A challenging and varied job in our Process Validation Department in Copenhagen as Team Lead Process Validation is open for a quality-minded new colleague with biopharmaceutical processing experience and a strong ability to drive interdepartmental collaboration.
 
The Role
The role of Team Lead Process Validation offers the opportunity to manage up to 6 scientists involved as SMEs and in risk assessments that support process validation projects from clients or from another AGC site globally into the CPH site. More specifically, the team manages all the 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; change requests and so on.

The candidate will manage and delegate project-related activities focused on process validation, through interaction with scientific and technical staff. This role requires proven experience in the validation of processes (process design, process performance qualification and continued process verification), scientific and technical skills 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 will work closely with and oversee day-to-day activities of scientific staff and will report directly to the department Director of Process Validation. The candidate must create a positive, motivating and productive working climate in accordance with AGC Biologics values. The incumbent 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 as needed.
  • Contribute towards developing the overall PV 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 concerning validation-related issues, to internal and external stakeholders.
  • 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.
  • Review and update technical documentation as required (e.g. plans, reports, SOPs).
  • Review proposals for new projects incoming to AGC Biologics.

The position offers a dynamic environment with plenty of learning opportunities in the field of process validation as well as all types of microbial and mammalian biopharmaceutical processing.

The role 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 Validation department currently consists of 14 highly skilled scientists, one director, and student helpers. The department comprises SMEs in management of PV activities, supporting studies (including risk assessments and mix and hold validation studies) as well as 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 experience:
  • Degree in science, engineering, or a related field (M.Sc. or Ph.D.).
  • Proven track record within the field of Process Validation.
  • Leadership experience as a manager or leadership potential.
  • Excellent mentorship skills.
  • Ability to think creatively and solution-driven.
  • Strong technical writing skills.
  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize between many different tasks.
  • Experience and knowledge in upstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting, is desirable.
  • 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 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.

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