Bioingeniería / biotecnología
Minoryx is a clinical stage biotech company leading the development of new therapies for X-ALD and other rare diseases with a high unmet medical need. The company’s leading program is MIN-102, a novel, orally bioavailable and selective PPAR gamma agonist with a superior profile for central nervous system-related diseases. It is currently in an ongoing phase 2/3 clinical trial for the treatment of adrenomyeloneuropathy (AMN) in EU and US. The trial enrolls adult male patients affected by AMN, the most frequent phenotype of X-linked adrenoleukodystrophy (X-ALD), in Europe and the US, with results expected in 2020. Please visit .
Minoryx is expanding its activities and potential indications for MIN-102 and is now launching a clinical trial in a second orphan CNS indication (Friedreich’s Ataxia). Recently the company opened a second R&D site at the i-Tech Incubator (Brussels South Biopark – Charleroi, Belgium). The company is backed by a syndicate of experienced investors and has support from a network of other organizations. Minoryx was founded in 2011 and has raised more than €50M, including a €21.3M Series B closed in September 2018.
Minoryx is actively looking for a candidate for the position of CMC MANAGER (m/f). The candidate will be located in the Belgian subsidiary but would be expected to maintain close contact with the team located at the HQ in Mataró (Barcelona, Spain) and will be reporting to the Director of CMC. The position includes travels to visit CDMOs as needed.
As a CMC Manager, you support day-to-day CMC internal and external activities in terms of process, technical expertise and operational trouble shooting. You coordinate CMC operations in collaboration with other departments and suppliers.
Your main responsibilities are:
· Monitor in-house and external CMC activities.
· Provide technical expertise for the drug substance (DS) synthesis and processability.
· Support drug product (DP) technical and planning activities.
· Attend both drug substance (DS) and drug product (DP) key productions.
· Identify potential analytical, processing, stability and compliance issues. Troubleshooting.
· Review certificate of analysis, batch records and other technical documents.
· Participates in the regular communications with the CDMOs and technology providers, discussing data, planning.
· Liaise with other departments to provide them the requested CMC information.
· Support in writing and reviewing CMC sections of the IMPD.
De 3 a 5 años
· BSc or MSc degree in Chemistry. Knowledge of pharmaceutical technology will be a plus.
· 3 -5 years CMC experience in small molecules, mainly in drug substance (DS).
· Solid experience in analytical, manufacturing and GMP.
· Good understanding of synthesis, process development and process transfers implementation.
· Agility, rapid response to changes.
· Ability to work autonomously and to collaborate with a group in a goal- and team-oriented setting.
· Effective communication skills.
· Fluency in English (written and spoken).
· Prepared to travel to the Spanish site and the CDMO sites around 15% of your work time.