We are looking for a
CMC Project Manager (m/f/x)
for an unlimited full-time position in Gräfelfing/Munich.
As our CMC Project Manager, you will mainly be working with our Head of CMC as well as with other internal and external partners of Immunic. We anticipate a broad scope of activities:
- Executing tasks for achieving the strategy of Immunic concerning the development of the products of the portfolio under the supervision of the department head
- All drug substance and drug product activities from preclinical development through clinical supplies for Phase 3 registration studies for specific products part of the company portfolio
- Helping the Head of CMC in the 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
- Developing and implementing strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs
- Delivering of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
- Anticipating the API and DP needs for preclinical and clinical programs (with clinical team) in compliance with the associated budgets (with finance team)
- Designing and developing the Formulation and Dosage Forms for the clinical programs
- Managing the supply chain and logistics in support of clinical studies
- In coordination with Quality Assurance, implementing stage appropriate analytical methods and protocols and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
- Executing plans for the validation and registration of API and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations
- Writing and reviewing documents for INDs / regulatory section submissions; represent the company as the CMC expert before U.S. and European regulatory authorities
- Providing support to department head to prepare, 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)
Here is how to convince us:
- You have a PhD or MS with 3+ 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 applied to the development of NCEs
- 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 used to work on your own initiative but with high team spirit and the ability to network within the team
- 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 Erika von der Decken, firstname.lastname@example.org.