工作地点：烟台
年薪：面议
Responsibilities:
This VP position reports to President and will oversee and manage Biologics GMP
manufacturing (media preparation, chemical synthesis, cell culture, ADC,purification and fill/finish manufacturing). Manage the manufacturing operations ofADC, cell culture, downstream processing, and fill finish in a multiple product facility.
- Allocate resources to achieve objectives and ensure the production schedules are
met.
- Ensure critical manufacturing documentation are prepared timely such as BPR’s,
SOP’s and specifications.
- Oversee raw material inventory, cleaning and gowning management to ensure
compliance with current Good Manufacturing Practices (cGMP), policies and safety
practice.
-Provide technical expertise for manufacturing deviations, change control, CAPA
and assist QC OOS investigations by working in concert with Quality Assurance to
ensure proper disposition of affected materials.
-Support operational budgets, cost controls and resource planning to meet production objectives.
- Developing staff capabilities, creating a culture of safety, maintain training objectives, compliance and collaboration while implementing process improvements where applicable.
Requirements:
- Advanced degree in a scientific discipline (i.e. Chemistry, biology, Chemical or
Pharmacuetical Engineering).
- More than 10 years’ biotech manufacturing/development environment experience and more than 8 years’ experience in supervising position.
-In-depth knowledge in drug substance and/or drug product manufacturing and
engineering aspects of larger scale operations.
-Hands on GMP experience with all phases of drug development and manufacturing,
as well as in-depth knowledge and full understanding of GMP requirements.
-Strong leadership and excellent verbal & written communication skills
-Directly managing biologics manufacturing group of 50 plus employees.
-Well-versed in technical and cGMP knowledge to support Regulatory, Quality, Validation, Compliance, Research/Development and Manufacturing requirements for regulatory agency approval.
-Fluent in English and Chinese (verbal, reading and writing)