Process Validation Manager

  • Job reference
    4283751668

We are looking for an experience person with biopharmaceutical process validation and leadership experience with a strong ability to drive interdepartmental collaboration to participate to the growth of our Process Transfer Department in Copenhagen as Manager/Senior Manager Process Validation.

 


The mission

AGC Biologics continues to enjoy great success, with a steadily increasing number of customers and projects – many of which are late stage development biological projects preparing for commercial launch. At the same time, we are handling many new and exciting customer projects and give support to processes already running in our facility for clinical and commercial supply. We are now hiring a manager/senior manager to lead the process validation team.
The Process Transfer department is divided into three teams (upstream process transfer, downstream process transfer and process validation), each with 6 scientists. We are now recruiting a manager/senior manager for the validation team.
​The manager/senior manager will be responsible for leading the process validation activities at AGC Biologics Copenhagen and guiding the 6 professionals, providing coordination of all process validation related activities including preparation and finalization of all documentation associated with process validation according to authority guideline principles.

The manager/senior manager will direct the day-to-day project related activities focused on process validation. This role requires proven scientific and technical skills as a professional in the field of process validation, including leadership skills working with a team of professionals. The manager will work closely with and oversee activities of scientific staff and report directly to the department Director of Process Transfer. The manager must create a positive, motivating and productive working climate in accordance with AGC Biologics values. The candidate will also be responsible for cross-organizational activities associated with the Manufacturing, Quality, and Development organization and setup the strategy for process validation of several late stage biopharmaceutical programs.

The position offer interaction with a large number of stakeholders, and is unique in having contact with both our customers and all internal departments involved in process development and manufacturing. You will be introduced to biopharmaceutical companies globally and be an active player in their projects.  

 

   

Key responsibilities

  • Setup the strategy and coordinate activities related to biopharmaceutical process validation.
  • Monitor team member’s participation, engagement, and performance to ensure individual performance in the team setting.
  • Communicate clear instructions and feedback to team members and listen to team members' feedback.
  • Facilitate and or provide training for team members on a as needed basis.
  • Develop team strategy to reach team and department goals.
  • Comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards.
  • Manage the flow of day-to-day operations in the team – ability to balance workload over several projects simultaneously .
  • Provide innovative solutions to complex problems surrounding the Development and Manufacturing processes - Provide scientific support to Manufacturing on e.g. investigations and provide required documentation.
  • Support requests for technical assistance from the rest of the AGC biologics organization globally – ensuring seamless cross-organizational interactions Interfaces with internal and external stakeholders and represents the department and team effectively and professionally.
  • Report and update the team´s progress to department manager.
  • Design test plans and or protocols, create technical reports and presentations.
  • Assist Head of department in department and scientific efforts as needed.​

Uddannelsesniveau
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Your profile

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

  • Degree in science, engineering, or a related field (at least MSc. or PhD level).
  • 5-10 years relevant experience and understanding of process validation of biopharmaceuticals.
  • Leadership experience or strong leadership potential.
  • Excellent English communication skills
  • Ability to effectively communicate with others engaging with customers and colleges of various cultural background, with an ability to obtain buy-in from all key stakeholders
  • Knowledge of EMA, FDA, and ICH regulations for biologics
  • Quality by Design methodology knowhow is a plus
  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.

 

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AGC Biologics 

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 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, in accordance with our slogan - Right. On Time.

 

How to apply:

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 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. 

Andre oplysninger
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Om AGC Biologics

Kontaktoplysninger
Line Heyn
+45 3838 1211 / +45 2568 3527