Functions, Duties, Tasks, Key Objectives/Deliverables:

TSMS Management of External CMs & Suppliers

TSMS Management for external CMs and suppliers, to support manufacturing and supply commitment.

1. Practical understanding of process steps and control parameters for all process of CM/supply products. Able to provide a guidance or proficient at data interpretation for key steps in process. Able to lead local improvements and ensure reliable manufacturing.

2. Drives clarity on the core issues when faced by EEM China with a problem within network. Succinctly analyzes data to get to root cause Identifies the best experiments to prove concept. Able to systematically uses data, statistical thinking.

3. Participate to establish/ Maintain TS/MS System at CMs and key suppliers.

4. Technical Transfers: Responsible for supporting successful technical transfers either into or from contract manufacturers. Ensuring that supply remains undisrupted throughout any technical transfers or terminations.

5. Continuous Improvement: Responsible for the productivity agenda, continuously improving work practices, quality and reducing costs.

6. Strong leadership to govern daily TS/MS operations on CMs and suppliers. Serve as primary technical point of contact for manufacturing process and quality controls, and provide technical support to CMs and suppliers.


Operational Management of External CMs & Suppliers

Operational Management and innovational solutions to the all external CMs/Suppliers by operational excellence tools and risk based approach.

1. Projects/Business Ventures: Responsible for working closely with functional leadership on new CMs/suppliers selection and due diligence activities as required.

2. Team Leadership: Indirect leadership with CM product teams. Indirect leadership of employees who support external manufacturing operations.

3. Operational management: Responsible for monitoring and influencing all functional activities associated with manufacturing and product supply from the CMs/suppliers; driving collaboration between functional areas to resolve issues and ensuring reliable product supply and product quality in a cost effective manner.

4. Periodic Assessment: Responsible for completing periodic reviews of CMs/suppliers relationships against set goals and objectives; recalibrating expectations as appropriate. Conduct periodic risk assessments of CMs/suppliers and communication of results to senior management.

5. Relationship Governance: Responsible for forming, facilitating and lead the appropriate governance structure, including the establishment of steering teams, joint process teams, project teams, setting relationship goals and success indicators, driving continuous improvement activities and overall monitoring of performance.

6. Compliance: Responsible for the adherence to appropriate financial, quality, supply chain, HSE, regulatory internal standards as well as internationally recognized standards at the external manufacturers.


Minimum Qualification(experience and/or training, required certifications):

1. Five to Seven years of experience in cGMP pharmaceutical API (Small molecule or Bio; Chemistry/Pharmaceutical/Process engineer; Process development, technical transfer, process scale up, and process validation, etc.) process technical area and with related working experience of HSE ( particular for experience of process safety).

2. Independent technical thinking and Good teamwork

3. Strong problem solving capabilities including strategic and creative thinking

4. Strong interpersonal/communication skills: verbal and written

5. Cross-functional networking and influencing ability

6. Ability to handle multiple priorities and deal with ambiguity

7. Capable of speaking, writing, and reading English fluently

8. Technical project management skills

With following specified experience:

1. Large scale classical fermentation experience and/or chemical process experience specifically.

2. Finishing products experience specifically for animal health premixes.

3. Understanding of global cGMPs for API manufacturing and drug products.


Additional Preferences:

1. Engineering background or experience

2. Understanding of analytical methods.

3. API and Drug Product Packaging Experience

4. Understanding VICH standards and post approval change guidelines

5. Understanding of supply chain methodology - OSSCE concepts

6. Trained in Root Cause Analysis


Education Requirements:

Advanced Science degree (e.g. Chemistry, Engineering, Biochemistry, Industrial Microbiologist) or Bachelors of Science degree with equivalent work experience.

Other Information:

Approximately 30-35% travel: domestically (25%) and internationally (10%).