Associate Director / Director - Analytical Development

We are seeking an Associate Director / Director - Analytical Development to become an integral part of our team!

Responsibilities:

• Responsible for technical and operational leadership for Analytical Development team involved in generic small molecule product analytical development activities for successful exhibit batches and for timely FDA submissions with minimal deficiencies.

• Responsible for successful outcomes in developing and validating analytical methods, as well as stability and formulation testing, necessary to support the goals and objectives of generic small molecule product development.

• Manage CMOs and CROs for analytical activities for drug substances and drug products including method transfer, release testing, stability testing, and review/approval of related documents.

• Provide technical input in the investigation of OOS and OOT root causes and/or anomalous results investigation.

• Author and/or review analytical related ANDA regulatory documents.

Qualifications:

• PhD with no less than 10 years related generic sterile injectable or oral dosage analytical development experience of increasing responsibilities within a pharmaceutical setting, or BS/MS with more than 15 years of the same.
• Experience to include analytical development and validation, performance and coordination of stability studies, troubleshooting, and responding to non-standard corporate needs.
• Previous successful management and project management experience is required.
• Proven outstanding communication and collaborative skills.
• Experience of working with CMOs/CROs is preferred.
• Bi-Lingual (English and Chinese Mandarin) preferred.

If interested, please send your resume to hr@praxgen.com