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Biopharmaceutical Integration Specialist
3 weeks ago
We are seeking a highly skilled Biopharmaceutical Integration Specialist to join our CMC Integration Team in New Product Introduction (NPI) CMC. The NPI team is responsible for Early-Stage CMC development covering preclinical to early/mid clinical stage CMC work.
The ideal candidate will have a strong background in bioprocess technology and bioprocess analytics, with experience in developing and implementing analytical/process strategies for selected projects in the Genmab Early-Stage project portfolio.
As a Biopharmaceutical Integration Specialist, you will integrate new/specific required analytical/process strategies into CMC Development Path deviating from Genmab CMC platform.
Key Responsibilities Include:- Managing specific analytical/process activities at CMOs related to Early-Stage projects, ensuring technical excellence and speed into First-in-Human trials.
- Supporting the CMC PM to solve project specific analytical/process tasks with a holistic CMC approach for new antibody modalities or CMC challenges like transfer to new manufacturing sites.
- Authoring and reviewing of regulatory CMC submissions (IND/CTA).
- Supporting and following up on CMO and internal quality events such as changes or deviations.
