Team Leader and Senior Scientist – Process Transfer/Manufacturing Sciences

Team Leader and Senior Scientist – Process Transfer/Manufacturing Sciences

A challenging and varied job in our Process Transfer Department in Copenhagen as a technical expert and Team leader is open for a quality-minded new colleague with biopharmaceutical processing experience and a strong ability to drive interdepartmental collaboration.

The Job

AGC Biologics continues to enjoy great success, with a steadily increasing number of customers and projects – many of which are late stage development 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. With AGC Biologics increasing activities, we are looking for a new colleague with biopharmaceuticals manufacturing sciences experience and preferably leadership experience.

The team leader is responsible for the combined upstream and downstream team consisting of nine professionals involved in process transfer from customers and from site to sites within AGC globally (US, GE, JP and DK). More specifically, the team facilitates the transfer into and from development to the manufacturing area, ensuring the quality/documentation is in place for manufacturing according to customer and regulatory expectations. The candidate will also be assigned to a minor part of the project portfolio while managing the team of SME’s.

Moreover, the Team Leader will direct the day-to-day line and project related activities focused on Process Transfer and Manufacturing Scientific Support, through interaction with scientific and technical staff while gathering, analyzing, and interpreting development and manufacturing data as well as compiling the required documentation. Progress, goals and milestones shall be communicated through verbal or written reports and presentations internally and to the rest of the AGC organization. This role requires proven scientific and technical skills as a professional in the field of manufacturing sciences, including leadership working with a team of professionals (all M.Sc. and or PhD level). The Team leader/Senior Scientist will work closely with and oversee day-to-day activities of scientific staff and report directly to the department Director of Process Transfer. The team leader must create a positive, motivating and productive working climate in accordance with AGC Biologics values. Additionally she/he must conduct employee performance appraisals and set goals. Additionally, the candidate is responsible for cross-organizational activities associated with the Manufacturing, Quality, and Development organization through the role as team leader, by conveying and reporting result of relevance from the department to stake holders.

Key responsibilities:

• Team Leader - Functions in a team setting efficiently with other team members and team lead peers within Process Transfer
  
  
• 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
  
  
• Provides innovative solutions to complex problems surrounding the Development and Manufacturing processes - Provide scientific support to Manufacturing on e.g. investigations and provide required documentation for operations in the manufacturing area
  
  
• Supports 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
  
  
• Engages in preparation of proposals for planning of new projects including the acquirement of novel technology platforms
  
  
• Reports and updates to department manager on the team's progress
  
  
• Designs test plans and or protocols, creates technical reports and presentations and completes tasks delegated by head of department - Assists Head of department in department and scientific efforts as needed
  
  

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. The daily challenges will vary a lot, and two days will never be the same.

The Department

The Process Transfer department currently consists of 15 highly skilled scientists, 2 assistants, 1 team lead (the vacant position), 1 manager and 1 Director. The department is divided in sub teams corresponding to process validation governance and upstream/downstream process transfer. You will be a part of the process transfer management team headed by the department Director. 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, audits and inspections with both global and national authorities.

Your profile

In our new colleague we’re looking for a person with:

• Degree in science, engineering, or a related field (MSc. or PhD)
  
  
• Experience with manufacturing sciences in biopharmaceutical production
  
  
  • 7+ year experience in a regulated (cGMP) manufacturing environment
    
    
  • 2+ years experience with Phase III or Commercial products
    
    
  • Preferably 1+ year as 1st line manager
    
    
  
  
• Good English communication and 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
  
  
• Familiar with EMA, FDA, and ICH regulations for biologics
  
  
• Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks
  
  

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.

For further information please contact Henrik Næsted, Director of Process Transfer, [email protected] or Thomas Sandal Vice president of Development, Thomas Sandal [email protected]

We will process the applications in the order they arrive. Therefore, please submit your application and CV as soon as possible.

................................................................................................................................................................................................................

AGC Biologics is a leading global Contract Development and Manufacturing Organization, with a deep commitment to improving life quality by bringing new biopharmaceuticals to market. Because of our dedication to building and empowering our internal teams, AGC Biologics is an innovative leader in the industry with an extensive network of cGMP facilities in the US, Europe and Asia. As such, we deliver a deep expertise, dynamic solutions and technologies, as well as customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. We forge exceptionally strong partnerships with our clients, and we never lose sight of our pledge to deliver a reliable and compliant drug substance supply. Right. On time. For more information, visit www.agcbio.com.