上海招聘

Major Responsibilities and
Duties

1. Work closely with CDMOs on biologics formulation and process development plan design and project execution.

2. Work as a SME in biologics formulation and process development and provide all kinds of technical support to biologics DP development and production as needed.

3. Oversee CDMOs for biologics formulation and process development, DP manufacturing, stability study, etc.

4. Monitor the project progress in CDMOs and assure timely deliver each milestone.

5. Manage formulation development for liquid and lyophilized product, DP tech transfer, process development, optimization, scale-up, non-GMP and GMP manufacturing, process validation, etc.

6. IND/BLA dossier preparation.

Qualifications:

1. Has MS or Ph.D. degree in biochemistry, chemistry engineering, pharmacy and related fields with at least 2~5 years of industry working experience in big pharma or biotech company.
2. Familiar with biologics drug formulation and process development from early to late stage and to commercialization.
3. Has at least 2 years of experience in biologics formulation, lyophilization process development, optimization, scale-up, tech transfer and process validation, etc.
4. Familiar with ICH, IMPA, FDA, EMA policies.
5. Familiar with regulatory procedure of IND/BLA filing to IMPA, FDA and EMA.
6. Fluent in both English and Mandarin.

天境生物科技(上海)有限公司
天境生物由臧敬五博士领衔的创新药资深研发团队创建，是一家聚焦在肿瘤免疫和自身免疫疾病精准医疗领域的新药研发生物医药科技公司。
公司的核心竞争力在于早期研发、靶点发现和验证、工艺开发&临床前评价、质量科学&质量管理、早期临床研究的能力（包括临床一期和临床二期）。团队在创新药物靶点生物学、创新抗体药物分子结构研发以及创新药物的转化医学及临床研究方面的优势为公司建立一条具有国际竞争力的项目管线创造了基础。公司目前创新药管线含12个在研创新抗体药物项目。领先的创新药项目将在2017年3月申报临床研究并在台湾, 韩国及中国启动临床研究, 其它项目均已进入细胞株或工艺开发阶段。
公司从成立以来已经建立了广泛深入的国际合作, 如与瑞士FERRING公司合作独家引进开发Olamkicept。公司自主研发的全球创新药项目将在2018年进入中国及美国临床研究申报环节并计划在两地启动一期临床研究。