Biopharmaceutical Development Scientist

Description

LG Life Sciences (www.lgls.com) is actively involved in the development of protein-based therapeutics (including Biosimilar mAbs) for prevention or treatment of human diseases, and has an extensive pipeline of products in various stages of R&D.  LG Life Sciences is currently seeking a highly motivated scientist or engineer to work in the following groups of the Biopharmaceutical Institute.

1) Upstream group:

The upstream group is responsible for the development, scale-up, characterization, and transfer of manufacturing processes for mammalian expression (primarily CHO) based projects, and prepares regulatory filings. The successful applicant will help develop scalable and robust upstream processes to meet target process yield requirements, product quality attributes, and project timelines. The job will involve development of fed-batch culture process, pre-clinical materials supply, scale-up and tech-transfer to the manufacturing site.

2) Biopharmaceutical manufacturing group:

The biopharmaceutical manufacturing group is responsible for facility construction, manufacturing operations including clinical and commercial production. The role also involves implementation of process improvements for existing manufacturing processes (cell culture and purification).

3) Regulatory Affairs and/or Clinical Research group:

The regulatory affairs group is responsible for reviewing and preparing responses to inquiries from regulatory authorities related to product registration. The role also monitors and updates registration requirements through review of publications, seminars, and direct communication with regulatory bodies.

The Clinical research group is responsible for design, implement and monitor clinical studies of biopharmaceuticals (especially Biosimilar mAbs) designated for clinical development.  The role also reviews requests for results of IND studies, provides input for PK and pre-clinical studies, and prepares clinical portions of IND, NDA and BLA.

Qualifications

Candidates will have a Ph.D. or M. S. in chemical engineering, biochemical engineering, or any other relevant biological sciences, and ideally, at least five years of experience in the biopharmaceutical industry. Also, retirees from the biopharmaceutical industry are welcome and may be hired as a full-time consultant. The hiring level (Research Scientist/Engineer, General Manager, and Director) will be commensurate with the level of experience.

Desirable Experience, Knowledge, Skills and Abilities:

- Basic knowledge of GxP and regulatory requirements of the biopharmaceutical industry

- Ability to solve problems by leveraging both internal and external resources as well as the literature

- Strong technical writing skills for report writing and support of regulatory submissions

- Excellent organizational and communication skills, along with the ability to share technical knowledge effectively with a range of personnel. This also includes the ability to mentor and motivate junior personnel.

1) Upstream or Manufacturing group

- Technical expertise in various subject matters related to CHO process development such as media/feed design and optimization, operation and control of fed-batch fermentors, process scale-up, and tech-transfer to pilot plants and/or commercial scales.

- Experience with statistical design of experiments, scientific data analysis, and mathematical modeling

- Ability to design cell culture/purification process development experiments, to perform or supervise experimental work, and to analyze data and provide timely and accurate preparation of experimental results.

Primary Location: Daejon/Osong/Seoul, Korea