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. 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.

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

The Job
The Team Lead/Manager Upstream Process Transfer will be responsible for the process transfer upstream team consisting of 7 scientists involved in upstream process transfers from clients or from another AGC site globally into the CPH site. More specifically, the team facilitates the transfer into and from development to the manufacturing area, ensuring the quality/documentation is in place for manufacturing such as gap assessments, process instructions, raw material assessments, disposable specifications, sample plans, process reports, and change requests and so on. In addition, the team is involved in late stage activities, such as FMEA, process risk assessments, PPQ documentation etc.

The candidate will manage and delegate project related activities focused on upstream process transfer, through interaction with scientific and technical staff. This role requires proven scientific and technical skills as in the field of bioprocessing, including leadership skills or leadership potential working with a team of scientists (all M.Sc. and/or Ph.D. level). The Team Lead/Manager will work closely with and oversee day-to-day activities of scientific staff and report directly to the department director of process transfer. The candidate 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.

Key responsibilities:

  • Manage the day-to-day operations in the team – ability to balance workload over several projects simultaneously and delegate accordingly
  • 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
  • Provide 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 
  • Support requests for technical assistance from the rest of the AGC biologics organization globally – ensuring seamless cross-organizational interactions
  • Interface with internal and external stakeholders and represent the department and the team effectively and professionally
  • Engage in preparation of proposals for planning of new projects

The position offers a great deal of dynamics being involved in all types of microbial and mammalian biopharmaceutical processing and requires interaction with a large number of stakeholders. The position is unique in having contact with both our customers and all internal departments. 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 16 highly skilled scientists, 2 team leads/managers (one is the current vacancy), one director, and student helpers. The department is divided into two teams, one for upstream process transfer and one for downstream process transfer, respectively. We have an open communication and strong support and flexibility within the department.
 
Your profile
Our ideal new colleague will have the following experiences:
  • Degree in science, engineering, or a related field (M.Sc. or Ph.D.).
  • Extensive experience and knowledge in upstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting, but preferably both.
  • Leadership experience as a manager or leadership potential.
  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.
  • Experience in biopharmaceutical late stage projects.
  • Familiar with EMA, FDA, and ICH regulations for manufacturing of biologics.
  • The company language is English, so excellent English communication skills is 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. 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.

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 add will close. We are therefore looking forward to receive your application today!

For further information, please contact Kristian Becker, Director Process Transfer, kbe@agc.com

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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.

 

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