CMC Director/Senior Director - Pharmaceutical
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Bullet points
Young potential platform, comprised of professionals with track record
Explicit IPO plan and provide stock option to executives
About Our Client
This is a fast growing biotechnology company with strong pipeline in small molecule drugs. The company is founded by a group of seasoned and renowned scientists and professionals from the industry with track record in drug development and strategic transactions. The company is also financially backed up by the top-tier investment funds.
Their solid connetion and partnership with institutions and contract organisations allow them to have extensive commercial coverage and market access in China.
Job Description
1. As the person in charge of the change of origin of overseas introduced projects, coordinated with overseas partners to clarify all aspects of technical requirements of industrial production, and was responsible for the implementation of the outsourced CMC project's domestic real estate
2. Responsible for the evaluation of GMP production, selection of suppliers from API to preparation and other cross-department suppliers, management and coordination of CMC suppliers, to ensure the smooth implementation and compliance of CMC origin change projects
3. Manage the whole process and project execution of CMC development, and be responsible for supervision, quality control management and qualified acceptance of products
4. Organize the writing and review of IND/NDA related materials according to the relevant domestic and foreign requirements of CMC development
The Successful Applicant
1. Master or doctor degree in pharmacy, chemistry or related field
2. More than 8 years of experience in drug synthesis, preparation, analysis and r&d;
3. Directly participated in or led the industrial production of CMC origin change
4. Proficient in RELEVANT CMC regulations and policies and relevant technical requirements
5. Good leadership, execution, interpersonal communication and organization and coordination skills
6. Working experience in multinational companies or innovative pharmaceutical companies, good English listening, speaking and reading skills
7. Good learning ability, problem analysis and solving ability, cGMP experience is preferred
What's on Offer
- Flexible work time that enables you to work at home 1 day/week
- Attractive remuneration package with stock options
- Promising career development opportunities within the organisation