1. 招聘职位
  2. 工作地点
  3. 招聘人数
  4. 发布日期
  5. 应聘

岗位职责

1.负责或参与临床研究项目的方案设计及医学撰写工作,和项目实施团队合作确定完善方案及其它临床试验医学文件;
2.负责对临床研究项目团队进行方案培训;
3.负责对在研临床研究项目的医学支持工作包括研究者、项目经理以及CRA在项目实施过程中的医学问题解决等;
4.负责申报资料中临床试验部分的审核及专家答疑;
5.上级安排的其它工作。

任职要求

1.医学、药学等相关硕士以上学历,临床医学背景优先;
2.至少2年以上制药企业或CRO公司相关工作经历;有肿瘤项目和自身免疫性疾病项目经验的优先;
3.熟悉药品注册管理办法、药品临床试验及GCP等相关法规;
4.具备熟练的英文听说读写能力,熟悉使用计算机及办公软件;
5.有良好的人际关系和良好的沟通及语言表达能力。

岗位职责

1. Implement and maintain a high standard quality assurance procedure according to current ICH guidance including China, EU and US GMP regulations. Ensure the compliance of GCP, GMP and other GxP regulatory been always met during the clinical trial, commercial manufacturing and post marketing; 

2. Monitor all production and QC test process, perform necessary on-site inspections and batch records reviews to make sure all the manufacturing and QC tests meet the predefined process specification and compliance requirements for data integrity prior to the final release of the product; 

3. Lead and monitor the deviation investigations, CAPAs, risk management, self- inspections, change controls, and other quality activities. Prepare and lead all regulatory audit/inspection. Be ready to address all quality related issues and take the responsibility of corrective actions and continuous improvement of the performance of quality system within the company; 

4. Review and approve the quality system procedures and documentations which covering the life cycle of drug product, from clinical trials, commercial production and post-marketing monitoring; 

5. Prepare the regulatory audits and inspections according to product submission progress and other triggers, responsible for corrective actions and continuous improvement of QA procedures; 

6. Conduct and lead the investigations, CAPAs, deviations and Quality Risk Management and other activities during the GxP operations. Responsible for the other quality related tasks assigned to Quality Head by management team as per urgent needs or company strategy; 

7. Ensure the implementation of effective business processes, procedures and practices in alignment with regulatory expectations and company policies for data integrity through its lifecycle, including GxP computer systems, hybrid systems and manual/paper systems;

8. The Job Title will be assigned by company management according to candidates experience and capability.

任职要求

1. Graduate Degree (or above) in Pharmaceutical related majors including pharmaceutical sciences, medicines, biochemistry, biological sciences, etc; 

2. Minimum 12 years’ working experience in Pharmaceutical industry, 8 years’ experience in Quality assurance of GMP or GxP environment. Experience of sterile manufacturing quality management is a plus; 

3. Familiar with quality assurance procedures according to Chinese cGMP, EU/US GMP, GxP, GCP, ChP, EP and USP, and other applicable international guideline such as ISPE, PDA, ICH, etc;

4. Good oral and written English required, must be able to read English protocols/reports, articles, etc;

5. Overseas working experience is a plus.

岗位职责

1.Lead and grow a team of scientists  and engineers for process development with focusing in upstream processes for antibody  therapeutics using sound scientific and engineering principles to design robust  and scalable upstream processes, in consideration of various bioreactor  configurations and process formats.  

2.Lead tech transfer to GMP  manufacturing including risk assessment and mitigation strategy development. Lead and take part in cross-functional collaborations to meet project timelines and DS supply requirements.

3.Ensure all experiments and  activities are documented appropriately; lead in preparation and submission of  CMC portions of regulatory submissions and updates (IND and BLA)

4.Design, manage and support  process characterization studies and develop control strategies for process  validation. Provide direction, support, and corrective action as needed.

5.Present scientific and  technical findings in conferences or publish in journals.

任职要求

1.Ph.D. in chemical engineering, bioengineering, or relevant disciplines, with more than 10 years of industrial experiences in antibody drug upstream process development and biomanufacturing.

2.With a proven track record of accomplishments in the design, development, and implementation of bioreactor cell culture processes including trouble-shooting and decision making.

3.with hands-on experience with upstream development laboratory activities. Knowledge of upstream process equipment at development and pilot scales; proven technology transfer and scale-up experience.

4.Demonstrated ability to simultaneously manage multiple projects, and to function in a collaborative/team oriented environment.

5.Demonstrated ability in leading the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA); Good verbal and written communication skills.

6.Experience in working effectively in multicultural environments is a plus. The company is headquartered in Guangzhou, China, and the position is full-time. Bio-Thera provides competitive compensation package including company stock.

应聘职位
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