Scientist, QC Stability (maternity cover)

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.

Do you believe that great results start with great values
In our QC Stability team we are building more than stability programs - we are building a culture based on trust positivity and a strong desire to learn and improve!

In this 9 months maternity cover you will be fortunate to join a fantastic team where mutual respect and helpfulness shape everyday life - not only within QC Stability but across the entire support organization! Collaboration comes naturally and people genuinely support each other.

We are looking for a solution-oriented colleague who takes ownership and approaches challenges with curiosity. Experience within Stability is a strong advantage but not a requirement. What matters most is your mindset your willingness to learn and your ability to contribute positively to the team.

The QC Department:

You will be part of QC Support where you will join a team of highly dedicated scientists and technicians. QC Support consists of five departments: QC Raw materials QC Samples Service Equipment LIMS and QC Stability. You will be a part of the QC Stability Team which is a part of Quality Control handling stability studies of Drug Substance Drug Product Placebo and Reference Material. Your working day is characterized by ongoing collaborations with stakeholders such as customers project managers management your own department and QA.

Role & Responsibilities:

Along with your team members you will work with the Stability aspects of customer projects including to identify and manage the analytical stability packages needed for the projects. Your responsibilities include:

• Writing and reviewing CR Deviations and CAPA documents
• Writing and reviewing customer specific stability protocols and reports
• Engaging with the customers regarding stability topics
• Overseeing testing at external laboratories
• Ensuring cGMP compliance with relevant guidelines (EU FDA)

Your Profile:

The ideal candidate holds an MSc in Biochemistry Pharmaceutical Sciences or other relevant area and preferably with work experience within quality control or quality addition we expect you to bring some of the following experience and characteristics

• Sound knowledge of stability of DS/DP and cGMP
• Experience handling change controls deviations and CAPAs
• The ability to communicate clearly in English both in speech and writing
• Demonstrated experience in driving continuous improvement and/or productivity programs
• You are a huge team player combined with the ability and desire to work independently

Furthermore you thrive in a challenging and dynamic environment and enjoy a rapid pace of work. You bring a positive can-do attitude and a good sense of humor to the team.

Your Application & Our Interview Process:

Send your application as soon as possible and no later than the 6th of January. We treat the applications as we receive them and conduct interviews with qualified applicants.

We look forward to hearing from you!

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 2500 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.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.