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Job description
? Oversee analytical activities for the R&D and commercial portfolio
at CROs located in China.
? Provide analytical technical guidance and trouble-shooting support to
analytical teams in CRO and other external partners. Review technical
documents (protocols/reports) from CRO to ensure GMP compliance.
? Ensure cGMP compliance in all aspects of activities performed at CROs,
where relevant.
? Track performance and provide reports on metrics to Management.
? Seek creative approaches to improve the accuracy, reliability,
flexibility and productivity of the analytical development activities in
China.
? Enhance engagement with Health Authorities to help influencing
regulatory landscape in China.
? Closely collaborate in a global environment together with
multidisciplinary teams in China, India, US and Europe.
? Hold a master’s degree in Chemistry, Pharmacy or equivalent with
excellent knowledge of analytics, stability and specs. PhD in same
fields preferred.
? Have at least 5-8 years of senior level industry experience in
global, medium-size pharmaceutical development or research entities or
CRO.
? Broad and strong scientific analytical chemistry knowledge in the CMC
field, which includes but not limited to analytical method development
and validation, GMP release testing, stability study for both API and
Drug Product.
? Strong expertise in CMC small molecules early development, with focus
on moving compounds from discovery to NME and FIH. Experience with
Analytical Development supporting both API and DP is preferred.
Experience of working in a matrix environment together with other
functions (API, DP, RA, QA, …) to deliver on CMC goals.
? Strong interpersonal skills to effectively communicate with external
sites and various internal and external functional areas.
? Good understanding of global Regulatory requirements and ability to
respond as to authority questions.
? Ability to prioritize and balance compliance with business needs.
? Experience of microbial testing is a plus.
? Manager experience is a plus.
Competencies
? Strong leadership skills are required.
? Can work independently, though you are also an excellent team player.
? Efficient, flexible and dynamic.
? Demonstrate capabilities in strategic thinking
? Sense of Urgency
? Excellent communication skills.
? Have a good knowledge of English, both spoken and written.
? Good English scientific writing skills.
? Chinese language is required for working with local CRO’s.