武汉招聘

职位描述：
We are looking for a CMC Director/Associate Director to oversee the chemistry, manufacturing, and controls of a compound for pre-clinical study and clinical trials.
This position provides a phenomenal opportunity for a talented individual who seeks exposure and participation across all dimensions of a very well-positioned biotechnology company's growth.


Job Purpose and Key Responsibilities:

Evaluate and select API and drug product CMOs:

1. Be the primary liaison with CMOs. Manage and monitor CMOs for tech transfer and development of new and existing API and drug product. Scale-up, manufacturing, and packaging for pre-clinical study and clinical trials products.
2. CMO Quality (QA) and Regulatory assurance (RA).
3. Support CMOs during the development and validation phases of projects.
4. Help to preparation and submission of CMC sections of IND and NDA, including responses to questions from FDA.
5. Maintain awareness and act as expert on CMC requirements.
6. Provide CMC input to the discovery project team.


Qualifications / Requirements: (Education / Experience / Competencies):

1. Masters or Ph.D. ( >5 years) in Chemistry, or Analytical, or Chemical Engineering.
2. Industry experience in API synthesis and drug product formulation development, scale-up, manufacturing, packaging, technology transfer registration and QA/RA.
3. Knowledge of CMC, product development, product quality, manufacturing.
4. Experience in outsourcing, vendor management, establishing and managing consultants and CMOs for timely, clear, and accurate deliverables
5. Deep understanding of QA, RA, regulatory and clinical functions to guide CMC and CMC-related clinical activities
6. Proven ability to communicate (English written/oral) with various functions, to coordinate, influence and lead a virtual team
7. Ability of cross functional co-operation.
8. Strong ownership and cross boundary working mindset.
9. A strong capability in problem solving
10. Strong ability of lobby, influence and negotiation

Preferred Requirements:
Relevant to the role, but not critical/essential
1. Strong formulation knowledge/experience is preferred
2. Chinese and English 举报 分享

诚聘