PK/ADA Bioassay Coordinator
Clinical Development - Lund
At BioInvent, we are experts in the field of antibodies for the treatment of cancer and we strive for developing first-in-class or best-in-class immuno-modulatory agents with the potential to dramatically change the quality of life of those patients living with the disease. In our biotech company we are approximately 70 employees and we are covering all parts for drug development, including discovery, preclinical research, manufacturing and clinical development. Together we all contribute to the success of BioInvent and we welcome you to be part of it - as a PK/ADA Bioassay Coordinator.
As a PK/ADA Bioassay Coordinator you will be part of our positive and engaging clinical development team. You will be responsible for identifying, developing, and performing robust, reproducible biological assays (e.g. PK, PD and ADA assays) to support drug development in a team environment. You are responsible for tech transfer of assays, both to BioInvent and from BioInvent to contract research organizations (CROs) and other collaborators.
In selected programs, you are the 1st point of contact to BioInvent's analytical CROs and other potential collaborators. You work closely with the Clinical Development team in the immunoassay data-transfer from Central Lab to subsequent pharmacokinetic analysis and you handle the contractual questions with collaborators and take part in audits as needed. Documentation, information and communication both internally and externally is a great part of your responsibility and you also have to reassure that assignments and tasks are performed in line with the quality manual, project handbook and relevant SOPs and methods. You should be familiar with Good Laboratory Practice and Good Clinical Practice and also have an interest to overview the technology development within the immunoassay area to develop, propose and implement strategies to update BioInvent's technology and competence within the PK and immunogenicity field.
You have PhD in Pharmacy, or related field of analytical chemistry and at least 3 years of experience from research activity within academy and/or pharmaceutical development. You are proficient in written and spoken English.
Preferably you have experience from planning and evaluating sample collection and analysis for pre-clinical and clinical studies, in accordance with relevant guidelines and regulations. You have a good understanding of analytical questions and ability to contribute with competence and troubleshooting within the area of protein chemistry and analytical science. A strong background in experimental curve-fitting, statistics, and assay optimization and execution is required. Finally, understanding of PK/PD concepts and modelling is important.
Skills and Capabilities
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. Personal suitability is of great importance and we believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines and to secure high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your team.
To summarize, we have several value driving factors in place with great potential for the future. If you match our requirements and would like to contribute to important cancer research as a part of BioInvent and our exciting future, you are welcome to apply for the position!
Please send your application (CV and personal letter). 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 2020-02-26.
BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen & Jenny Nilsson, Unionenklubben