Client: PolyPeptide
Location:
Job Category: Other
EU work permit required: Yes
Job Reference: 2ec7d1fc38be
Job Views: 24
Posted: 23.01.2025
Expiry Date: 09.03.2025
Job Description:
We are looking for a Chemist for our Upstream Manufacturing Life Cycle Management.
Nature & Scope:
Manage upstream commercial manufacturing products in terms of caigns preparation, follow up, and release with all the associated scientific/technical aspects to ensure 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 to maintain PolyPeptides customer relationship as one key competitive advantage.
Work closely with the production teams (Team leaders and the Production managers) to meet safety, quality, people, cost, and supply targets.
Role & Responsibility:
1. Follow up of commercial manufacturing products in terms of organization and chemistry (troubleshooting, out of trend, out of specification, quality issues, Start on time) in terms of caigns preparation, follow up, and release with all the associated scientific/technical aspects.
2. Propose continuous process optimization for reducing the cost of goods of the current process leading to a long term robust and economical industrial process. Keep up to date on the literature related to the managed project.
3. Bring innovative solutions for solving problems and propose innovative ideas when applicable which could have a positive impact on our business.
4. Preparation and review of batch records, preparation for audits, audit follow up, assist RA for CMC, NDA, DMF filing.
5. Organize documentation and logistics (M ''s, purchasing requisition, BOM, TO, reports, DR; CAPA, CR, and Reports).
6. Participate in technical transfer of new processes (Process development to manufacturing) with the optimal process.
7. Carry out good support for the manufacturing team: ensuring proper training of the manufacturing production technicians (knowledge on products and processes) to prevent risk of safety accidents or project failure, motivating and listening to the personnel, maintaining a sound work spirit.
8. Ensure customer project technical communication in a constructive and proactive way.<