Lead Biopharmaceutical Development Specialist
3 weeks ago
Advance Therapeutic Innovation with a Meaningful Mission
Symphogen, as the Antibody Center of Excellence in Servier, is committed to developing superior monoclonal antibody therapeutics to improve patients' lives. As a Lead Biopharmaceutical Development Specialist, you will join the Drug Product Development Department and contribute to this mission.
This role involves strengthening drug product process development and manufacturing, and/or overseeing GMP stability studies in collaboration with Contract Manufacturing Organizations (CMOs). You will work closely with staff from the CMC Biologics group and be part of international cross-functional project teams to ensure development progress.
The Drug Product Development department's responsibilities include:
- Drug product process development for liquid and lyophilized products
- Oversight of clinical drug product manufacturing for liquid and lyophilized products
- Non-GMP and GMP stability studies for drug substances, drug products, and reference materials
- Formulation development
- In-use compatibility studies
- Authoring documentation for regulatory authorities
To succeed in this role, you should have a minimum of two years of relevant industry experience, preferably with knowledge about physical and chemical properties of proteins, as well as Good Manufacturing Practice (GMP) principles. Experience in biopharmaceutical manufacturing or stability studies is a plus.
You must hold a master's degree in a relevant field, such as pharmacy, pharmaceutical sciences, or a related discipline. Self-motivation, pragmatism, and effective teamwork skills are essential. A proactive attitude, strong commitment to your work, and good communication skills are also required.
We offer a challenging job in a dynamic, goal-oriented environment with a meaningful mission. You will be part of a highly engaged organization that values diversity, teamwork, commitment, and individual growth. Good development opportunities and a competitive benefit package are available.
Working Conditions: Limited travelling (approximately 10 days per year) and based in Ballerup, Denmark.
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