Assay Transfer Project Manager

Posted 01 Jul 2022

Shanghai, Shanghai - China

Req Id 251888

Details

 

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

 


Position: Assay Transfer Project Manager

 

Your role:

In this Assay Transfer Project Management role, you will coordinate with originating and receiving sites to make sure people are well trained, the specific assay validation master plan is written, and technical methods are transferred on time. All assay transfer work should comply with the global assay validation master plan and ICH guidelines.

 

You will provide clear, routine, and effective communication to key stakeholders in a matrix environment. Work closely to align with global & local project members and stakeholders to drive on-time closure to major timelines.

 

 

The working location is in Shanghai.

 

Brief role description:

 

  • Lead projects to transfer internal assays by collaborating cross-functionally with internal stakeholders
  • Coordinate the overall training plan with originating site, and make sure the people are well trained and qualified for the testing.
  • Proactively identify gaps and/or inefficiencies. Investigate, track and evaluate any technical issues occurring during assay transfer, ensuring that appropriate corrective and preventative actions are identified and implemented.
  • Work with subject matter experts at the originating site(s) to create the training plans for employees at the receiving site.
  • Act as a technical expert on the assays and methods to make and fulfill training plan, supply the necessary technical information and technical support to the key persons.
  • Co-ordinates the procurement of consumables, reagents and materials and takes responsibility for ensuring that the correct materials are available and qualified, as appropriate.
  • Support lab operation team to launch the E-system such as SAP, LIMS, iNet, BuleMountain, etc.
  • Collaborate with cross functional teams to identify project risks and develop mitigation and contingency plans to minimize risk impact throughout the project lifecycle.
  • Ensure projects run smoothly by designing project plans, managing workflow, monitoring program progress, and reporting on key metrics.
  • Sharing metrics, project risks, mitigation/contingency plans to minimize risks, and best practices throughout project.
  • Report back to the Project Leads on a regular basis on progress, roadblocks and course corrections.

 

The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post. Job descriptions will be regularly reviewed to ensure they are an accurate representation of the post.

 

Who you are:

 

Education:

  • Minimum Bachelor’s degree in chemistry, pharmaceutic, biology. Master’s degree or PhD is preferred.
  • PMP certification - Preferred

 

Experience and Requirements:

  • Extensive professional experience 8+ years in pharmaceutic, biology industry
  • Good experience and knowledge of biolab equipment and Quality system within a regulated environment.
  • Knowledge of project management principles including proficient use of project management tools and software to lead complex projects and deliver them to a successful conclusion
  • Be able to build strong working relationships and keep the team focused on the project and manage and resolve challenges in project meetings
  • Excellent listening and communication skills in English (written, verbal and presentation)
  • Good understanding of cGMP’s and GLP’s
  • Strong organizational, time-keeping, and multi-tasking skills; agile mind-set
  • Team Player who is result oriented and strong affinity to transparency

 

HR: 87157

Functional Area: Research & Development


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html

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