For a leading bio-pharmaceutical company in Bavaria, we are exclusively looking for a Teamlead Formulation development (m/f/d).
Scientific and organizational lead of the formulation development department including management of laboratory personnel/ direct reports and external resources
Develop robust formulations and select appropriate primary packaging components for biosimilar drug products
Thorough planning, review, and evaluation of laboratory experiments for drug product formulation and method development, process development as well as process characterization, in collaboration with Drug Product and Process Development colleagues and in agreement with current Quality of Design principles
Plan drug product specific analytical methods, such as compendial methods and qualitative and quantitative excipient methods
Support the verification/qualification/validation of the above methods (in house or at external testing labs) and be author of related documentation, as needed
Support the preparation and review of patent applications related to formulation and primary packaging studies
Accountability for the timely execution and reporting of experiments in high quality
Compilation of high-quality scientific documents (e.g. technical documentation package, SOPs, reports, risk assessments, master plans, sampling plans, memos) to hand over to internal and/or external partners (e.g. Quality, regCMC, health authorities, external companies) and support generation of international registration documents (CTD, BB, IMPD, IND etc.).
Master (or equivalent) and 6-7 years of relevant work experience or PhD and 3 years of relevant work experience or other education and relevant work expertise
Excellent knowledge in formulation development of proteins
Very good team player with critical thinking, flexible, result oriented, well organized, proactive, problem solver and able to work independently with attention to detail
Very strong presentation and communication/ leadership skills
Creativity and enthusiasm for working in a dynamic fast-growing biopharmaceutical company
Fluent in written and spoken English required, German knowledge is desirable