Analytical Development Senior Manager

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.
Qualifications
Education & experience
• You hold a master’s degree in Chemistry, Pharmacy or equivalent with excellent knowledge of analytics, stability and specs. PhD in same fields preferred.
• You 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.
• You 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.
• You 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.