POSITION SUMMARY
This CMC Project Lead and Manager will be responsible for formulating company product CMC strategy, planning and execution. He/she will support a few company projects in all CMC aspects of product devel-opment from clinical Phase I to commercialization. The CMC Project Lead will focus on the CMC strategic and operational aspects of the program while also supporting the team in making complex cross-functional decisions (e.g., scenario planning, risk assessment, setting strategic priorities). This role will report to the VP, and director of the company.
Responsibilities
1、Planning, and execution of key program CMC initiatives and mile-stones to support corporate goals.
2、Lead the project CMC team in making complex cross-functional rec-ommendations / decisions
3、Lead and manage project meetings and agenda topics, facilitate dis-cussions, propose/recommend key decisions, and follow up with action items.
4、Ensure alignment of objectives, plans, and activities across various CMC functions (e.g., R&D, Process Development, Analytical Chemistry, QC, QA, Manufacturing, Regulatory Affairs, Supply Chain, etc.).
5、Familiar with operational aspects of the program and produce doc-uments and visual tools to facilitate project tracking and progress (e.g., decision and action logs, planning trackers, timelines, etc.).
6、Ensure that timely and consistent communications regarding pro-gram strategy, status and decisions are made within the team and to other stakeholders, including senior management.
Qualifications
1、Education: a Bachelor of Science (e.g. Biology, Chemistry, Engineer-ing, or Pharmacy) required. Advanced degree (Masters or PhD in a sci-entific discipline) is preferred but not required.
2、3-5 years’experience in a Biotech or Pharmaceutical organization in drug development with expertise/knowledge in such functions as Pro-cess Development, Manufacturing and Engineering, Quality, Analytical Chemistry, Formulation, Supply Chain, Regulatory Affairs
3、Self-motivated, and eager to learn; strong ownership, and ability to follow through with direction/tasks; proactive and positive when facing challenges
4、Comfortable working in a fast-paced and dynamic team environ-ment, and can motivate and help others to achieve CMC goals with team efforts
5、Working knowledge of overall drug/biologics development process and familiar with various functional areas and their roles within a bio-tech / pharmaceutical company.
6、Experience in supporting pre-clinical and/or clinical-stage drug de-velopment programs, preferably across different phases (e.g. Phases I–III).
7、Some knowledge of cGMP is desirable
8、Excellent skills of oral and written communications, and sound judgment
9、Ability to multi-task and shift priorities quickly while working under tight deadlines; ability to work under uncertainty
10、Attention to detail, highly organizational, and willingness to learn quickly
11、Good skills in common word processing tools (such as Words, Pow-erPoint, Excel, etc)
12、English proficiency level： passed grade 6 level of English test
13.Title will commensurate with individual’s experience and qualifica-tions