CMC Development Manager (m/f/x) | Ulm / remote | Pharma
In this role you will be taking a key role in the development of a GMP compounding device that will be used at hospitals at the point of care to prepare innovative injectable MRI contrast agents.
What will your activities as "CMC Development Manager" involve?
You will lead reagents, product and formulation characterisation, validation and controls in accordance with the FDA/EU CMC regulations. This includes Drug substance and Drug Product characterisation and controls, with the support of our internal research team in chemistry and physics for formulation and analytical development.
You will play a key role in the sourcing of parts, materials, reagents and their validation studies from external vendors and CDMO (familiarity with the ecosystem of GMP suppliers/CDMO - a big plus).
You will lead the coordination of these suppliers with the other parts of the project.
You will play a key role in the support of NVision's engineers and physicists in the design and the manufacture of our GMP compounding device, regarding specifically GMP sterile process related topics.
You will work closely with regulatory and quality experts to ensure successful FDA review of the CMC sections (i.e., work with experts to define validations and controls, guide writeup of CMC sections of the different regulatory dossiers).
You will take on the overall CMC project management
What does this position as "CMC Development Manager" offer to you?
Salary: very attractive salary package
Contract type: unlimited
Vacation: 30 days / year
Working time: 40 hours / week
Accessibility: Very good transport connections by public transport; sufficient parking spaces available
Start date: At the next possible date
Location: On-site in Ulm or remote with ad-hoc travelling to Ulm on a regular basis
This position is a key role in a cutting edge startup with an excellent perspective for the future, wide freedom for bringing your own ideas and space for personal development. This role combines in depth cutting edge research with development of impactful products!
What requirements should you bring as "CMC Development Manager"?
Master's degree or PhD in pharmaceutical sciences (e.g. pharmaceutical, chemistry, biologics, industrial pharmacy, biomedical) or a related field.
5+ years of professional experience in industry working on pharmaceutical development and tech transfer in a GMP environment (US/EU)
Hands-on experience in drug substance and drug product pharmaceutical and analytical developments (small molecule, sterile, injectable).
Hands-on experience in participating in GMP development projects (sterile process) and CMC regulatory activity for clinical or commercial pharmaceutical products (US/EU)
Demonstration of independent work and initiative in development of drug products, preferably with experience leading and managing projects involving management of CDMOs.
Experience in working in an interdisciplinary team
Experience in contrast agents CMC and/or drug device combinations is a plus
Information about our customer:
Our client is an innovative quantum technology startup that was spun off from the University of Ulm and is backed by tier-1 investors from Silicon Valley and Europe. Their mission is to leverage their unique know-how and IP in quantum technologies to become a front-runner in the development and commercialization of novel medical imaging modalities. This technology will advance the diagnosis and treatment of cancer, cardiovascular diseases, and neurological disorders.
I look forward to your application!