- 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.
- 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
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Upstream Process Development Chemist - Braine-l'Alleud, België - PolyPeptide
Beschrijving
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:
Profile:
