Team Leader in GMP Manufacturing

At BioInvent we are experts on antibodies and cancer immunology. We strive to develop first-in-class immuno-modulatory antibody-based - treatments that have significant potential to improve cancer outcome and cancer patients’ quality of life. We are based in Lund in Sweden and amongst our 70+ employees cover all parts for drug development including preclinical research, manufacturing and clinical trials.
Together we are creating an exciting future for BioInvent and we welcome you to be part of this journey as our Team Leader in GMP Manufacturing
We are seeking a Team Leader with hands-on experience with manufacturing of antibodies. BioInvent’s manufacturing facility do produce material for drug development and are approve for production of phase I to III material. Our manufacturing is part of the drug development and do support BioInvent’s development of antibodies for use in clinical trials for treatment of cancer patients. We do also support external customers in their drug development programs and BioInvent’s international partners.
For each product we do produce a small number of batches which means that you and your team must be able to handle and react on a variety of process challenges.
You will lead a team of approx. 10 highly educated employees. The team is part of the Manufacturing group which is in the Division of Technical Operations responsible for all CMC related activities including process development, manufacturing, QC and QA. We generate cell lines, develop processes and supply BioInvent’s clinical projects with antibodies, and additionally serve external customers as a CMO. At BioInvent we mainly use CHO cells for production and cultivate cells in single use bioreactors in sizes up to 1000L.
Your primary task will be to coordinate and lead the daily work in GMP Manufacturing and to actively participate in the production process.
You will need to prioritize between competing tasks and have a close collaboration with other leaders in the matrix organization. In addition, you will also interact with our pre-clinical and clinical departments and take in task such as IND/IMP applications.
Key Responsibilities
Coordinate and lead the daily tasks in GMP Manufacturing
Troubleshoot and resolve unexpected events
Identify, recommend and implement improvements related to routine functions
Share your expertise and be able to train, motivate and develop team members
Continuously work with optimization and LEAN
Interact with customers and service providers
Draft and revise documents such as SOPs and methods
Conduct investigations and write deviations, CAPAs and Change Controls
Support preparing regulatory submissions
Participate in audits

Requirements
Experience and Qualifications
Minimum 3 years experience of leading a team of highly qualified team members
Comprehensive knowledge of cGMP, minimum 5 years of GMP experience
Experience with cell cultivation and protein purification is required
Good computer skills, experience with electronic document handling systems (knowing Veeva is an advantage)
Documented ability to work across multiple projects in parallel
Experience in customer relations and project planning
Fluent in written and spoken English. Understanding Swedish is an advantage

Skills and Capabilities
You are a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem-solving skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Your attitude and personality are of great importance - you are thorough yet efficient and strongly committed to making things happen. You understand the importance of achieving results, being flexible and adjusting to our processes, keeping deadlines and securing the highest quality of your work. You are enthusiastic and enjoy generating results and achieving goals both individually and jointly with your team.
If you match above described profile and are excited to contribute to BioInvent’s important cancer research journey, we welcome you to apply for this position.


Other information
The position is a full-time position based in Lund, Sweden. The working hours are mainly day-time and flex hours, but the position will to some extent also include support outside office hours and during weekends.
You will report to Director of Manufacturing.


Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Selection is on-going and interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 2021-04-25


BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben