Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
New Product Development Lead
YOUR TASK & RESPONSIBILITIES
- Coordinate new product development/transfer based on agreed specification, cost, technology, and timeline in order to meet with product launching expectation/implementation.
- Coordinate with respective colleagues from PS to develop the formula and process based on QTPP, agreed lab scale experiments, pilot batch, feasibility and non-commercial validation in the area of pharmaceutical development of new products, specifically for pre-formulation and formulation studies
- To provide BOM and routing information for COGS calculation, and machine capacity calculation for manufacturing evaluation in regards of new product/site transfer
- To provide required documentation (protocol, Risk Assessment, BOM, etc.) related to development activities. Collect report and summarize data of experimental work and present them in professional & scientific way. Also supporting Dossier creation and preparation related to manufacturing part, batch composition, packaging and validation part in regards initial dossier, any changes or up-date versions.
- Working with cross-functional function (inter-department) related with development activities. Perform follow up of different research activities with other related function. This includes assisting in troubleshooting of existing products and launching of new products/site transfer.
- Implement current good manufacturing practices & QBD concept for product development.
WHO YOU ARE
- Education: Preferable as apothecary/pharmacist
- Min have experience in pharmaceutical industries 3 - 5 years
- Main competencies for the job (Core, Leaders, technical competencies)
- Familiar with product development projects and formula development.
- Having knowledge in GMP principles, regulations, project management, production and packaging process, stability study, change management and supplier qualification.
Reference Code: 259281
Functional Area: Quality