Boehringer Ingelheim
Biberach, Germany
Combine your in-depth knowledge of late stage cell culture development of NBE and Biosimilars with your excellent interpersonal, writing and organizing skills in a responsible position as Senior Associate Director (m/f) NBE and Biosimilars within our Corporate Division Biopharmaceuticals.
Job Profile
- You provide scientific leadership to Cell Culture Development in the late stage development of NBE and Biosimilars processes for the manufacture of therapeutic proteins using mammalian cell lines;
- You provide strong scientific and technical leadership in the late stage development of cell lines for the manufacture of therapeutic proteins by mammalian cell culture;
- You build and optimize development and regulatory strategies for late stage biotherapeutic molecules, including commercial process development, process characterization and regulatory filing;
- You author relevant CMC sections of BLA submissions and are a Subject Matter Expert in the scientific application of ICHQ8-11 and related requirements for the generation of appropriate data support packages with BLA submissions;
- You review and approve study protocols and reports for late stage cell culture development to ensure that studies are delivered to the appropriate scientific and technical quality;
- You provide strong scientific and technical leadership in the application of Design of Experiments (DoE) and appropriate cell culture scale down models;
- You are the primary cell culture technical representative for meetings with regulators and addressing technical questions for cell culture processes arising for projects he/she is cell culture lead;
- You provide strong scientific and technical leadership in the identification, evaluation, and championing of new technologies for late stage cell culture development whilst maintaining and improving established technologies;
- You regularly communicate progress of projects by means of both verbal presentations and written reports to internal groups;
- You develop and mentor junior scientists within Process Development.
Requirements
- Bachelor or Master in relevant discipline (e.g. biochemistry, cell biology, molecular biology), desirable PhD in relevant subject (e.g. biochemistry, cell line engineering, biochemical engineering);
- More than 10 years of work experience in the biotech/pharmaceutical industry within a cell culture role and an excellent understanding of the theory and practice of cell culture and protein structure is required;
- A demonstrable and substantial track record in late stage cell culture development with a strong focus on process characterization, risk assessment methods, regulatory submissions, technical regulatory awareness in a biopharmaceutical / biotech company;
- Experience in working in a fast changing working environment related to commercial process development. Knowledge of technical issues with cell culture scale down is required in addition to a strong understanding of DoE principles. A solid understanding of product characterization is desirable. Demonstrated ability to deliver on commitments will be required. Strong evidence of the ability to work in and lead cross-functional matrix teams;
- Excellent communication skills in English, both written and oral. German is a plus;
- Excellent interpersonal skills as well as excellent planning and organizing skills;
- A demonstrable analytical approach to problem solving and goal orientation;
- A passion for scientific excellence in process development.