广州招聘

职位1 Senior Formulation Scientist in R&D

We are inviting a hands-on and result driven formulation scientist to join our team in supporting the formulation development of innovative drugs.

Responsibilities:

Exploratory formulation screening for portfolio enablement. Assess biopharmaceutical performance of botanical and small molecule drug candidates. Evaluate enabling technologies to optimize drug delivery and absorption. Perform in-silico simulation for formulation evaluation. Evaluate dissolution methods and support clinical pharmacology through approaches including in-vitro-in-vivo correlation.

Collaborate with other functional areas in discovery including DMPK and toxicity, and all CMC functional groups and clinical team including clinical supply operation and external contractors.

Qualifications:

Graduate degrees in Pharmaceutical related Sciences or Engineering. Hands-on experience of typical solid dosage unit operations, as well as technologies for delivery and absorption enhancement is must. Experience in analytical tools for formulation screening, and developing PBPK models with software such as Gastroplus or similar is a plus.

Independently initiate and finish formulation R & D projects. Familiar with NMPA, US FDA and ICH guidelines.

Good communication and positive interpersonal skills. Fluent in English.

职位2 制剂研究员

岗位职责：

1． 各种药物制剂产品的研究开发，特别是口服固体制剂产品。

2． 药物制剂处方设计、工艺开发与优化

3． 产品技术转移、放大生产、工艺验证与临床样品GMP生产

4． 撰写研究方案、开发报告和新药申报注册文件（涉及中国及海外注册）

5． 进行部分药物分析研究工作和临床前制剂开发

任职资格：

1． 硕士及以上学位，两年以上药剂开发相关经验

2． 良好的各种剂型的开发与GMP生产经验

3． 有GMP经验并熟悉新药研发及申报的申请者优先考虑

4． 有处方前研究经验者优先考虑

5． 良好的项目管理经验、团队工作能力和解决问题能力

6． 英语听、说、读、写能力良好

Formulation Scientist

Responsibilities:

1. Formulation research and development of various dosage forms, especially on oral solid formulation.

2. Formulation manufacturing process optimization

3. Technology transfer, process scale-up and validation, GMP production for clinical supply

4. Writing study protocol, development report, IND and NDA submission documents for SFDA and FDA

5. Pharmaceutical analysis and preclinical formulation development.

Qualifications:

1. Master or above degree in pharmaceutical science with at least 2 years related working experience

2. Extensive knowledge on development and GMP production of various dosage forms.

3. Current knowledge and experience of GMP, IND and NDA will be preferred.

4. Pre-formulation experience will be a plus.

5. Strong team-working skills and problem-solving capability.

6. Good written and oral communication skills in Chinese and English.

和黄中国医药科技有限公司（简称“ 和黄医药 ”或“ Chi-Med ”）（纳斯达克 / 伦交所：HCM）是一家创新型生物医药公司，在过去20年间致力于发现和全球开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。目前，和黄医药共有8个抗癌类候选药物正在全球开发中，并在中国本土市场拥有广泛的商业网络。

和黄医药成立于2002年，为在纽约和伦敦两地上市的和黄中国医药科技有限公司（纳斯达克/伦交所： HCM）旗下专注于新药研发业务的子公司, 研发中心坐落在上海浦东张江高科技园区，海外临床开发及注册中心位于美国新泽西，具有完备的研发平台和GMP生产基地。管理团队成员均有在知名跨国医药和生物医药企业工作的经历，参与了多个全球新药研发；公司目前有500余位来自海内外，拥有丰富新药研发经验的科研人员，8大临床在研药物、 30多项临床试验在全球开展。

和黄医药是一家致力于创新药物研发的生物医药公司，专注于发现和开发治疗癌症和自身免疫性疾病的靶向药物和免疫疗法。 自主研发的抗肿瘤新药呋喹替尼已于2018年9月获国家药品监督管理局批准上市，并于2019年11月获纳入国家医保药品目录。公司的其他候选药物，如索凡替尼、沃利替尼等，也已进入后期开发，有望在2020及2021年上市。