Executive of Manufacturing
杭州奕安济世生物药业有限公司HangzhouUpdate time: May 15,2019
Job Description
- Ph.D. in scientific or engineering discipline with 6-12 years of industry experience or BS/BA in scientific or engineering discipline and 15+ years of industry experience;
- Demonstrated leadership and management experience is required for this position;
- Proven ability to manage staff to achieve high performance; organize and prioritize functional area tasks to achieve results, and accurately assess staff performance;
- Direct involvement in the development and implementation of GMP production process of bio-therapeutics;
- Demonstrates a deep knowledge of all facets of disposable-based biologics manufacturing and operations in a highly regulated environment;
- Exhibits sound judgement, within defined practices and policies, for decision making related to manufacturing compliance, technology development, or obtaining results;
- Provides forward looking recommendations on how department/function can contribute to attain short- and long-term goals; anticipates and seeks to prevent potential road blocks to achieving objectives;
- Demonstrated ability to make sound recommendations and identify potential impacts to senior management across functions;
- Expert knowledge of cGMP requirements and experienced in the development, implementation and maintenance of associated systems;
- Subject matter expert for manufacturing technology and/or process transfer for late stage clinical manufacturing or commercial qualification campaigns;
- Anticipates complex technical issues and proactively develops practical and innovative solutions; proven ability to develop novel processes or approaches within a broad discipline; history of introducing or creating new technologies and concepts;
- Exceptional performance in leadership roles that contributed to the achievement of department/project team objectives; significant contributor to multi-disciplinary and multi-functional teams; mentors and provides career and technical advice to colleagues within the function;
- Exceptional communications skills are required; ability to clearly communicate and accurately present scientific/technical information, both formally and informally, to a diverse set of audiences, including senior management, external partners and the scientific community;
Qualifications:
- Responsible for overseeing the complex day-to-day work of biopharmaceutical drug substance manufacturing in a multi-product clinical and commercial facility to meet goals of quality, productivity and efficiency under cGMP conditions;
- Responsible for providing strategic direction for the manufacture and technical support of mammalian cell-based biotherapeutics for clinical and commercial use;
- Responsible for managing a team of staff to achieve high performance levels and will be accountable for staff effectiveness;
- Responsible for establishing, implementing, and maintaining cGMP systems and processes required to ensure high quality operation and compliance;
- Facilitate communication across functions and with external partners/collaborators;
- Develop and manage functional area capital and expense budgets, and develop models for resource, economic, and/or process analysis;
- Responsible for driving and facilitating continuous process improvement and for developing and maintaining Key Performance Indicators (KPI).
Responsibilities:
If you are interested
please submit your resume to: hr@transcenta.com
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