CMC Technical Development Leader

3 weeks ago


Shanghai, China Boehringer Ingelheim Full time

About Animal Health Business
As the leading animal health company in China, we have extensive business coverage from the full value chain in R&D, production to sales and a diversified product portfolio covering swine, poultry, pets, cattle vaccines and medicines. We are always "in China and for China". We've pioneered many game-changers in the veterinary medicine, and we're looking to our customers' needs to guide us into the future.


Job Responsibilities:

Formulate a scientifically sound and business driven technical strategy, in line with overall project strategy, Global Project Leader (GPL), functional experts and managers. Prepare and present information related to the technical development aspects as requested at internal governance meetings and external health authority meetings.Implement and manage the technical development strategic plan for assigned projects (internal or external) following the respective Development Guide, Ensure all critical project milestones are met while maintaining a high level of quality.Proactive communication of overall project strategy, key issues/risk and any other critical topics in a timely manner to the Technical Development Team (TDT), appropriate management level (GPL and line management) and relevant stakeholders. This will be guided by development head and global experts. Identify the strategic risks related to the technical development plan, regularly conduct risk assessments, and ensures development of mitigation strategies and contingency options. This will be guided by development head and global experts.


Job Requirements:
Education Requirements:

. in Science with 5+ years of Animal or Human Health product development experience.. in Science with 8+ years of Animal or Human Health product development experience.. in Science with 10+ years of Animal or Human Health product development experience.

Job Expertise:

At least 5 years' experience in pharmaceutical drug development or biological development. Be familiar with GMP design and process. Excellent knowledge of development, . the position requires expertise in the development of finished products including a high-level understanding of the regulatory, quality and clinical requirements. It will require the ability to coordinate the efforts of diverse resources towards achieving a common deliverable. Understanding both the concepts and constraints of finished product development as well as the existing capabilities in manufacturing will be very useful in optimizing the technical development timeline. Ideally, involved in more than one product developments which resulted in successful products on the market and/or multiple patents filed.

Professional Skills and Competencies:

Position requires significant experience in Animal or Human Health product development. The following attributes will be critical for this position:Technical understanding of process development and good technical problem-solving skills.Familiarity with relevant health regulatory agency requirements for new drug product submissions, ideally animal health related experience. Such as, GXP.Appropriate alignment for regulatory and quality requirements. Good organizational skills and familiarity with developing biological vaccine product development timelines.Capability to deal with a variety of challenging matters including setbacks and failures. Fluency in Chinese and English is mandatory. 

Experience and Leadership requirements:

Strong interpersonal skills and communication skills.Skilled in conflict resolution and negotiation.Strong decision-making skills with the ability to solve problems. Transparent in communication of failures. Positive attitude and willingness to take risks.Ability to challenge teams and functional heads and able to recommend innovative alternatives.

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