Manager for Quality Control, Microbiology
Can you successfully lead a team of QC professionals during times of change and new opportunities? We invite you to join a global pharma company with a strong local presence and an exciting future.
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).
Being a manager in a CDMO give you an opportunity to combine your technical leadership skills in a pharmaceutical company. You will be using your managerial skills when working with very dedicated professionals, as well as using your capabilities as project manager – keeping track of KPI deliveries within own team, and having overview of all new projects that cross your responsibility area. You will be part of a world-class GMP manufacturing facility, and a leading CDMO where we advance tomorrow’s medicines today.
About the Department and the Management Team
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. We work in a busy and dynamic environment where we support the biologics Drug Substance (DS) production as well as the global release of commercial products (DS/DP) for our 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.
About the Job
You will manage the QC Microbiology team consisting of 10 dedicated employees. 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 teams deliveries plays 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 teams 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. FDBD is often inspected by authorities, and therefore part of the daily business is assuring the right level of GMP in the department.
In your daily activity you will have to show great diversity, flexibility and be able to be on top of many different activities showing the direction and prioritisation for the team. As CDMO new products will be on boarded at the production lines. Together with your team, you will evaluate if new product launches calls for creation of new processes to meet GMP requirements.
You will monitor team KPI’s on close basis through board- and video meetings. Your focus will be on delivering on the goals in a safe and healthy working environment, and at the same time assuring that you have an engaged and motivated team.
Qualifications and Education
You have an academic background preferably with analytical focus – primarily within microbiology. You have strong managerial skills with 5+ years of experience within management. 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.
As a person, you can stay focused also during hectic periods and you always approach tasks and colleagues with openness, attitude, energy, humour and provide professional support and guidance to your employees. You have an analytical mind-set, work in a structural way and are used to deliver according to deadlines. 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.
If you can see yourself in this role, then we can offer an exciting and challenging job in a company where there is a very exciting future with many partners and products – one being production of Covid-19 antibodies in 2021-2023. You will be offered a competitive compensation package that includes pension and a bonus scheme. There is great possibility for personal development and the future is exciting and promising – and we can promise that you will not get bored!
Please apply as soon as possible and latest by 24th of January 2021.
FUJIFILM Diosynth Biotechnologies is a world leading cGMP Contract Development and
Manufacturing Organisation (CDMO) with over 25 years’ experience. As a world leading CDMO we combine technical leadership in cell culture, microbial fermentation and gene therapies with state of the art GMP manufacturing, from our network of four global locations in the USA, UK and DK. We currently employ over 2,000 dedicated staff who have a reputation for excellent customer service, flexibility and responsiveness.
As part of FUJIFILM Diosynth Biotechnologies you will be an active contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment and cultivating a world of opportunity for future generations. We invest in you and what you care about, getting the right work-life balance for your health, your family and your professional growth.
FUJIFILM Diosynth Biotechnologies offers a healthy work environment that promotes individual responsibility, allowing you to grow and progress. We support our employees with programs that motivate and educate, promoting a healthy work-life balance that ultimately increases personal well-being and employee satisfaction.