苏州招聘

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Job Description:
Design, plan, perform, interpret and report results of scientific experiments for the preparation and timely delivery of drug substances (DS), drug products (DP), processes and procedures within a multifunctional project team coordinated by a Project Leader.
Manage technical lab/plant activities. Responsible to support submission document preparation concerning CMC parts of CTAs, NDAs. Post Approval Changes (Supplemental applications) according to the agreed timelines to get the approval in China.
1. Prepare high quality CMC documents to support business needs in development.
2. Prepare high quality CMC documents to support TechOps and other company division for local marketed products.
3. Support preparation of necessary submission documents in collaboration with Reg CMC and DRA.
4. Support preparation of answers to questions from Chinese Regulatory Bodies after CTA, NDA or Post Approval filing in China according to the agreed timelines.
5. Meet quality, quantity and timelines in all assigned projects.
6. Perform scientific experiments/plant activities and plan, perform and contribute to project related scientific/technical activities under minimal guidance from more experienced team member (e.g., interpret and report results, generate and evaluate data, draw relevant conclusions, write reports).
7. Provide efficient and robust processes for the manufacture and/or analysis of intermediates, DS and DP under adequate guidance from more experienced team members.
8. Generate scientific documents to hand over to internal and/or external partners, e.g.,TechOps, authorities, external companies) and support generation of international registration documents under adequate guidance from more experienced team members.
9. Actively contributes to team goals.
10. In partnership with DRA and RegCMC, contribute to Health Authority interactions and negotiations as appropriate;
S&T Specific Activities :
1. Perform scientific experiments. Provide efficient and robust processes for the manufacture and/or analysis of intermediates, drug substance and drug product as per own discipline.
2. Report and present scientific/technical results internally and contribute to publications, presentations and patents.

Requirements:
1. Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
2. Desired: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry,Biotechnology) or equivalent.
3. Languages: Fluent English required (oral and written). Fluent in (local) language desired.
4. Experience/Professional requirement:
1) 3-4 years in drug/biopharmaceuticals development or equivalence.
2) Working knowledge/experience in pharmaceutical development and regulatory submission document preparation.
3) Proven track record of successfully working in in-terdisciplinary teams.
4) Regularly demonstrated active contributions to line functions or project teams, as well as ability to con-tribute to matrix teams with the necessary strategic thinking.
5) Ability to work on multiple projects under pressure of time and workload.
6) Excellent written/spoken communication
7) Computer literacy.