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职场十三姨

新虫 (初入文坛)

应助: 0 (幼儿园)
金币: 63.5
散金: 15
帖子: 32
在线: 2小时
虫号: 34282826
注册: 2023-11-20

[交流] 某知名制药公司招聘 CMC lead -可有偿介绍合适人选

具体工作地点:

上海

薪金:

80-150万/年

学历和研究方向:

化学生物化学等

招聘岗位:

寡核苷酸CMC Lead

公司名称:

某知名生物技术公司

联系方式:

请加Echo韦的微信：J873566109

Key Responsibilities:
◼ Lead drug substance / drug product development of oligonucleotides, analytical
development, Quality Assurance and oversight of manufacturing process with external
CDMO and future inhouse GMP manufacturing facility.
◼ Author and review technical protocols and reports in support of preclinical (hundred
grams scale) and clinical stage (kilo gram scale) manufacture and process
characterization activities.
◼ Contribute to strategic technical discussions and present progress at internal and
external scientific meetings.
◼ Lead the preparation of the Drug Product and analytical section of regulatory filings and
effectively represent the CMC function in interactions with regulatory authorities.
◼ Effectively integrate CMC activities with other functions, including chemistry synthesis,
and Regulatory Affairs, and oversight of manufacturing processes.
◼ Track progress against project timelines, generate regular status updates, and
communicate progress and issues to management, including presentation of findings at
team meetings.

Qualifications:
◼ Ph.D. with 3+ years or master’s with 6+ years degree in chemistry, chemical engineering,
biochemical engineering, or pharmaceutical sciences，with prior industry experience in
oligonucleotide or peptide products.
◼ Hands-on experience in process development and process validation of drug products
and dosage forms across multiple development projects including process transfer and
management of contract manufacturing.
◼ Demonstrated management experience of successful drug product process
development teams.
◼ Experience in preparing regulatory documents including briefing documents for
regulatory meetings.
◼ In-depth understanding and hands-on experience in drug product process development,
analytical development and Quality Asssurance.
◼ Hands-on experience in analytical methods for characterization of drug products and
processes.
◼ Excellent leadership, organizational and communication skills.
◼ Demonstrated strong operational execution and problem-solving skills.
◼ Eagerness to learn new techniques.

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