Senior Associate CMC for the Stability Team Alternative
6 days ago
We are seeking a Senior Associate to join our CMC Stability team in Copenhagen, Denmark. This position will report to the Team Lead for the Stability team and will be responsible for ensuring that stability activities are conducted compliantly and executed according to project timelines.
Responsibilities:- Handle stability studies in partnership with Genmab QC, CMC PMs, QA, and CMOs, including stability protocols, data, reports, and non-compliances.
- Responsible for continuous oversight of the stability profile, including trending and setting of shelf life/expiry date.
- Oversee stability testing activities performed at Genmab and at CMOs.
- Support authoring of regulatory stability sections and participate in response rounds with Health Authorities when needed.
- Contribute to improving how we operate within the team and with stakeholders.
- A relevant scientific education on the level of master's degree or related technical area.
- A background working within the pharma/biotech industry.
- Knowledge and understanding of stability testing for products in clinical development and marketed products.
- You are passionate about our purpose and genuinely care about transforming the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do, believing in our science-driven approach to problem-solving.
- You are a collaborative team player who can work with diverse backgrounds.
- You are determined to deliver high-quality results and take pride in enabling your colleagues' success.
- You are comfortable with ambiguity and have experience working in fast-growing companies.
Salary Estimate: €60,000 - €80,000 per annum
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