药物分析部助理主任（年薪15~20W)
Key Responsibility
1. Manage a technical group including multiple project groups and teams.
Assure the group/project teams to operate efficiently and effectively with
high quality of services including on-time completion of projects, minimal
analyst’s error and full GMP compliance.
2. Communicate effectively and responsively with clients through email
and tele-, web-, video- conferencing, and assure customer satisfaction.
3. Make project assignment and resource allocations, monitor the project
execution, follow up action plans, and track the project cost.
4. Lead a good functioning team with effective hiring, good supervisory
and leadership skills, ability to motivate, and effective conflict
management.
5. Lead, coach and train the analysts in the team to perform method
development and validation, technology transfer, testing release and
stability samples and OOS/OOT investigation with sound regulatory knowledge
and understanding of GMP.
6. Write, review and approve technical documents including ROA, COA, and
method development and validation reports.
7. Manage the laboratory to be organized, clean, tidy, safe and full
compliance with GMP requirements. Write and review SOPs to standardize the
operations, and to improve operation efficiency and GMP compliance.
8. Perform cost estimate, set up project schedules and assist department
head to draft the quotations.
9. Communicate and interact with cross-functional teams and departments
effectively.
10. Performed all assigned work effectively and efficiently.
Requirements:
1 Must have 5 or more years of industrial experiences in Analytical R&D
2 Must be well familiar with the requirements of the FDA cGMP/GLP
regulations, and ICH guidelines.
M. S. or PhD in Chemistry, Pharmaceutical or related science degrees with
direct experiences and training in analytical chemistry and pharmaceutical
analysis including chromatography
4 Must have supervisory experiences (group leader and above) in
pharmaceutical analytical field.
5 Must have strong communication skills, verbal and written, especially
in English, and interpersonal skills.
6 Experiences in Pharmaceutical formulation support and stability
programs are preferred.
