Process Validation Scientist

  • Job reference
    4290427268

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 Job 

AGC 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 Department

You 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.

 

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Your Profile

In 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   

 

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AGC Offers

AGC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a contract manufacturing organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way, and you will to a large extend be able to plan your daily work yourself. AGC offers an informal working environment, where humor is part of the daily work life. We respect each other and our individual differences. AGC’s employees have a flexible attitude and we help each other to reach deadlines together as one team. 

We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidates are found, the add will close. We are therefore looking forward to receive your application today! AGC Biologiscs is partnering with Adecco on this recruitment, so if you have any questions about the position, you can contact our recruitment team: 

Line Sophie Heyn: +45 3838 1211
Christina Drejet: + 45 3838 7007​


About AGC Biologics
AGC Biologics (AGC) is a global Contract Manufacturing Organization (CMO) with biomanufacturing facilities in Europe, Japan 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.
AGC Biologics also offers non-exclusive license to CHEF1™, a proprietary CHO cell line development platform. CHEF1 delivers stable, high-titer, production-quality cell lines in optimized time frames. It is the foundation of CMC Biologics’ innovative approach to cell line and process development.
Visit www.agcbio.com to learn why AGC Biologics is a World Leader in process development and contract manufacturing. 

 

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Om AGC Biologics

Kontaktoplysninger
Recruitment Team
+45 3838 1211 / +45 3838 7007