清远招聘

Responsibilities:

· Developing formulation strategies for IND and NDA in US and ROW, taking into account technical and regulatory considerations.

· Developing formulation manufacturing processes for both NDA registration and commercialization; organizing all activities associated with clinical batches and NDA batches.

· Creating, reviewing and/or approving technical documents (protocols, batch records, and development reports, etc.).

· Interacting with Manufacturing, Validation, and Materials Management to assure smooth technical transfer and scale up of formulations from development to commercial scale.

· Developing, interpreting and explaining standard practice instructions and procedures, and ensuring that they are complied with.

· Overseeing and/or collaborating with external parties involved with formulation development and/or manufacturing.

Qualifications:

· A science degree is required, preferably in Pharmaceutics or Chemistry. An advanced degree (Pharm D, Masters, or PhD in a science related discipline) is strongly preferred.

· Minimum of 5 years of experience with pharmaceutical development programs,preferably with NDA product development.

· Hands-on experiences in developing and manufacturing solid oral dosage product.

· Solid understanding of cGMP.

· Understanding of FDA,ICH and USP requirements for Drug Product development and manufacturing.

· Excellent interpersonal,supervisory, investigative, and implementation skills.

· Possess excellent written and verbal communication skills. Requires the ability to prepare and review technical reports.

· Experiences in technical transfer,process validation and/or NDA registration in big Pharma is a plus.

· Fluent in written and oral 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。