Teamlead Formulation Development (m/f/d)

DAS UNTERNEHMEN

IHRE AUFGABEN

• 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.).

IHR PROFIL

• 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
• Proficient in MS-Office
• German work permit is mandatory

BENEFITS

• Excellent work and company culture 
• Flexibility and additional social benefits 
• Working "in the heart" of Bavaria