QC Microbiology Manager
Can you successfully lead a team of QC professionals during times of change and new opportunities? On behalf of our client, Fujifilm Diosynth Biotechnologies, we invite you to join a global pharma company with a strong local presence and an exciting future.
Be part of a successful organisation
You are offered an exciting and challenging job in a company with a very exciting future with many partners and products - one being production of Covid-19 antibodies in 2021-2023.
We are looking for a QC Microbiology Manager with proven people manager- and change management capabilities. As QC Manager, you will have a vital role in a very exciting time for the organization as the branch in Hillerød currently is in the process of expanding Drug Product (DP), expanding the Drug Substance (DS) and Finished Goods (FG) capabilities as a Contract Development and Manufacturing Organization (CDMO).
Team QC
QC Hillerød consists of approximately 90 employees divided into five testing groups such as QC Microbiology, QC Bioassay, QC Raw materials, QC Chemistry etc. and various support teams. The team supports the biologics Drug Substance (DS) production as well as the global release of commercial products (DS/DP) for clients from all over the world.
As Manager for QC Microbiology, you will work closely with the other QC Managers and with the support teams.
The QC management team values are honesty, openness, respect and collaboration. The management team meets every week to discuss status on on-going projects, cross-functional activities, workload, strategy and to solve challenges together. You will also work closely together with the Senior Manager and QC Director in order to secure that you reach your KPI’s. You will get to work with many both new- and existing partners and products in an organization that also prioritize your professional and personal development.
More about the job
You will manage the QC Microbiology team consisting of 9 dedicated colleagues. The primary daily deliveries in the team is testing of release, in-process, UM/EM samples and stability samples of our commercial products (DS/DP) using various compendia methods (Bioburden, endotoxin, CCI, ID of species etc). The team deliveries play an important role as part of the DSM production and facility – especially around the microbial control strategy during DSM production, but also in case there are excursions or investigations that require microbial support.
The team works 7 days a week on normal working hours to support fast turnaround time of Bioburden samples that needs to be analysed within 24 hrs. Fujifilm Diosynth Biotechnologies is often inspected by authorities, and therefore part of the daily business is assuring the right level of GMP in the department.
Your background
You have an academic background preferably with analytical focus - primarily within microbiology. You have strong managerial skills. You have previous experience in working within a GMP environment and have a strong mind-set for quality and compliance. Having knowledge of sterility testing and fill finish is an advantage. But above all, we are looking to find a strong people manager that lead by example and enjoys developing both the individual and the team as a group.
At a personal level you are a good communicator, also in English, who understands the importance of involving employees and stakeholders. You possess a positive mind-set and are not afraid of making difficult decisions.