AGC Biologics | Principal Scientist for Process Validation

A stimulating job in our MSAT Process Validation Team, in Copenhagen as an experienced, experienced Process Validation Specialist (Principal 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, as well as launched projects. 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 biopharmaceuticals.

The Process Validation Specialist is responsible for leading process validation activities which include; designing validation plans and protocols, compiling data and completing validation reports for late stage / commercial manufacturing validation and cross-functional coordination to ensure task delivery.

Key responsibilities:

• Responsible for leading process validation activities
• Manage process validation activities: planning, execution and completion stages
• Facilitates technical discussions with internal and external stakeholders
• Author and review plans, protocols and reports
• Raises and solves complex tasks and challenges
• Experienced in deviation management, CAPA implementation
• Supporting projects post-PPQ towards commercialization
• Identify and implement improvement programs as required

The position offers interaction with different stakeholders both internally and externally. You will be introduced to biopharmaceutical companies globally and be an active player in their projects. 

The Department

You will be a part of the Process Validation department (MSAT). We have an open communication and strong support and flexibility within the department.

The department is responsible for the validation of late stage processes from our Customers, prior to commercialization. We work very closely with our other MSAT colleagues including  Process Transfer and Manufacturing Science, as well as other functions such as Process Development.

Furthermore, the department is responsible for, and coordinates, process risk assessment, mix and hold validation studies,  establishes and maintains CPV programs. The department is recognized as a group of process subject matter experts and often provides input in meetings with potential new customers and audits. The department are furthermore involved with inspections with both national and global authorities.

AGC Biologics Copenhagen

AGC 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.

We will process the applications in the order they arrive. Therefore, please submit your application as soon as possible. When the right candidate is found, the advert will close. 

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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.

Your profile

In our new colleague, we are looking for a person with:

• At least a MSc in science, engineering, or a related field
• Considerable experience of process validation within biopharmaceutical production (5-8years)
• Good English, both written and verbal. Demonstrated ability in writing technical protocols and reports
• Good team player, be open mind and result-orientated
• Ability to effectively communicate with customers and internal colleges
• Proven mentoring skills
• Experience in protein chemistry, CMC, process development, process transfer or manufacturing is desirable