Anticipates scientific and technological developments in the field of microbial DSP and drives the implementation of innovative technologies. Ensures high-quality documentation, including experimental plans, reports, risk assessments and technical
In this role, you will provide expert support for clinical trial quality, ensure compliance with ICH-GCP and global regulatory expectations, and act as a key partner to internal teams and CROs. You will be responsible for quality oversight, process
You will provide communication expertise and lead a strategy-driven approach to authoring of key clinical and regulatory documents and regulatory submissions, to ensure clarity, credibility and consistency of clinical information throughout submission
You will be responsible for leading cross-functional regulatory CMC activities to ensure timely preparation and delivery of high-quality regulatory submissions that support product development, registration, and lifecycle management. This position
Lead the development of new chemical entities with a focus on Drug Substance matters. Lead manufacturing and scale-up activities toward API including supplies of building blocks, Regulatory starting materials or GMP intermediates