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| Position |
Job Description |
Job Requirements |
연구팀장
Formulation
Team Leader |
1. Endocrine, CNS-related New project development
- Endocrine system, CNS-related Idea generation,
New project creation
- Business model analysis, Analysis of Technology and
Risk, New project development planning
2. Formulation design & research
- Formulation research : Formulation research for IMD and generic
- Process parameter optimization : Pilot Scale up, Preliminary stability
3. Non-clinical study Management
- Animal PK, Toxicology & TK, CRO management
4. Management of tech-transfer for manufacturing process
- Discussion for manufacturing process transfer with Plant team
- Document and Formulation Process Transfer
5. Management of intelligent intangible asset and documentations
- Writing several documentations of IND and
CTD related product approval
- Patent application
6. Team management
: Team KPI setting, coaching for performance improvement,
management goals, communication, training, motivation
7. Resource management
: Appropriate allocation of the resource for formulation study |
1. More than 12 years-experience
in related field
2. Master's Degree or above, majoring
in pharmacy, pharmaceutics or
related field
3. Good communication skill,
New project initiation ability,
Knowledge Related to pharmacy or
pharmaceutical engineering,
Organizational behavior, etc. |
연구원
Formulation
Specialist |
1. Extensive Literature Review
- Researching the developmental project within technique.
(papers, patents, markets, competitors, etc.)
2. Formulation study
- Formulation study of incrementally modified drug and/or generics.
- Optimizing the manufacturing process: Scale up
study and proving the product’s stability.
- Review and interpretation of the Pharmacokinetic data
3. Process development for GMP manufacturing
- Tech-transfer of manufacturing process:
Documentation and tech-transfer of formulation to the GMP site.
- Preparing the draft of batch records & records for new projects.
4. Preparation of documentation for approval and Intellectual Property
- Preparing the documents for approval: Writing the reference
for IND approval and CTD
- Management of project’s patent
5. Junior researcher coaching
Coaching and training for improvement of researcher’s capability
and communication of team members and related team |
1. More than 6 years-experience in
related field
2. Master's Degree or above, majoring in
Pharmacology, Chemistry, Life Science,
Chemical Engineering,
Polymers or related specialist
3. Good communication skill,
knowledge related to formulation
development, CTD preparation skills, etc. |
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