Process Development Associate II, Tech Transfer & Logistics (TT&L)

Location
Working from home
Posted
Jul 16, 2021
Ref
R950
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a Process Development Associate II to work in the Technology Transfer & Logistics (TT&L) group within Preclinical Manufacturing and Process Development. The TT&L group is responsible for leading production process transfer of product candidates to support clinical manufacturing as well as managing and coordinating a wide variety of departmental business operations. The ideal candidate should demonstrate initiative in accomplishing independent projects while also participating effectively as a member and/or leader of teams. The candidate will be responsible for driving assigned projects to completion with timeline, quality, and budgetary constraints using service-oriented project management tools and knowledge in the drug development industry. They will develop action plans, construct and manage timelines, cultivate productive relationships with internal and external customers, and facilitate troubleshooting/resolution of technology transfer issues or challenges. The candidate should demonstrate resourcefulness through proactive behavior and effective value prioritization of tasks. They will be expected to communicate effectively with all functions and levels within the organization and exemplify solid interpersonal skills with a service-oriented mindset, while leveraging technical experience and understanding. The candidate should demonstrate innovative thinking towards generating new ideas/techniques, strong leadership and poise in approach to work, and utilize subject matter expertise in area of specialization to execute projects with minimal guidance, while seeking to deliver the most valued, innovative, and efficient operational support for all stakeholders.

A Typical Day in the Role Might Look Like:

The individual will be primarily involved in process transfer activities during all stages of pre-launch drug development. The candidate will be relied on to:
  • Lead teams of cross-functional subject matter experts to complete process transfer of developed production processes to clinical manufacturing facilities. Work to ensure the successful start-up of manufacturing production campaigns. Engage team cooperation to facilitate resolution of cross-functional issues and/or provide value-adding solutions.
  • Ensure effective, accurate and timely communication across functional areas within project/program teams. Serve as a primary contact for management within and outside team regarding progress on project/program goals. Must be able to manage and adapt to rapidly evolving project priorities and timelines.
  • Build and maintain detailed timelines for development and transfer activities related to early or late-stage candidate production processes. Ensure official process related documentation is generated, reviewed, and delivered through Regeneron quality systems in a timely fashion.
  • Organize and run meetings and communication to enable effective knowledge exchange between departments. Ensure alignment across relevant functions and smooth transitions across pipeline stages. Responsible for communicating plans to cross-functional departments and groups.
  • Manage recurring and ad-hoc technical teams to troubleshoot technical issues, implement new technologies, systems, or tools, and/or brainstorm and implement improved business processes.
  • May be asked to maintain and/or enhance and develop existing modeling or data visualization software tools to improve analyses.
  • Contribute to continuous improvement efforts where applicable to streamline and maintain departmental process logistics, systems and tools, and/or reference materials and guides. Set up systems and processes to ensure exceptional service for all stakeholders across projects, programs, and/or initiatives.


This Job May Be For You If You Have:

BS in Chemical Engineering, Biochemical Engineering, Bioengineering, or Biotechnology with an interest in Operations, Project Management, and Business.
  • Has 0-2 years work experience in the biotechnology or pharmaceutical industry. Strong customer service skills and orientation needed.
  • Possesses a good ability to facilitate team collaboration and design effective business processes. Has experience leading and working with teams towards common project goals. Promotes teamwork and the exchange of ideas and information in all directions. Anticipates and proactively adjusts for problems and roadblocks. Understands how/when to provide necessary feedback and to whom to address/confront conflicts as they arise.
  • Possesses a good knowledge of research principles, theories, design and implementation. Prior experience performing experimentation in a biopharmaceutical process development laboratory is preferred.
  • Demonstrates ability and initiative to use knowledge and experience to solve problems in area of specialty. Commands necessary courage to confront issues head on to advance projects efficiently and effectively.
  • Has an understanding of the relationships among different fields as they apply to drug discovery and the vision to recognize how to effectively bridge key issues back to the department to drive efficient progress.
  • Possesses excellent communication, organizational, managerial, analytical, computer, and technical writing skills.


In order to receive consideration, please make sure your GPA is clearly listed on your resume.