You will join the Drug Product Development department, which is responsible for formulation development, compatibility studies, drug product process development, oversight of clinical manufacturing and stability studies. Furthermore, they author documentation for the authorities.
As Senior Drug Product Scientist, you will be responsible for strengthening the drug product process development in late-stage projects in collaboration with CMOs. In addition, you will work with e.g. formulation development, compatibility studies, drug product manufacturing and GMP stability studies. Moreover, you will collaborate closely with staff from the CMC Biologics group and be a member of international cross-functional project teams, to ensure development progress.
With direct report to Director, Drug Product Development.
Your main tasks are:
- Development of processes suitable for drug product GMP manufacture
- Scientific oversight of drug product activities outsourced to external partners
- Project team member of drug development CMC teams
- Leading Drug Product Subteams as Drug Product Coordinator stability assessment of antibodies for the development
- Development of DS and DP formulation
- Pharmaceutical development (in-use stability, compatibility studies, leachable/extractable studies, container selection, excipient quality, pharmaceutical tests)
Your qualifications are several years of experience from the pharmaceutical industry with drug product manufacturing of biopharmaceuticals incl. GMP and regulatory aspects. Moreover, you possess solid knowledge about the physical and chemical properties of proteins.
It is an advantage if you have experience with formulation development and experience in collaborating with CROs/CMOs. Preferably, you also have experience with injection devices and/or lyophilization and with compatibility studies and/or extractable and leachable evaluation.
You have a relevant Master’s Degree, e.g. cand.pharm., cand.scient., cand.polyt., or equivalent.
As a person, you are self-driven, highly motivated, a team player with commitment, initiative and humor. You possess an attention to detail and the ability to work in a team-oriented culture, where knowledge sharing and idea generation with peers is key for advancing next-generation antibody products. Finally, you are to work efficiently and goal-oriented in a multi-disciplinary setting with many different priorities.
Symphogen offers a challenging and versatile job in an innovative, flexible, focused, and committed biotech environment. Moreover, they offer strong cross-functional teamwork, room for individual performance and development, and passionate, inspiring, and fun colleagues.
Travelling: 10-15 days per year.
Domicile: Symphogen’s office in Ballerup.
Unique Human Capital is handling the recruitment. For more details about the job or the company, please contact Unique Human Capital, CEO Jørn Duhn on: jd@uhc.dk or Senior Research Consultant Elisabeth Haun on: elh@uhc.dk. All applications must be in English and are treated confidentially.
You can apply directly via this link: https://uhc.dk/en/available-jobs/senior-drug-product-scientist/
Company
Symphogen is a subsidiary of Servier and antibody center of excellence primarily focused on oncology and immune oncology. We have a highly efficient antibody discovery and research platform supported by comprehensive early development capabilities.
Our antibody platform delivers antibodies with unique functionalities providing best or first in class potential as combination or mono therapy. Our approach and capabilities are well suited for combination therapies at the core of future cancer treatment.
Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 120 people