YOUR TASKS AND RESPONSIBILITIES
- Actively participate in regular governance and project management meetings to drive business and Quality performance goals in CMO network
- Lead manufacturing and packaging process validation of new products developed by Bayer, at Contract Manufacturers (CMOs) located mainly in China (could also be other countries). Review and approve validation protocols and reports.
- Shared responsibility with Innovation & Development, Perform Product Transfer from existing network, Partner with CDMOs in process validation in New Product Developments (NPDs) including OTC, Health Food, General Goods, Cosmetics, Medical Deceive and etc.
- Join the DD audit for external in-licensing candidates, estimate from technical perspective, follow CAPA accordingly, follow and support to figure out issue.
- Provide input/guidance into resolution of production issues/deviations to ensure continuity of supply
- Follow-thru on joint process technology related CAPA commitments with CMO network
- Champion and promote sharing of technical knowledge within global team
- Connect and partner with global team members to drive continuous improvement of business processes within aimed at delivering on the strategic goal of optimizing the CMO network
- Manage technical changes at CMOs (e.g. qualification of new sources of raw material, site transfers)
- Maintain a site-based portfolio of technical process improvements aimed at delivering year-on-year savings to be shared between Bayer and the CMO
- Evaluate new CMOs for technical capabilities
- Be able to manage at least 6 CMOs or in-licensing sites with high complexity
WHO YOU ARE
- Minimum BS or equivalent degree in Chemistry, Chemical Engineering, Pharmacy, or in a relevant Life Science discipline
- Minimum 5 years of relevant technical experience in the small molecule pharmaceutical industry, covering the following functions: Process Technology ；Technology transferfrom R&D to manufacturing plant, or from plant to plant ；Process validation ；Technical Services ；Manufacturing ；Product Development
- Minimum 5 years of experience working with pharmaceutical industry
- GMP knowledge
- International experience is a plus
- Experience in general food, nutritionals, cosmetic and medical device a plus
- Lean six sigma or Operational excellence certification is a plus
- Fluent in Business English, written and verbal, with ability to communicate with all levels of employees, multi-lingual is a plus
- Ability to travel up to 25% of time, within China and internationally.
- Strong flexibility to adapt to different business cultures
- Strong analytical and problem-solving skills
- Be able to work independently
If your background and personal experience fit this profile, please send us your complete application at www.career.bayer.cn If you have any recommendations, please kindly send mail to [email protected]
China : ShangHai : ShangHai
To apply for this job please visit career.bayer.cn.