简体中文
欢迎加入来凯医药

共同打造一流医药研发企业

开发创突破性新药造福病患


Position:  

Director of Analytical Development

 

Function:   CMC

 

Location:   Shanghai

 

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

 

Major responsibilities

1.      Responsible for drug substance related (SM/IPC/IM/FP) analytical method development, validation/verification and transfer to support Laekna’s pipeline products

2.      Responsible for drug product related (SM/IPC/IM/FP) analytical method development, validation/verification and transfer to support Laekna’s pipeline products

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 analytical 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 analytical related functions through internal management and external collaboration to ensure project progress

6.      Responsible for internal capability buildup to support potential manufacturing facilities

7.      Enhance awareness of analytical 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 analytical method development and validation for various product including API, excipients, drug product, etc.

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 strong willing to work in startup environment to learn, share, and grow.