Job Description

工作地点：济南、成都、连云港、南京

岗位职责：

1. 负责改良型新药/一类创新药的立项评估、剂型设计开发、处方筛选和工艺开发及优化工作；

2. 跟踪重要治疗领域的临床需求，进行制剂的改良和创新，实现增效减毒的目的；

3. 密切关注和学习国内外上市和临床研究阶段的改良型新药相关的创新制剂技术、研究思路和相关文献资料，并深入思考、转化和运用；

4.不断加强对制剂相关专业知识的深入学习，并补充跨学科专业知识，如临床药学、药物化学、生物药剂学等，以临床需求为导向，科学设计和开发改良型新药；

5. 深入分析思考和总结药学和体内试验数据，不断建立和完善制剂特性、体内药动学行为和临床疗效之间的关联；

6.记录和整理原始试验记录及相关文件，完成注册申报资料的撰写，并保证其真实性和完整性；

7.完成领导安排的其它相关工作，如引进项目评估、新技术平台调研、新药资讯相关文献查询、内部电子期刊编辑、相关专业技术培训等。

任职要求：

1. 博士，有复杂制剂研（如复杂注射剂、口服缓控释制剂、吸入剂等）发经验者优先，药学、药物制剂等相关专业；

2. 在制药领域拥有广博而扎实的知识和较高的制剂专业技术水平，并具有清晰的科研思路以及较强的分析和解决技术问题的能力；

3. 具有较强的检索和阅读外文资料和文献能力，并可有效提取、梳理和转化文献中的核心专业技术；

4．具有强烈的求知欲望，以及较强的自我学习与探索的能力，乐于接受创新性、挑战性的知识和任务；

5. 熟悉各类药物制剂仪器设备的使用、处方筛选、试验总结报告撰写等日常相关工作；

6. 具有良好的道德修养、心理素质、抗压能力及团队合作精神，能够与同事进行良好的沟通协作。

Job Responsibilities:

1.Lead feasibility assessment, dosage form design, formulation screening, process development, and optimization for 505(b)(2) NDAs and first-in-class innovative drugs.

2.Track clinical needs in key therapeutic areas to drive formulation innovations achieving enhanced efficacy/reduced toxicity.

3.Monitor global innovations in clinical-stage modified-release drugs; translate novel technologies/research concepts into R&D strategies.

4.Deepen expertise in formulation science while integrating cross-disciplinary knowledge (clinical pharmacology, medicinal chemistry, biopharmaceutics) for clinically driven drug development.

5.Establish in vitro-in vivo correlations (IVIVC) by analyzing pharmaceutical data and PK studies to link formulation properties with clinical outcomes.

6.Document experimental records; author regulatory submission documents ensuring data integrity and ALCOA+ compliance.

7.Execute assigned tasks: due diligence for in-licensed projects, novel technology platform assessments, literature reviews, e-journal editing, and technical training.

Qualifications:

1.Ph.D. in Pharmaceutics, Pharmaceutical Sciences, or related field. Preferred: Experience with complex dosage forms (e.g., complex injectables, modified-release oral systems, inhalation products).

2.Comprehensive expertise in drug development with advanced technical proficiency; demonstrated ability to design scientifically sound studies and solve complex formulation challenges.

3.Proficient in literature mining (English journals/patents) with strong capability to extract, synthesize, and implement technical insights.

4.Intellectual curiosity and self-driven learning agility; embraces innovative/high-challenge tasks.

5.Hands-on experience with:Formulation equipment (e.g., fluid bed dryers, hot-melt extruders)、DoE-based formulation screening、Technical report writing.

6.Strong ethics, resilience in fast-paced environments, and collaborative mindset with excellent cross-functional communication skills.

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