Process Development Associate II/ Engineer I Tech Transfer & Logistics
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases . Summary. We are seeking a Process Development Associate/Engineer to work in the Technology Transfer & Logistics group within Pre-Clinical Manufacturing and Process Development. The TT&L group is primarily responsiblefor leading production process transfer of protein candidates to Clinical Manufacturing as well as managing departmental business operations. The ideal candidate should demonstrate initiative in accomplishing independent projects while also participating effectively as a member of teams. The candidate will be responsible for driving assigned projects to completion with timeline, quality, and budgetary constraints using program management tools and knowledge in the drug development industry. He/she 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. He/she will be expected to communicate effectively with all functions and levels within the organization, exemplify solid interpersonal skills while leveraging prior 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 . Responsibilities. The individual will be primarily involved in early or late stage clinically/commercially-enabling process transfer activities. 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 for knowledge exchange between departments. Ensure alignment across relevant functions and smooth transitions across pipeline stages. Responsible for communicating plans to external groups -Manage recurring and ad-hoc technical teams to troubleshoot technical issues and/or brainstorm and implement improved business processes -Conduct modeling work when appropriate to help drive key process development decisions. 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 departmental process logistics . Requirements. BS or MS in Chemical Engineering, Biochemical Engineering, Bioengineering or Biotechnology with an interest in Operations, Project Management and Business -Has 0-5 years work experience in the biotechnology or pharmaceutical industry. Strong customer service skills and orientation needed -Possesses a good ability to facilitate team cooperation 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. 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 highly recommended -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 -Knowledge of costs and/or production . This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business . To all agencies . Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid . Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.