Job Description
Founded in 2019, Pentixapharm AG is a research-driven biopharmaceutical company specializing in radiopharmaceuticals for the diagnosis and treatment of cancer and inflammatory diseases. Our focus spans preclinical and clinical development, as well as the manufacturing of innovative theranostic drug candidates, including the PentixaFor/PentixaTher peptide pair and an antibody-based pipeline. Our clinical-stage drugs specifically target the CXCR4 receptor, a key driver in aggressive diseases such as hematologic and solid cancers and cardiovascular conditions.
Pentixapharm AG is looking to strengthen the team in Berlin with a
CMC Manager (m/f/d)
Are you ready to drive the development of cutting-edge radiopharmaceuticals? We are looking for a proactive and determined CMC Manager to join our team. In this key position, you'll work at the intersection of science, manufacturing, and clinical development, helping bring life-changing therapies to patients worldwide.
Your Tasks
- Oversee end-to-end development and GMP manufacturing of radiopharmaceuticals across all phases.
- Manage CMO and supplier relationships to ensure timely, high-quality clinical supply.
- Prepare and review CMC sections of regulatory submissions (INDs, IMPDs, etc.).
- Ensure GMP compliance through audits, quality systems, and deviation management.
- Drive process improvements and foster cross-functional collaboration.
- 3+ years in CMC for radiopharmaceuticals (radiolabeling experience a plus).
- M.Sc. (or equivalent) in Chemistry, Radiochemistry, Pharmaceutical Sciences, or related field.
- Strong knowledge of clinical-stage drug development, GMP, and regulatory requirements.
- Excellent problem-solving, communication, and collaboration skills.
- Fluency in English and German.
- Meaningful mission: Develop innovative radiopharmaceuticals that improve patients' lives.
- Impactful work: High responsibility in a dynamic, science-driven environment.
- Flexibility: Flexible hours, hybrid work at Campus Berlin-Buch.
- Attractive benefits: Pension scheme, job ticket subsidy, team events and company meetings.