Senior Drug Substance Scientist - Late-Stage Peptide CMC

Zealand Pharma A/S

Gladsaxe Kommune

In loco

DKK 900.000 - 1.300.000

Tempo pieno

6 giorni fa

Candidati tra i primi

Generatore di candidature

Aumenta le possibilità di ricevere una risposta da questo datore di lavoro — un curriculum e una lettera di presentazione personalizzati, che corrispondono esattamente a ciò che sta cercando.

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Descrizione del lavoro

Zealand Pharma A/S is seeking a Senior Drug Substance Scientist to lead late-stage drug substance development and coordinate CDMO partnerships. The role emphasizes technical transfer, risk assessment, and documentation across development projects.

You will shape CMC strategy and drive regulatory interactions with internal teams and external partners. You will join a seasoned CMC Development group, contributing to submissions and ensuring robust processes, quality, and compliance in late-stage

Competenze

MSc/PhD in chemistry, biochemistry, pharmaceutical sciences, or a related field.
Solid experience in the pharmaceutical industry.
Experience in late-stage process development, scale-up, and preferably process validation (PPQ).
Experience in Solid-Phase Peptide Synthesis (SPPS) and related processes for synthetic peptides is an advantage.
Experience with drug substance outsourcing and CDMO collaboration.
Knowledge of Quality Risk Management (FMEA), GMP, and regulatory requirements in late-stage CMC.

Mansioni

Drug substance late-stage development.
Technical transfer and upscale in development projects.
Managing the collaboration with DS CDMOs, including oversight plans, day-to-day communication, and knowledge transfer.
Supporting development and technical manufacturing activities at CDMOs, including documentation, risk assessments and reports.
Active contribution to the CMC team, working collaboratively on project progress toward regulatory approval — within Zealand Pharma and with external partners.
Driving scientific and strategic input to submissions and regulatory interactions, in collaboration with Regulatory Affairs, partners and CDMOs.