1. ¼Ò¼Ó ÇìµåÇåÆÃ ȸ»ç¸í: Á¦ÀÌ¿¡ÀÌÄ¡¿¡ÀÌÄ¡¾Ë-JHHR /
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2. ¼Ò¼Ó ÇìµåÇåÆÃ»ç ȨÆäÀÌÁö: http://www.jhhr.co.kr
3. ¼Ò¼Ó ÇìµåÇåÆÃ»ç ȸ»ç ÀüȹøÈ£: 82-2-567-7407 (Á÷Åë)
4. ¼Ò¼Ó ÇìµåÇåÆÃ»ç ȸ»ç¿ë, À̸ÞÀÏ : jhkwak@jhhr.co.kr
5. Æ÷Áö¼Ç ÁøÇà ÇìµåÇåÅÍ¸í ¹× Á÷±Þ : °û Áö Çý ´ëÇ¥ ÄÁ¼³ÅÏÆ®
[±¹³» À¯¸Á º¥Ã³] Head of CMC(¼ö¼®¸Å´ÏÀú ~ ÀÓ¿ø±Þ) ¸ðÁý
¢Ã Position : [±¹³» À¯¸Á º¥Ã³] Head of CMC(¼ö¼®¸Å´ÏÀú ~ ÀÓ¿ø±Þ) ¸ðÁý
1.ÀÇ·Ú»ç: [±¹³» À¯¸Á º¥Ã³±â¾÷]
Key Responsibilities :
¡á To lead and manage all CMC activities of the Company
- Oversee and manage all CMC activities, ranging from cell line development to clinical material production
- Regularly communicate with CDMO to manage progresses and check any issues
- Prepare, review and manage documents related to CMC activities
- Plan annual CMC budget and manage expenditures throughout the year
¡á Represent the Company to internal/external sponsors
- Effectively communicate with related internal teams (Research and Clinical)
- Keenly communicate with CDMO and related authorities (MFDS and FDA)
Qualifications :
¡á Must
- MS in biology-related majors
- 10+ years of experiences in biotherapeutics-related CMC activities (e.g. antibody, recombinant protein), including the following:
Managing tech transfer and clinical material production
Preparing IND submission (CTD documentation)
- Strong communication skills, including business fluency in English
¡á Preferred
- PhD. in biology-related majors
- Experiences of leadership role in early development activities related to IND submission
- Native or conversational fluency in English
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¢Ã ±Ù¹«Áö : °æ±â
¢Ã Á¦Ãâ ¼·ù : ±¹¹® À̷¼ ¶Ç´Â ¿µ¹® CV
¢Ã ´ã´çÀÚ: °ûÁöÇý
¿¬¶ôó : 82-2-567-7407(Á÷Åë)
À̸ÞÀÏ : jhkwak@jhhr.co.kr |