Formulation Director- GMP Support group ( Senior Principal Scientist)
- Lead a supportive team, which covers document management, equipment/instrument management, equipment calibrations and maintenance, facility cleaning, and supporting CT manufacturing.
- Organize, instruct and supervise the IQ/OQ/PQ activities for new equipments and GMP facilities.
- Cooperate with QA department regarding to equipment and facility qualification and product quality related issues. Initiate SOP writing and revision.
- Coordinate with Engineering Department for equipment installation, GMP facility modification and expansion.
- Coordinate with Procurement, Financial, Import/Export, EHS and Business Development departments for equipment purchasing, tech service and other issues.
- Lead the department scheduling program to ensure the smooth operations of CT manufacturing in GMP pilot area.
- Provide technical support to the project teams, and train staff for new technologies and new equipments.
Scope of the job
- Be expected to perform the assigned job functions independently with limited supervision from upper management.
- Must be able to work with multiple projects and prioritize the workload to meet the pre-determined timelines.
- Individuals will be expected to accomplish their work assignments by interacting closely with peers and by developing cooperative working relationships with other personnel inside the company; communicate effectively with customers when needed and instructed.
Good communication, open exchange of information and project teamwork will be required in order to meet job performance. There must be strong recognition of high performance standards and of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.
Core business/Functional skills and education
- MS or Ph.D. degree in Pharmaceutics or other directly-related science discipline with experience or training in formulation development and manufacturing.
- Must be proficient with the requirements of the s-FDA/US-FDA/ EMEA cGMP regulations, ICH guidelines as well as drug development process.
- Prior experience in working in GMP environment. Must be able to work in a team-oriented manner in order to accomplish performance objectives.
- Problem solving ability and adept handling of formulation teams is also required.
- Strong technical expertise in formulation development and CT manufacturing.
- Strong communication skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.