About QC, QC Support & QC Raw Materials:
The overall QC organization 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. The vacant position is placed in QC Support which is one out of five departments in our QC Organization: QC Bioassay, QC Chemistry, QC Microbiology, QC Support, and QC Planning & Systems.
In QC Support we are responsible for writing and reviewing customer specific stability protocols and reports, receiving and distributing samples to internal testing teams as well as shipment of samples to customers and external laboratories and lastly but not least we are responsible for test and qualification of raw materials for manufacturing. In QC Support we are in total 31 employees, both scientists and technicians, divided into three groups: QC Samples & Service, QC Stability, and QC Raw Materials.
In QC Raw Materials we are responsible for all raw material specifications. We sample and test raw materials internally as well as use external laboratories. We release materials for production and qualify new Raw Materials when needed. In addition, we engage with internal and external stakeholders in questions and requests related to raw materials. As a Sr. Manager for the QC Raw Materials team you will be the direct leader for 12 skilled colleagues, represented by 7 scientists and 5 technicians in total.
Role & Responsibilities:
You will be leading a team which has expert knowledge of raw material qualification. By stepping into this leadership role, you will be overseeing the implementation of new raw materials to support new projects and commercial projects. There is a great team spirit, and the team members are driven by the changing manufacturing pace, always keeping high focus on delivering on time and at the right quality. As a person you approach leadership and team members with respect, openness, and positive energy. Your responsibilities include but are not limited to:
- Coach, develop and inspire team members
- Ensure a smooth and respectful collaboration with stakeholders across functions
- Ensure all activities are in compliance with cGMP and 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
Your profile:
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
- Has a quality and structured mindset
- Good communication skills and the ability to effectively communicate with all stakeholders
- Strong decision maker 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 trust and psychological safety in the team
- English skills, fluent spoken and written
Your Application:
For further information regarding the position, please contact Director of QC Support, Sanne Bové Dehn, 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.
Top Skills
What We Do
AGC Biologics offers deep industry expertise and uniquely customized services for the scale-up and cGMP manufacture of protein-based therapeutics (using mammalian and microbial systems), mRNA, pDNA, viral vector and cell therapy products, from pre-clinical to commercial production, including our proprietary CHEF1TM Expression System for efficient protein production with CHO cells.
Our company DNA drives us to provide innovative solutions to partner with our customers in helping them reach their goals and accelerate their projects at our cGMP-compliant facilities in the US, Europe and Japan, as well as to facilitate approval and manage spending during the product lifecycle.
We forge exceptionally strong partnerships with our customers and we never lose sight of our commitment to deliver reliable and compliant drug substance.
Visit www.agcbio.com to learn more.
