Project management for Influenza Vaccine development at Abbott Biologicals

While completing my assignment at Abbott Biologicals in Weesp, the head of my department indicated that she had found a sparring partner in me. I really appreciate that feedback because I see good collaboration as the key to a successful and pleasurable project.

Last December, I finished my challenging assignment for Janssen Vaccines as Process Engineer working on the product development of the Covid vaccine. I was enthusiastic about one of the new opportunities for the next step. I did an online interview for an interim project manager position at the Competence Center Influenza of Abbott Biologicals. From the first moment, I felt we had a connection and it was the right job for me. They hired me right away.

My assignment included two product development projects for the influenza vaccine:

  1. Project management and eCTD technical writing for preparation of dossier submission to the authorities related to vial filling in addition to the registered production of pre-filled syringes of the vaccine.
  2. Project management support for technology transfer and preparation of dossier submission to the authorities related to the production of pre-filled syringes of the vaccine at a contract manufacturing organization (CMO) abroad.

The currently registered influenza vaccine production process consists of the final bulk production at Abbott Biologicals in Weesp, followed by transfer of the bulk to Abbott Biologicals in Olst to manufacture the final lot in pre-filled syringes. The vaccine is produced seasonally based on the recommendations from the World Health Organization for the concerned hemisphere.

For the first project, three final bulk batches were selected to produce three final lot validation batches of the vaccine filled in vials. The main aim was to structure the project goals, organize regular meetings with the various stakeholders from both locations, monitor the planning, material transfer en testing, and effectively manage project progress and deliverables. In consultation with Regulatory Affairs and subject matter experts, I wrote technical documents describing the manufacturing of final lot in vials and managed the document review and approval flow.

For the second project, I designed a process map to clarify the manufacturing process from the final bulk to the final lot, including transport conditions and requirements of the materials between the different locations. The process map provided a clear insight into the current registered process and the future process of filling and packaging the vaccine at the CMO. The Process Map was discussed during Brown Paper sessions and helped the Technology Transfer team identify gaps and formulate team actions and Change Tasks for the Change.

The role of project manager is different in every organization. During these projects, I noticed that you first have to get to know the structure and culture of an organization before you can more effectively determine the work, time schedule, meeting structure and roles and responsibilities. I am used to coming up with solutions immediately. I learned to be more patient. As the head of my department said to me, “Not everything can be solved by you, sometimes it is good to let it happen.” It made me realize that in certain cases it is better not to think about how to handle a problem until after a meeting.

The most exciting part of my assignment was working with different disciplines within the projects and making sure everyone is working towards the same goal. Each department looks through a particular lens (Quality Assurance, Regulatory Affairs, Manufacturing, etc.). Sometimes I had to convince parties why and how certain information is needed by the authorities. It was inspiring to learn from each other and work together on improvements.

My structured way of working helped me to achieve my project goals completely and in a timely manner and was also appreciated by colleagues. The validation batches were successfully produced and tested and a significant portion of the eCTD documentation had already been approved before my departure, well before the dossier had to be submitted.

Moreover, I am very happy that the customer has implemented my process map to monitor the new commercial process. It is always satisfying to leave a sustainable resource for the customer and to face a new assignment with confidence after such a valuable experience.