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Position
                      :
 Director of Biologics CMC

Function                     :   CMC

Location                     :   Shanghai

Reporting line            Head of CMC

 

About Laekna Therapeutics

Founded in December 2016, Laekna Therapeutics is a startup biotech company focusing on innovative drug discovery and development. Motivated by the high unmet medical needs of the patients, we are dedicated to developing new targeted therapies to treat cancer and liver diseases. Laekna has strong expertise in both small molecule and antibody discovery and development. Our CEO, Dr. Chris Lu, and the leadership team all have extensive R&D and management experience in global pharmaceutical companies, along with an exceptional track record of new drug approval and marketing. Laekna is a young company full of energy and innovation. Our talented scientists are striving to solve the biggest problems in healthcare and to bring breakthrough medicines to patients.

Job description

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

Major responsibilities

1.    Responsible for process development of biologics product including but not limited to cell line development, cell culture and protein purification process development, and formulation development to enable Laekna’s product for clinical studies and commercialization

2.    Responsible for planning and execution of GMP manufacturing of antibody product to support clinical studies and commercialization.

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

4.   Serve as antibody CMC 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 antibody CMC related functions through internal management and external collaboration to ensure project execution

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

Requirements
1.     Master with over 10 years or PhD with over 8 years working experience in big pharm or biotech companies directly involving antibody process development for various large molecule product including mAb, Bis-mAb, fusion protein, ScFv, Fab, and single variable VH and VL domains, etc.
2.      Familiar with regulatory CMC requirements for FDA/EMA/NMPA and have rich experiences in writing IND/BLA 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 strong willing to work in startup environment to learn, share, and grow.


Contace Information: hr@laeknatp.com