上海招聘

Keywords: Pharma / Nutrition / Animal Health / Pet / Food Producing Animals / CMO / Contract Manufacture Organization / Product Development / Technical Transfer / Industrial Development / GMP / Pharma Regulations / Regulatory Affairs / QA & QC / Quality

Job purpose:

• In coordination with China Team, will oversee all new product development and manufacturing projects whether done through partners, CMOs or by itself.
• The main objective will be to ensure that the expectations in terms of development, timing, quality, regulations and budget are met by the different partners and suppliers.

Permanent assignments (to be described according to their order of importance, with the most important first):

1. Coordinate and Support NPR, Pharma, Bio & Non-Pharma Regulated new product development and manufacturing transfer from Overseas or R&D site into Chinese manufacturers

Main activities:

• Contributes to the selection of partners and contractualisation of the manufacturing transfer
• Facilitates the cooperation with international manufacturing teams
• Controls the execution of the transfer in China
• Ensure the partners (manufacturer, and R&D at least) are generating all the data required development and for registration purposes
• Ensure the link between the Chinese partners and China company + HQ people (those involved in the projects and more particularly the Corporate NPR, Pharma and BIO R&D people based in Europe)

Expected results: Organize the selection, support and controls of manufacturing process transfer to Chinese partners as well as all activities related to the development of new products

2. Supervise and Contract Manufacturing:

Main activities:

• Ensure the specific projects contracts are signed and endorsed by China along with clear and realistic timelines, macro plan and study plans in alignment
• Ensure the study plans are duly executed according to the specific plans and ensure the company is organizing regular steering committees as well as scientific committees to inform the company and HQ on the progress of the projects.
• Ensure the follow-up of development budgets as agreed per the specific project contracts
• Looks for & identifies potential CMOs
• Studies the technical feasibility of industrial production of new products at CMO level. Defines with CMO the material and human resources needed to produce them in accordance with cost, quality and lead time requirements
• Performs quality audits at CMO level to assess its ability to comply with China company's standards (c-GMP or Food Safety and EHS compliance standards)
• Ensures that supply & quality agreements are in place
• Ensures that Quality practices, systems and procedures are adhered to so that all products, related information and services are compliant with China company specifications and regulatory requirements, and that products are released based on China company's expectations.

Expected results: Ensure the supervision of the new products development according to plans and contracts and ensure production in China of company products as per the contractual specifications

3. Supports Industrial development and Transfer of locally developed products:

Main activities:

• Member of the Local R&D Steering committee in charge of transfer to CMO
• Ensures CMO capabilities and technologies are aligned with the formulation developed
• Ensures technology transfer from Development to Manufacturing is completed on time and effectively
• Oversee the drafting and completion of procedural and technical documentation
• Sets optimized tech transfer timelines
• Plan, design, schedule, conduct and co-ordinate the technical and management aspects of projects
• Coordinates locally the overall project in cooperation and with support of Corporate and Regional stakeholders
• Escalates timely any concern in terms of manufacturing, quality and/or supply
• Write appropriate technical reports

Expected results: to ensure production in China of locally developed brand products as per the contractual specifications. Plan, design, schedule, conduct and co-ordinate the technical and management aspects of tech transfers

4. Staff Organization, Training and Development:

Main activities:

• Ensures CMO or in-house staff are properly trained to execute Production, Quality and Compliance expectations. Drive alignment and assist on executing agreed plans to close any expectation gap between the parties (monitoring points, documentation, QA system...)
• Proposes the China organization to support the production at CMO partners or own sites
• Supervises the QA and QC functions and monitors deviations and inconsistencies with the teams to set the appropriate CAPAs
• Ensures that product releases are made at the right responsibility level in the organization

Expected results: To make sure our CMO or our teams have the right set of skills to produce our products as per the expected specification

5. Update regularly our understanding of the new products registration and Manufacturing regulations:

Main activities:

• In cooperation with the China Regulatory Affairs Manager the New Product Development and Manufacturing Project Manager does a Regulatory Monitoring to adapt our new product development plans and compliance standards if need be.
• Performs regularly gap assessments per product/CMO to warrant we are up to date Regulatory/Compliance wise
• Provide technical input to enable operational compliance to Regulatory and Quality objectives

Expected results: To update regularly our R&D and Industrial Development teams of the regulatory environment affecting our products

KNOW-HOW: job-related skills required to complete activities:

1. Experience with manufacturing of drugs or (preferably) vaccines as manager or business controller or project manager (typically for new constructions).
2. Ability to evaluate data and technical reports
3. Technical background preferred (Pharmacist, Biologist, Engineer)
4. Experience in Project Management and Technology Transfer, implementation of technical solutions and improvements
5. Quality, Compliance and Regulatory background would be a plus (specially around the new Decree #3 (new c-GMP in China)
6. Excellent command of English
7. Preferably experience in Multicultural environment (experience with foreign companies)
8. Good communicator / negotiator /Collaborator
9. Strong interpersonal skills (influence/integrity/relationship)
10. Adaptability to wide range of stake holders (local and international)

We are a foreign firm who is specialized in providing different consulting and business supporting for diversified world-wide companies.