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2 great Director level positions in Biopharma field in Shanghai. Please
contact Echo directly if interested.
Cell: +186 2160 0641
E-mail:[email protected] com
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1. Director of Bioassay and Biological Characterization
Responsibilities:
• Lead bioassay development activities. Accountable for
bioassay applications for early and late stage development programs,
bioassay qualification/validation, troubleshooting, direct supervision of
scientific staff, and strong collaboration with partner organizations.
• Develop talent, inspire innovation and operational
excellence and foster a continuous learning environment.
• Draft and review regulatory submissions including INDs and
BLAs.
• The applicant should be an effective communicator of ideas
, project goals and results to cross-functional team members.
• Candidates should be self-motivated and organized,
familiar with the relevant literature.
• The applicant will make decisions affecting direction of
project and for ensuring project timelines are met.
• Strong knowledge of GMPs. Regulatory audit and inspection
experience preferred.
• Hands-on technical leadership of all aspects of potency
assay development.
• Direct scientists in the initiation and execution of
laboratory experimentation, considering economic, regulatory and safety
factors.
Qualifications:
• Requires a Ph.D. in Cell Biology, Molecular Biology, or
Immunology and 5-10+ years of relevant experience that demonstrates an
expertise in potency assay development and scientific accomplishments.
2. Sr. Director of Biologics Operation
JOB SUMMARY
•Responsible for operations management of Biologics Shanghai
•Responsible for coordinate operations activities of Biologics sites,
including Shanghai, Wuxi and Suzhou
•Represent Biologics at Corporate level operations meetings
•Support functional teams of Biologics Shanghai, including Discovery,
Process Development, Project Management, HR, QA, and Process Engineering
•Ensure Biologics Operations comply meet corporate and regulatory
requirements
•Ensures Management is well informed on progress of the Operations
activities
ESSENTIAL DUTIES AND Responsibilities
•Responsible for managing operations for Biologics Shanghai, including
◦Daily operations
◦LSS
◦EHS
◦CAPEX
◦5S labs
◦Space management
•Represent Biologics Shanghai to collaborate with Corporate OUs
•Support functional teams of Biologics Shanghai, including Discovery,
Process Development, PM, HR, QA and Process Engineering
•Support the establishment and operations of Biologics GMP facilities
•Develop Biologics Operations team to meet the growth of Biologics
OTHER DUTIES AND responsibilities
•Other duties assigned by SVP
KNOWLEDGE SKILLS AND Abilities
Master and above degree in pharmaceutics, biology, engineering, business
administration
More than 10 years of operations management in pharmaceutical and
biopharmaceutical industry
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