Amgen Drug Product Technologies Lead (Principal Scientist) – m/f/d in Munich (Research), Germany
This position is located at the Amgen Research (Munich) GmbH, one of Amgen’s state-of-the-art Research and Development facilities. Its product development pipeline includes novel antibodies generated with its proprietary BiTE® technology.
Our Process Sciences Team is seeking a full-time Drug Product Technologies Lead (Principal Scientist) – m/f/d who is driven to understand the challenges of a biopharmaceutical company with focus on Research and Development. In your role as Early Operations Lead and Drug Product Team Lead in global early phase CMC-Project Teams, a cross-functional interaction with US sites (west and east coast) is required on a regular basis to align on and to coordinate projects and cross-functional imperatives.
Your responsibilities include
Scientific and disciplinary leadership of the local Drug Product Technology team
Responsibility for the technical assessment of early development candidate molecules (Molecule Assessment)
Planning and coordination of studies to optimize formulations for BiTE® antibody constructs and other large molecule pipeline candidates applying experimental design (DoE) strategies and to assess the fit to internal drug product platforms
Transfer of Drug Product manufacturing processes to internal and external GMP facilities
Implementation and advancement of analytical methods to support formulation and process development activities for new drug candidates
Planning and coordination of stability and compatibility studies.
Contribution to the Module 3 of CTA (Clinical Trial Applications) and regulatory interactions
Supporting the preparation of the Investigational Product Instruction Manuals (IPIM)
Supporting clinical programs during the interaction with regulatory agencies and addressing questions related to clinical administration
Leading and coordinating of global CMC development projects while ensuring timely supply of clinical test materials compliant with the Quality Target Product Profile
Contributing to the optimization of internal processes as well as cross-functional and regional interfaces
Initiation and support of overarching innovation projects in the process development area
What we expect of you
PhD degree (or equivalent) in Pharmacy/Chemistry/Biotechnology or related disciplines
10+ years of relevant experience in Pharmaceutical Industry, ideally including people manager experience
Significant experience in protein formulation and analytics as well as Drug Product manufacturing
Comprehensive understanding of the CMC regulatory landscape, experience in leading CMC-projects is beneficial
Excellent English and German communication and presentation skills (both written and spoken)
Problem solving skills and ability to balance opportunities and risks
Demonstrated planning, prioritizing and resource management capabilities
Capability to adapt strategies based on current insights and management guidance
Ability to proactively build productive cross-functional collaborations
High level of flexibility and agility, pronounced team spirit
At Amgen we provide a collaborative and creative culture with a strong track record of innovation. Our culture supports open dialogue and diverse views to land on the best solutions, and we help ensure our staff are equipped to excel today and tomorrow and have opportunities for professional and personal growth. We ensure a diverse and inclusive work environment to successfully sustain and grow as a global enterprise and deliver for patients.
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.