- Follow-up of commercial manufacturing products in term of organization and chemistry (troubleshooting, out of trend, out of specification, quality issues, Start on time ...) in term of campaigns preparation, follow-up and release with all the associated scientifical /technical aspects.
- Propose continuous process optimization for reducing the cost of good of the current process leading to a long term robust and economical industrial process.
Keep up-date on the literature related to the managed project. - Bring innovative solutions for solving problems and propose Innovative Ideas when applicable which could have a positive impact in our business.
- Preparation and review of batch records, preparation for audits, audit follow-up, assist RA for CMC, NDA, DMF filing.
- Organize documentation and logistics (MBR's, purchasing requisition, BOM, TO, reports, DR; CAPA, CR and Reports
- Participate in technical transfer of new processes (Process development to manufacturing) with the optimal process.
- Carry-out a good support of the manufacturing team : ensuring proper training of the manufacturing production technicians (knowledge on products and processes) to prevent risk of safety accident or project failure, motivating and listening to the personnel, maintaining a sound work spirit.
- Ensure customer project technical communication in a constructive and proactive way.
- PhD in Chemistry or Chemical Engineering
- Upstream Commercial process experience in Pharma of at least 5 years
- Team working
- Safety and GMP environmental rules
- People management
- Excellent knowledge in synthesis process
- Good communication skills (oral and written) with internal and external Customers
- Team spirit
- Be strong key team player among the project teams, able to set the right priorities, customer oriented internal and external
- Organizational skills
- Project management
- Autonomy and flexibility
- Leadership
- Fluent in French and English
Upstream Manufacturing LCM Chemist - Braine-l'Alleud, België - PolyPeptide
Beschrijving
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, timelines, yield, quality, cost improvements)
Manage continuous improvement of processes (e.g. optimization of unit operations, increase quality and yield, waste management, etc...) using the OPEX tools
Ensure the customers (internal and external) required timelines and milestones in compliance with cGMP and safety
Manage the manufacturing process technicians dedicated to the production for commercial manufacturing. Ensure the development and training of the resources including a plan of development if needed.
Ensure customer project technical communication in a constructive and proactive way in order to maintain PolyPeptide's customer relationship as one key competitive advantage
Work closely with the production teams (Team leaders and the Production managers) to met safety, quality, people, cost and supply targets
Role & Responsibility:
Profile: