Together into the future CSL Behring is a global biotherapeutics leader which is driven by its promise to save lives. With over 1,400 employees we develop and manufacture plasma-
derived therapies at our facilities in Bern to deliver them to patients worldwide. For our location in Bern, we are looking for an Associate Director Plasma Product Development In this exciting and responsible position, you will be managing and guiding a team of scientists and technicians tasked with the development and optimization of processes for the manufacturing of plasma-
one plasma process development group and another team responsible for statistics, technical writing, knowledge management and risk management (supporting all of Bern PD&I in these critical functions).
Providing technical expertise and leadership to the assigned team members. Ensuring and supervising scale-up, technology transfer and facility fit assessment of development to commercial manufacturing processes.
Motivating, training and developing all staff. Hiring and developing talents in line with CSL’s strategic objectives is another important element of this position.
Generating, reviewing and approving technical reports and regulatory documents for health authority submissions; working closely with CMC Team to ensure that source documentation from Bern PPD is aligned with Quality by Design expectations and submission-
ready. Serving as CMC representative for health authority and partnering interactions. In addition, you will be responsible for working with senior leadership teams to maintain an environment that fosters team work, collaboration and innovation in addition to transparent and timely communication with others internally (up, down and laterally) and externally.
Go for it - the following competencies will help you to be successful in this role : An academic scientific qualification, e.
g. Master of Science or Doctorate in Biochemistry or related area with more than 5 years of industrial experience in process development.
Strong and proven scientific background in protein sciences. Demonstrated ability in managing highly effective teams. Experience in working in cross-
functional, multicultural and international teams. Experience in project work and excellent communication and analytical skills.
Strong planning and organizational skills. Strong working knowledge of ICH Q8 11 and other regulatory guidance documentation around quality risk management, Quality by Design and knowledge management.
Generation of technical assessments and documents for submission to regulatory agencies. Proven managerial experience within project oriented, multidisciplinary and multicultural environments.
Excellent written and spoken language skills in English and German Worker Type : Employee Worker Sub Type : Regular