Copenhagen, Denmark

Job Summary
AGC is looking for temporary (18 months) scientist within the Process Validation Department in Copenhagen, which requires process validation knowledge and a strong ability to drive interdepartmental collaboration.

The role of Process Validation Scientist offers opportunity to lead, coordinate and oversee process validation activities for late stage projects from initiation to completion. The Process Validation Scientist will be responsible for providing technical input to internal and external stakeholders as required throughout the process validation lifecycle. This includes activities required for process validation including the documentation (plans, protocols and reports); risk assessment (e.g. FMEA); mix and hold validation studies, monitoring and trending of data.

Key responsibilities:

• Plan, organize and execute process validation activities for drug substance manufacturing (e.g., mixing and hold validation, continued process verification).
• Generate process validation plans, protocols and reports in a timely manner and according to project requirements.
• Use scientific knowledge to analyze and interpret data, propose next steps and actions required. Take timely and appropriate action based on the data output.
• Interface with internal and external stakeholders and represent the department and the team effectively and professionally.
• Communicate and present findings at meetings as required.
• Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards.

The Department
The Process Validation department currently consists of 10 highly skilled scientists, 1 director, 3 managers and a student assistant. The department comprises Subject Matter Experts (SMEs) in management of PV activities, supporting studies (including risk assessments and mix and hold validation studies) as well as Continued Process Verification (CPV) monitoring. We have an open communication and strong support and flexibility within the department.

Your profile
Our ideal new colleague will have the following:

• Degree in biological science, engineering, or a related field (minimum M.Sc.).
• relevant experience in process validation within biopharmaceutical production and GMP is a plus
• Strong technical writing and presentation skills.
• Familiar with EMA, FDA, and ICH guidelines for process validation.
• Experience and knowledge in upstream and downstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting, is desirable.
• A fast learner with a positive mindset and drive.
• The company language is English, so excellent written and spoken English communication skills are required.

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. You will largely 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.

We will process the candidates as they arrive. Therefore, please submit your application and CV as soon as possible. When the right candidate is found, the advert will close. We are therefore looking forward to receive your application today.

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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.