CMC Development Manager
Vor 2 Tagen
Your mission
As a CMC Development Manager (m/f/d), you will be a key leader in advancing our innovative drug development program. You will take ownership of the development of our products, from analytical method development and validation to drug substance and drug product manufacturing processes optimization. Working closely with multidisciplinary teams and external partners, you will ensure our processes and products meet the highest standards of quality, scalability, and regulatory compliance.
Key responsibilities:
Lead process development activities, including manufacturing process optimisation, material qualification, and compatibility testing internally and with contractors Work closely with R&D to develop and then manage validation of analytical methods for identity, purity, and impurities, utilizing techniques such as UV–Vis, NMR, HPLC, GC, and Raman internally or with contractorsDesign stability studies and impurity profiling to ensure processes are reliable and fit for purpose.Drive drug product development activities, including formulation and sterile process designPlay a key role in coordinating interactions with third-party CDMOs to support outsourced activities.Support scale-up and technology transfer to clinical manufacturing sites.Prepare and review CMC documentation, including experimental reports, protocols, SOPs, and eCTD sections.Work across development, quality, regulatory, and supply chain teams to keep projects aligned and on track.
Your profile
MSc or PhD in chemistry, pharmaceutical science, chemical engineering, or a related fieldAt least 5 years of experience in analytical chemistry, process development, or manufacturing within the pharmaceutical or biotech industryDemonstrated expertise in CMC development, including manufacturing process validation and technology transferStrong background in analytical method development and validation (NMR, GC, HPLC) preferredStrong understanding of and experience working in an environment compliant with GMP, GLP, and ICH guidelinesVery good written and spoken English skills
Why us?
Attractive compensation package, including a competitive base salary and stock optionsImpactful product promoting better understanding and treatment of cancerInternational team, from over 20 different nationalitiesPositive work environment with open communication and a collaborative mindsetRemote or Hybrid working model possible Indefinite employment contract30 vacation days Flexible working hoursAnnual health budget (Allianz bKV)EGYM WellpassRelocation support
contact information
Join us in making a difference Submit your application to be considered for this exciting opportunity.
Any questions? Please contact:
Daniel Sypli
Sr. Talent Acquisition Manager
mail: -
About us
NVision is a quantum biotech startup based in Ulm, Germany, with Tier 1 investors from the USA and Europe. We are just leaving stealth mode, moving from local R&D to global commercialization and expansion.
We are developing a technology that will enable MRI-based imaging of real-time metabolism in the body, with tremendous potential for research and applications in oncology, cardiology, neurology and more. Our company brings together expertise in physics, chemistry, engineering and medicine, and we are collaborating with scientists and clinicians from top medical and research centers such as Memorial Sloan Kettering in New York, MD Anderson in Texas, Technical University of Munich, Cambridge University in the UK and more.
NVision is developing fast, robust and easy-to-use hyperpolarization technology for preclinical and clinical research in our POLARIS product line. Those devices are placed close to an MRI scanner in a research or clinical environment to produce hyperpolarized contrast agents on demand in a fast, fully-automated, multi-step chemical process. Key steps of the process contain fluidic transport across multiple vessels and chemical mixing and separation processes in fully-reuseable or single-use disposable fluid paths. We develop our commercial products jointly with external design and manufacturing partners and the process development as well as the design and manufacturing of prototypes is done entirely in-house.
We offer a dynamic international working environment, with immense room for growth, that encourages personal initiative and open communication.
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