Position 1: Project Manager

Main responsibilities:

1.Monitor the progress of the project and collect statistical data,

2.Participation in review of change control and deviation during production campaign and review campaign report,

3.Keep track of sourcing and purchasing of raw materials and shipment of product during a project / production campaign and ensure timely completion of relevant reports,

4.Keep track of technical document transfer and structure the documents

5.Allocate resource across departments for the implementation and continual improvement of the project plan,

6.Coordination with Swiss counterpart (if applicable) for cross-site project management,

7.Coordination with technical lead (development chemist) on trouble shooting,

8.Establish and maintain effective communication with customer and Swiss colleagues (if applicable) by regular information sharing, conference call and progress report, etc

Qualifications:

-A PhD in Organic Chemistry or equivalent,

-With good oral and written English,

-With good GMP knowledge and general concept in drug substance regulation

-Over 5 years of experience in GMP API manufacturing preferably 2 years in project management.

Position 2 : Senior Development Chemist

Key Responsibilities

Coaching

- Coaching of junior chemists, technicians and interns.

Project Management

- Manage project from technical prospective

- Attend conference call with customers and Swiss colleagues

- Draft and review of project reports and campaign reports

Lab Work and Maintenance

- Process research, development and troubleshooting of processes to be carried out in CGAM Shanghai, including technical transfers

- Perform synthesis and purification of impurities

- Perform experiments in new Hipo Lab environment

- Perform Kilo Scale preparation

- Documentation and report of experimental results

GMP activities

- Preparation and review of MBR

- Support process validation and perform associated activities (e.g. PAR study, risk analysis)

- Support cleaning validation

- To perform Use tests

Process and lab Safety

- Support process safety risk analysis, participate in HAZOP

- Perform Lab maintenance to keep labs in safe and good 5S conditions

- Support and perform deviation investigations

Qualification

- PhD degree in organic chemistry or related filed, experienced master degree holder with excellent English can be considered

- With over 2 years of experience in process development 

- Good written and verbal English, can participate in conference call in English

- Good understanding in GMP and ICH guidelines

- Be able to work independently and drive collaborative projects forward by drawing conclusions and communicating recommendations to the project team

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