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
for chemical development of drug substance (DS) including but not limited to
raw material selection, chemical process development and optimization, and DS
for planning and execution of DS supply strategy to support Laekna’s clinical
program and commercial product launching
for IND/NDA dossier writing and relevant regulatory documents to support
Laekna’s product registration with FDA/CFDA and other regulatory agencies.
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
all chemistry related functions through internal management and external
collaboration to ensure project progress
awareness of chemistry functions and provide technical training internally to
better align internal resources
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.
with regulatory CMC requirements for FDA/EMA/CFDA and have rich experiences in
writing IND/NDA dossiers to different regulatory agencies for multiple
leadership and excellent management skills to oversee multiple projects for
fast progress and timely communication with upper management and relevant
initiative and willing to work in startup environment to learn, share, and
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!