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河北快3和值综合走势 www.djdmb.tw Position:

 

Director of Chemical Development

Job description

As chemical development lead for Laekna therapeutics, this role will be responsible for all chemical development activities for drug substance to support Laekna’s pipeline products at different stages ranging from preclinical, clinical, and commercialization. He/she will oversee all chemical development related activities through active coordination and communication internally and externally to meet project timeline. He/she will serve as chemistry expert and provide technical leadership to promote Laekna’s scientific competitiveness.

Your Key Accountabilities

1.      Responsible for chemical development of drug substance (DS) including but not limited to raw material selection, chemical process development and optimization, and DS manufacturing.

2.      Responsible for planning and execution of DS supply strategy to support Laekna’s clinical program and commercial product launching

3.      Responsible for IND/NDA dossier writing and relevant regulatory documents to support Laekna’s product registration with FDA/CFDA and other regulatory agencies.

4.      Serve as chemistry expert and provide technical leadership to both internal and external collaborators to ensure rigid science in Laekna’s product development and meet project timeline defined by upper management

5.      Oversee all chemistry related functions through internal management and external collaboration to ensure project progress

6.      Enhance awareness of chemistry functions and provide technical training internally to better align internal resources

Your Skillset

1.    Master with over 10 years or PhD with over 8 years working experience in big pharm or biotech companies directly involving chemical development and manufacturing for various chemical products.

2.    Familiar with regulatory CMC requirements for FDA/EMA/CFDA and have rich experiences in writing IND/NDA dossiers to different regulatory agencies for multiple products.

3.    Strong leadership and excellent management skills to oversee multiple projects for fast progress and timely communication with upper management and relevant parties.

4.    Self-driven initiative and willing to work in startup environment to learn, share, and grow.

Our Offer

We offer you an open biotech culture, an exciting journey throughout the world of drug clinical research and development. You can expect to work with a successful, highly-qualified and dynamic team as you develop your individual scientific and management skills, and entrepreneur competency. You can also look forward to a flexible working environment, a pleasant and homelike atmosphere as well as competitive incentive package. If you are looking for a big stage for your profession or beyond, if you are willing to walk out of your “comfortable zone” in your career, come and join us!