*Manager, Process Validation (MSAT)

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An opportunity has arisen within the Process Validation Department (within the MSAT Organization) at AGC’s Copenhagen site. We are looking for an experienced Manager in Process Validation to manage a team responsible for the execution of the validation programs, and to shape the strategy and direction of the Process Validation (PV) Department.

The Role

The role of Manager, Process Validation offers the opportunity to manage a team of 6 scientists whose responsibilities include: driving the validation activities of a project, conducting process validation-related activities such as, risk assessments, mixing and hold time validation studies and the establishment and maintenance of continued process verification (CPV) programs. More specifically, the team manages the activities required for process validation including the documentation (plans, protocols and reports).

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 bioprocesses (process design, process performance qualification and continued process verification), scientific and technical skills in the field of bioprocessing, as well as leadership skills or leadership potential working with a team of scientists (all M.Sc. and/or Ph.D. level). The Manager 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 is responsible for all people management tasks, such as: recruitment, onboarding, employee performance appraisals, development, coaching and feedback, goals setting and goals review, change management and offboarding.

Key responsibilities:

  • Manage the day-to-day operations in the team – ability to help the team balance workload over several projects simultaneously and delegate accordingly.
  • Communicate clear instructions and goals, provide timely 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 and KPIs (e.g., quality and project KPIs)
  • 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 (e.g., during regulatory inspections, client site visits, etc.).
  • Review and update technical documentation as required (e.g., plans, reports, SOPs).
  • Review business proposals for new projects incoming to AGC biologics.
  • Participate in the hiring strategy for the department.

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 several stakeholders. The position is unique in having contact with both our customers and most 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 13 highly skilled scientists, two managers, one director, and student helpers. The department comprises of SMEs who manage project-related PV activities, such as risk assessments, mixing and hold time validations and CPV monitoring. We promote a culture of open communication, strong support and flexibility within the department.

Your profile

Our ideal new colleague will have the following experiences/behaviors:

  • Degree in biological sciences, engineering, or a related field (M.Sc. or Ph.D.).
  • Proven track record specifically within the field of Process Validation (5 years) plus a minimum of 2 years leadership experience as people manager/leader or leadership potential.
  • Excellent mentorship skills, capable of empowering employees and following-up on their development and progress.
  • Setting the directions to the team, assessing, and improving employee’s performance through continuous feedback/feedforward.
  • Collaborating with the management team to set strategies, use multiple criteria decision analysis, data and KPIs in decision-making processes, manage changes, create, and foster team spirit and trust within the department.
  • Ability to think creatively and solution driven.
  • Strong driver of interdepartmental tasks with the ability to keep the end goal in mind and prioritize many different tasks.
  • Familiarity in working in a regulated environments (e.g., following GxP) good knowledge and application of cGMP practices, risk management as well as, EMA, FDA, and ICH regulations for the manufacturing and validation of biologics.
  • The company language is English, so excellent English communication and technical writing skills are required.
  • Demonstrated proficiency in Microsoft Office programs.
  • Experience and knowledge in upstream/downstream biopharmaceutical processing (microbial and/or mammalian), either from a development or a manufacturing setting, is desirable.
  • Previous experience in supporting audits and regulatory inspections would be an asset.

Fostering continuous improvement of processes and work-life balance

Want to keep posted about our growth and to learn more about our company?

We also urge you to follow us on our LinkedIn Company Page and give us a quick Like on Facebook !

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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Jobbet er oprettet på vores service den 26.1.2024, men kan have været deaktiveret og genaktiveret igen.

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