We are looking for a
Head of Chemistry, Manufacturing and Controls (CMC), m/f/x
for an unlimited full-time position in Gräfelfing/Munich.
As the head of CMC you will mainly work with the Chief Operating Officer as well as with other internal and external partners such as CROs.
In particular, you will
- Oversee all drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration at Immunic
- Lead our CMC team in Gräfelfing
- Be in charge for identification, selection and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (API) and Drug Product (DP) in support of ongoing clinical programs
- Design and develop the Formulation and Dosage Forms for the clinical programs
- Manage the supply chain and logistics in support of clinical studies
- Execute plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
- Write and review documents for INDs / regulatory section submissions; represent the company as the CMC expert before U.S. and European regulatory authorities and business partners
- Review or edit cGMP batch records, CMC regulatory and Quality documents related to the production of Drug Substance and Drug Product. As such act as a QA representative for the activities related to the CMC/ GMP activities for specific productions (e.g. review of the MBRs and executed MBRs, specifications, Certificates of Analysis and Conformance)
- Consolidate key cross-functional information and support the management in decision making
Here is how to convince us:
- You have a PhD or MS with at least five years of experience; alternatively, an advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
- You have experience in the pharmaceutical development work related to API and Drug Product, in particular Oral Solid Dosage Forms
- You have good hands-on of Quality by Design and Risk Management concepts
- Experience with projects in clinical development e.g. Phase 1 through Phase 3 including multiple pharmaceutical dosage forms
- Excellent written and verbal communication skills in English, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects
- You enjoy working in a small team as well as dynamic work environment
- You are open-minded and you strive to find the best solutions in a team environment.
- You are able to self-structure your work and drive processes, have good project management skills, and are willing to take responsibility and make decisions
- You are happy to work in a flat hierarchy environment and have a hands-on mentality.
- You have a good cultural fit to the current team of Immunic
What you can expect:
- A small, highly motivated team as well as dynamic and multicultural work environment
- An innovative company that is constantly growing and moving
- An attractive office with good public transport connections to the city center of Munich
Please send your meaningful application specifying your salary expectations as well as the earliest possible starting date by email to Ethan Cortese, Apsida Life Science, email@example.com