Upstream Process Development Chemist

il y a 5 jours

Brainel'Alleud, Belgique PolyPeptide Temps plein

We are looking for a Chemist for our Process Development Upstream whose main responsibility will be the development and management of the upstream processes for API. Nature & Scope: Develop and manage upstream process development projects from the initial steps to the validation of the process, with the optimal productivity, cost and environmentally-friendliness, in order to maintain PolyPeptide in a world-wide leadership position. Ensure the customer required timelines and milestones in compliance with cGMP and safety. Role & Responsibility: In collaboration with customer project team, develop the downstream processes: At the level of the laboratory, define and organize all experimental work needed to design/qualify processes in terms of quality,robustness, productivity and safety, fitting with requirements and timelines of the customers Manage the process scale up and manufacturing batches (cGMP) including development, qualification and validation batches (in collaboration with manufacturing department). Manage all the associated documentation (MBrs, DMR, protocols, development reports, change over, …) and logistics with the supply chain department (Raw materials, planning, …….). Maintain operation in compliance with the cGMP PPG quality system (preparation and review of batch records, preparation for audits, audit follow-up, assist RA for CMC, NDA, DMF filing Ensure succesful transfer of the process as Braine process giver to the Braine manufacturing or as process receiver for Technology transfers from others PPG sites to Braine Work as part of the project team to meet the project timelines and the budget. Regularly keep the customers (both internal and external) informed all over the different phases of the project program, through projects team meetings, regular conference calls and weekly written updates (Plan-do-check-adjust). Support manufacturing for troubleshooting activities and process optimization Contribute to the maintenance of the scientific excellence of the department in the field of downstream process and evaluate the possibility to implement innovative ideas and new technologies allowing to improve quality and productivity Contribute to the enforcement of a quality environment and system specifically designed for development activities Contribute to the laboratory organization, equipment management. Sustain 5S, lean management and SHE rules Ensure the people management of the technical staff devoted to the corresponding project programs (direct and dotted reports) Contribute to the harmonisation of technical practises and documentation following the global Development guidances. Profile: PhD in Chemistry or Chemical Engineering Upstream Process Development experience in Pharma or fine chemistry of at least 5 years Excellent knowledge in Upstream Process Knowledge of peptide ; an experience in scaling-up/production and in pharmaceutical industry (GMP) is an asset. Understanding of quality standards and health & safety regulations Position requirements: strong interpersonal, communication and leadership skills are essential to fulfill this role, plus excellent team spirit, adaptability to priorities adjustment and entrepreneurial skills. Fluent in French and English

  • Upstream Manufacturing LCM Chemist

    il y a 2 semaines

    Braine-l'Alleud, Belgique PolyPeptide Temps plein

    We are looking for a Chemist for our Upstream Manufacturing Life Cycle Management. Nature & Scope: Manage upstream commercial manufacturing products in term of campaigns preparation, follow-up and release with all the associated scientifical /technical aspects in order to assure that the manufacturing products are running according to expectations (safety,...

  • Downstream Process Development Chemist

    il y a 3 heures

    Braine-l'Alleud, Belgique PolyPeptide Belgium Temps plein

    We are looking for a Chemist for our Process Development Downstream whose main responsibility will be the development and management of the downstream processes for API. **Role & Responsibility** In collaboration with customer project team, develop the downstream processes: - At the level of the laboratory, define and organize all experimental work needed...

  • Clinical Manufacturing Process Engineer

    il y a 2 semaines

    Braine-l'Alleud, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Clinical Manufacturing Process Engineer who is innovative, detail-oriented, and collaborative to join our Clinical Manufacturing team, based at our UCB campus located in Braine-l'Alleud, Belgium.About the roleYou are going to play a key role in shaping the future of biologics and gene therapy at UCB. You...

  • Production Team Leader

    il y a 2 semaines

    Braine-l'Alleud, Belgique PolyPeptide Temps plein

    PolyPeptide Laboratories is a high-tech enterprise specializing in the development, manufacture and sale of  therapeutically active peptides . PolyPeptide SA, Belgium, with approximately 320 employees is part of the international PolyPeptide Group with companies in Sweden, India, USA, France and Belgium.  To strengthen our Manufacturing Department based in...

  • Technicien Process

    il y a 3 heures

    Braine-l'Alleud, Belgique PolyPeptide Belgium Temps plein

    PolyPeptide Laboratories est une entreprise high-tech spécialisée dans le développement, la production, et la vente de **peptides actifs thérapeutiques**. PolyPeptide SA compte approximativement 320 employés et fait partie du Groupe international PolyPeptide, avec des filiales en Suède, Inde, Etats-Unis, France et Belgique. Pour son Département...

  • Senior Scientist

    il y a 2 semaines

    Braine-l'Alleud, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Drug Product Development Scientist who is innovative, detail-oriented, and collaborative to join our Biologics Drug Product Development team, based at our UCB campus located in Braine-l’Alleud, Walloon Brabant, Belgium.About the roleYou’re going to play a key role in shaping the future of injectable drug...

  • Biophysical & Mass Spectrometry Scientist - Gene Therapy CMC

    il y a 2 semaines

    Braine-l'Alleud, Belgique UCB Temps plein

    Make your mark for patientsWe’re looking for a Biophysical Mass Spectrometry Scientist who is analytical, collaborative, and solutions-oriented to join our Gene Therapy Analytical Sciences team based at our UCB campus located in Braine-l’Alleud, Wallonia, Belgium.About the roleIn this role, you’ll lead the development and implementation of...

  • Raw Material Scientist

    il y a 4 heures

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a Raw Material Scientist who is detail-oriented, collaborative, and proactive to join our DSPS team, based at our UCB campus located in Braine-l’Alleud, Belgium. About the role You will be responsible for coordinating a comprehensive strategy to identify critical/key raw materials during development to...

  • New Product Introduction

    il y a 4 heures

    Braine-l'Alleud, Belgique UCB S.A. Temps plein

    **Make your mark for patients** We are looking for a **NPI Expert** who is a dynamic team player to join us in our **Internal Manufacturing** Department, based in **Braine-l’Alleud**, **Belgium.** **About the role** **As a NPI Expert you are the Field Representative for NPI (New Product Introduction) activities and the main contact for knowledge...

  • Gene Therapy Downstream Process Sciences Senior

    il y a 4 heures

    Braine-l'Alleud, Belgique UCB Temps plein

    **Make your mark for patients** We are looking for a **Gene Therapy Downstream Process Sciences Senior Scientist** who’s **dynamic, resilient and flexible** to join us in our **Gene Therapy Process Development** team, in **Belgium** **About the role** The **Gene Therapy (GT) Downstream Process Sciences Senior Scientist** will be responsible for...