长沙招聘

Description:

This senior level position in biomanufacturing sciences & technologies (BMST), supports Bio-Thera decision-making and product R&D by leading the company’s biomanufacturing sciences, manufacturing technology, and technology transfer. This position in Biologics will focus on the development of scalable cell culture processes, and tech transfer of processes to GMP facilities for manufacturing following ICH guidance. We are seeking an experienced, motivated individual to join the company’s technical and managerial leadership group.

Major Responsibilities:

1. Lead and grow a team of scientists and engineers for biomanufacturing sciences & technologies (BMST) with focusing in 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.

Requirements:

1. Ph.D. in chemical engineering, bioengineering, or relevant disciplines, with more than 10 years of industrial experiences in antibody drug upstream and/or downstream process characterization 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 development laboratory activities. Knowledge of 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;

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.

百奥泰生物制药股份有限公司（股票代码：688177）秉承“创新只为生命”的理念，致力于开发新一代创新药和生物类似药，用于治疗肿瘤、自身免疫性疾病、心血管疾病以及其它危及人类生命或健康的重大疾病。公司已推动五款候选药物进入后期临床试验，其中格乐立（阿达木单抗）已在中国获批用于治疗类风湿关节炎、强直性脊柱炎、银屑病、克罗恩病和葡萄膜炎。此外，公司另有多款主攻肿瘤和自身免疫性疾病的候选药物处于不同的临床开发阶段。公司始终以患者的福祉作为首要核心价值，通过创新研发为患者提供安全、有效、可负担的优质药物，以满足亟待解决的治疗需求。欲了解更多信息，请访问公司官网或关注我们的微信公众号“百奥泰”。
Bio-Thera？Solutions, Ltd.a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing branded biologics to treat a range of cancer and autoimmune diseases. As a leader in next-generation antibody discovery and engineering, the company has advanced five candidates into late stage clinical trials, one of which, QLETLI, a biosimilar to？Humira？(adalimumab), is available to patients with rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis,？Crohn's disease or uveitis in China. In addition, the company has multiple candidates in early clinical trials and IND-enabling studies, focusing on innovative targets in immuno-oncology and autoimmune diseases.