CMC Drug Substance Specialist

Job Purpose

 As Minoryx is growing, we are currently looking for a talented CMC Specialist (in Drug Substance) to strengthen the CMC Department to support their development programs and product launch. You will report to the Director of CMC activities.

 This position is an excellent opportunity to contribute actively to the advancement and the growth of a Phase 3 stage company while contributing to the development of a promising treatment. This role will be key in the growing organization.

Your responsibilities

In this exciting role as CMC Drug Substance Specialist, you will be responsible for the following: 

• Monitor in-house and external CMC activities. Facilitate development and oversee execution of CMC activities.
• Manage CDMOs for process last optimizations, scale-up, process validation and cGMP manufacture.
• Provide technical expertise for the drug substance (DS) processability, scale-up, manufacturing and testing.
• Manage analytical activities and stability plans.
• Attend drug substance (DS) key productions.
• Identify potential chemical/technical, analytical, processing, stability, and compliance issues and recommends mitigation for emerging risks.
• Review certificates of analysis, batch records and other technical documents.
• Ensure DS supply for clinical studies and product launch.
• Support in writing and reviewing CMC documents for INDs/IMPD/regulatory section submissions.
• Liaise with other departments to provide them the requested CMC information. Ensure alignment with cross functional team. 

Requirements

• BSc or MSc in Chemistry.
• 3-5 years CMC experience in small molecules, in drug substance (DS) from technical point of view.
• Good understanding of DS synthesis, process development, scale-up and process validation.
• Experience in analytical techniques, manufacturing and GMP.
• Substantial experience working with CDMOs and leading their teams is a plus.
• Open-minded with strong team spirit and excellent interpersonal skills.
• Ability to contribute to a continuous learning and process improvement environment.
• Agility, rapid response to changes.
• Ability to work independently and to collaborate with a group in a goal- and team-oriented setting.
• Effective communication skills.
• Fluency in English (written and spoken). 

Our offer 

• A dynamic and ambitious work environment in a high qualified and experimented small team, with daily interactions with the headquarters in Spain.
• Permanent contract, full time job
• Location: Gosselies + 20% travelling + 2 days teleworking/week
• Start date: ASAP 

How to apply? 

If you are interested in this challenging opportunity, please address your application (CV and short motivation text, both in English) to our recruitment partner, Plus One:

Mr Philippe Dortu, by email on pdortu@plusonesearch.be or apply on www.plusonesearch.be Only selected candidates will be contacted.

Biostatistician

Job Purpose

As Minoryx is growing, we are currently looking for a Biostatistician. You will report to the Director of Clinical Operations.

 This position is an excellent opportunity to contribute actively to the advancement and the growth of a Phase 3 stage company while contributing to the development of a promising treatment for a rare disease with a high unmet medical need.

Your responsibilities

As a biostatistician, you will have multiple tasks such as:

Preparation of the study project

• Elaborate on the statistical section of the clinical trial synopsis and protocols. Calculation of the sample size and deciding which statistical analyses should be performed for the primary and secondary endpoints of the clinical trials.
• Supervising the statistical analysis plan (SAP) prepared by the CROs who support Minoryx in the performance of the clinical trial.
• Supervising the CRO programming and outputs generated for each clinical trial.
• Coordinate service providers: scientific organisations, data suppliers, statistical experts, and CROs.

 Exploitation of data and production of results

• Exploiting the scientific data collected, extracting useful data.
• Carry out tests (consistency, cohesion) or statistical learning and the necessary application adjustments.
• Carry out data analysis in a descriptive form.
• Interpret the results and translate them into statistical form.

Writing and publishing results

• Validate and write the statistical part of the clinical documents: study outline and protocol, statistical analysis plan and report, and scientific publications.
• Ensuring the presentation of statistical results to the health authorities in support of regulatory dossiers and in professional events.

 Methodological monitoring

• Ensure a prospective watch on scientific studies, programming methodologies and new tools.
• Follow scientific and technical news.
• Participate in professional exchanges in your speciality. 

Requirements

• Bachelor/Master's degree in (Bio)Statistics, Mathematics, Natural sciences or Health-related field.
• At least 3 years of experience as a Biostatistician
• Experience in clinical trials
• Knowledge of CDISC standards (ADAM) is a plus, not mandatory
• Familiar with SAS
• Previous experience in a Biostats department of a pharma/biotech/Stats department of a CRO
• Autonomous
• Sense of organization
• Accuracy and attention to detail
• Ability to work independently
• Fluent English
• Good communication skills 

Our client’s offer

• A dynamic and ambitious work environment in a highly qualified and experimented small team, with daily interactions with the headquarters in Spain
• Permanent contract, full-time job
• Location: Gosselies + 2 days teleworking/week
• Start date: ASAP 

How to apply?

If you are interested in the position, you can send your CV to our recruitment partner PlusOne at the following address:  tleonard@plusonesearch.be