Global Operations Project FocalUnderstand and communicate manufacturing best practices at the site and communicate minimum requirements to the core project team to ensure manufacturability and scalability. Be the Global Operations project focal and ensure that all Operations stakeholders needs are understood and communicated through the transfer process. Learn and apply Technology Transfer standard work to continuously improve the transfer process. Support the use of project management techniques to plan, track and ensure timely completion of transfer projects.
Overtime, develop an expertise in site manufacturing processes to promote, train and improve GMP within the site to ensure transfer activity is successful from cost, quality and delivery perspective. Learn and incorporate manufacturing requirements into development projects to ensure robust technical transfer into operations by providing input at the design stage for design for manufacturing. Execute Validation protocols with assistance from other Technical Transfer Specialists and utilize Good Manufacturing Processes (GMP) and standards for transferred products. Participates in cross-functional teams to ensure the needs of the technology transfer project are met.
Establishes partnerships across other organizational groups as required. Troubleshoots problems. Participates in transfer planning and process updates. Prepares and delivers presentations of project results to others; presents data to larger and more diverse audiences.
Other duties as assigned by management.Additional responsibilities include working with leadership and team members in assisting with various project coordination and planning activities, such as helping maintain the resource and task activity sheets, scheduling and facilitating planning meetings, monitoring and coordinating project assignments & timelines, identifying resource and priority conflicts, participating in workflow standardization and implementing efficiency projects, helping maintain best practices, and exploring and applying project management tools.To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.Formal Training/Education:Education Level:Bachelor's Degree BS in an Engineering/Engineering Technology or Life Science discipline with 1-3 years of experience.Master's Degree MS in an Engineering/Engineering Technology or Life Science discipline with 0-2 year of experience.Knowledge, Skills and Abilities:Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought.Basic understanding of assay, bulk and reagent manufacturing processes and design and the ability to apply scientific method as it relates to production.Advanced technical writing skills to produce reports and documents.Ability to apply 6 Sigma and Lean Manufacturing Methods during the development phase.Ability to utilize systems such as SAP and ETQ.