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Process Validation Scientist

A stimulating job in our Process Validation Team, Process Transfer Department in Copenhagen as a process validation scientist is open for a quality-minded new colleague with biopharmaceutical processing experience.The JobAGC Biologics continues to enjoy great success, with a steadily increasing number of projects – many of which are late stage development projects preparing for commercial launch. More specifically, we have several projects active in the process validation stages from initial process risk assessment to execution of PPQ runs. At the same time, we are still handling many new and exciting customer projects and give support to processes already running in our facility for clinical and commercial supply. With AGC Biologics increasing activities, we are looking for new colleagues in supporting validation activities in manufacturing of various biopharmaceuticals.The Process Validation Scientist is responsible for designing validation risk assessments, validation plans and protocols, supporting execution of validation studies, compiling data and completing validation reports for late stage / commercial manufacturing validation.Key responsibilities:

  •  Responsible for relevant validation activities according project plan (from process design through commercial production)
  • Oversight the activity from planning, execution, to completion (establish scientific evidence of consistent process performance and product quality via main and supportive validation studies)
  • Author risk assessments, plans, protocols, reports and related validation deviations

The position offer interaction with key stakeholders both internally and externally. You will be introduced to global biopharmaceutical companies and be an active core team member in their projects.  The DepartmentYou will be a part of the process validation team headed by the process validation manager, as part of the Process Transfer department. We have an open communication and strong support and flexibility within the department.The department is responsible for transfer of processes from customers to AGC Biologics and between development and manufacturing internally, as well as between AGC manufacturing sites globally (Denmark, United States, Germany, and Japan). Furthermore, the department is responsible for, and coordinates, process risk assessment and process validation activities. The department is recognized as a group of process subject matter experts and very often provides input in meetings with potential new customers and audits. Additionally, the department is involved in inspections with both domestic and foreign authorities.Your profileIn our new colleague, we are looking for a person with:

  • Quality mindset and experience in process validation of biopharmaceuticals
  •  Degree in science, engineering, or a related field (MSc./Ph.D)
  • Ability to effectively communicate with costumers and internal colleges
  • Understanding of authority and regulatory guidelines associated with biopharmaceutical production and process validation 
  • Excellent English skills
  • Driven, open-minded and result-orientated attitude and ability to collaborate with different stakeholders   

AGC Biologics CopenhagenAGC Biologics offers a dynamic working place and an excellent opportunity for working and growing with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a biologics contract development and manufacturing organization interact in order to achieve success. Exciting and challenging assignments will keep coming your way, but you will to a large extent be able to plan your daily work on your own. AGC Biologics offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC employees have a flexible attitude and we help each other to reach deadlines together as one team, in accordance with our slogan - Right. On Time.  Application We continuously evaluate incoming applications and conduct interviews accordingly. Therefore, please submit your application and CV as soon as possible. When the right candidate are found, the ad will close. Want to keep posted about our growth and to learn more about our company?We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !  AGC Biologics (AGC) is a global Contract Development Manufacturing Organization (CDMO) with bio-manufacturing facilities in Europe, Japan, Italy and the USA. The company provides a comprehensive range of commercial and clinical cGMP biologics manufacturing services, from DNA to active pharmaceutical ingredient (API). The company’s team and approach are tailored to each of its client’s needs, whether turnkey manufacturing or sophisticated, stand-alone analytical, formulation and stability services. Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing.


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