Manager of Technology Transfer & Validation Pharmaceutical

Manager of Technology Transfer & Validation - Pharmaceutical

Zhejiang Huahai, a leading vertically integrated generic pharmaceutical company, is the first Chinese company to receive ANDA approval by the US FDA. In a career at Huahai, you will be an important part of a leading research and manufacturing organization in China. We currently have an opening for a Manager position in the Technology Transfer & Validation Department at our Cranbury, NJ facility.

 

Responsibilities:

Manage scale-up and technology transfer from R&D to Manufacturing;

 

Transfer of know-how by providing direction to the operations;

 

Gather and analyze data to ensure consistency with the submission batch and ANDA content;

     

Participate in strategic planning of product development for solid dosage formulation drugs, ensuring alignment with overall business strategy;

 

Participate in regulatory strategy and planning, managing the CMC regulatory submission process.

  

Requirements:

Ph.D. or M.S. in Chemistry, Chemical Engineering, Pharmacy, or related disciplines.

 

5+ years of experience in manufacturing or R&D with exposure to scale-up, validation and manufacturing.

 

Knowledge of cGMP, Generic R&D Development, and FDA regulations.

 

Good leadership and people management skills, sound organizational and project management skills.

 

Travel Requirements: 20% Domestic and International.

 

Chinese writing and speaking is a must.

 

Application:

Send your resume with a cover letter to include salary requirements to Huahai US, Inc. via fax (609) 655 -1658 or email