Apollo Professional Solutions
Technical Transfer Specialist
Apollo Professional Solutions, Tucson, Arizona, United States, 85718
Job Description
Description:JOB SUMMARYThe Technical Transfer Specialist will assist in coordination between Operations and the Development, Regulatory and Project team while launching of new Assays, Reagents and Bulk materials used in tissue diagnostics. This position helps to ensure that all Operations needs are met from a manufacturability, quality, cost and schedule perspective. The application of program management skills, lean manufacturing principles, process engineering and sound scientific rigor are essential to ensure that new Assays, Reagents and Bulk materials are introduced into the existing manufacturing processes. This position help to ensure that the requirements for a minimum viable product are met within Operations and clearly communicates project risks and proposes gap closure plans to eliminate these risks. This position will also support, as needed the transfer of products from site to site or site to supplier within the US.
Responsibilities
Understand and communicate manufacturing best practices at the site and communicate minimum requirements to the core project team to ensure manufacturability and scalabilityBe the Global Operations project focal and ensure that all Operations stakeholders (Manufacturing, Process Engineering, Validations Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing and Label Control) needs are understood and communicated through the transfer processLearn and apply Technology Transfer standard work to continuously improve the transfer processSupport the use of project management techniques to plan, track and ensure timely completion of transfer projectsOvertime, 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 perspectiveLearn and incorporate manufacturing requirements into development projects to ensure robust technical transfer into operations by providing input at the design stage for design for manufacturingExecute Validation protocols with assistance from other Technical Transfer Specialists and utilize Good Manufacturing Processes (GMP) and standards for transferred productsParticipates in cross-functional teams to ensure the needs of the technology transfer project are met. Establishes partnerships across other organizational groups (Lifecycle, Regulatory and other business partners) as requiredTroubleshoots problems. Participates in transfer planning and process updates. Prepares and delivers presentations of project results to others; presents data to larger and more diverse audiencesOther duties as assigned by management.ADDITIONAL RESPONSIBILITIES:Include working with leadership and team members in assisting with various project coordination and planning activities, example: 1) Help maintain the resource and task activity sheets, 2) Schedule and facilitate planning meetings, 3) Monitor and coordinate project assignments & timelines, 4) Identify resource and priority conflicts, 5) Participate in workflow standardization and implement efficiency projects, 6) Help maintain best practices 7) Explore and apply project management tools
QUALIFICATIONSTo 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.
Education Level Education Details
Bachelor's Degree BS in an Engineering/Engineering Technology or Life Science discipline with 1-3 years of experienceMaster's Degree MS in an Engineering/Engineering Technology or Life Science discipline with 0-2 year of experienceKnowledge, Skills and Abilities
Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thoughtBasic understanding of assay, bulk and reagent manufacturing processes and design and the ability to apply scientific method as it relates to productionAdvanced technical writing skills to produce reports and documentsAbility to apply 6 Sigma and Lean Manufacturing Methods during the development phaseAbility to utilize systems such as SAP and ETQ
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
Description:JOB SUMMARYThe Technical Transfer Specialist will assist in coordination between Operations and the Development, Regulatory and Project team while launching of new Assays, Reagents and Bulk materials used in tissue diagnostics. This position helps to ensure that all Operations needs are met from a manufacturability, quality, cost and schedule perspective. The application of program management skills, lean manufacturing principles, process engineering and sound scientific rigor are essential to ensure that new Assays, Reagents and Bulk materials are introduced into the existing manufacturing processes. This position help to ensure that the requirements for a minimum viable product are met within Operations and clearly communicates project risks and proposes gap closure plans to eliminate these risks. This position will also support, as needed the transfer of products from site to site or site to supplier within the US.
Responsibilities
Understand and communicate manufacturing best practices at the site and communicate minimum requirements to the core project team to ensure manufacturability and scalabilityBe the Global Operations project focal and ensure that all Operations stakeholders (Manufacturing, Process Engineering, Validations Engineering, Functional Leads, Quality, Validation, Planning, Procurement, Purchasing and Label Control) needs are understood and communicated through the transfer processLearn and apply Technology Transfer standard work to continuously improve the transfer processSupport the use of project management techniques to plan, track and ensure timely completion of transfer projectsOvertime, 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 perspectiveLearn and incorporate manufacturing requirements into development projects to ensure robust technical transfer into operations by providing input at the design stage for design for manufacturingExecute Validation protocols with assistance from other Technical Transfer Specialists and utilize Good Manufacturing Processes (GMP) and standards for transferred productsParticipates in cross-functional teams to ensure the needs of the technology transfer project are met. Establishes partnerships across other organizational groups (Lifecycle, Regulatory and other business partners) as requiredTroubleshoots problems. Participates in transfer planning and process updates. Prepares and delivers presentations of project results to others; presents data to larger and more diverse audiencesOther duties as assigned by management.ADDITIONAL RESPONSIBILITIES:Include working with leadership and team members in assisting with various project coordination and planning activities, example: 1) Help maintain the resource and task activity sheets, 2) Schedule and facilitate planning meetings, 3) Monitor and coordinate project assignments & timelines, 4) Identify resource and priority conflicts, 5) Participate in workflow standardization and implement efficiency projects, 6) Help maintain best practices 7) Explore and apply project management tools
QUALIFICATIONSTo 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.
Education Level Education Details
Bachelor's Degree BS in an Engineering/Engineering Technology or Life Science discipline with 1-3 years of experienceMaster's Degree MS in an Engineering/Engineering Technology or Life Science discipline with 0-2 year of experienceKnowledge, Skills and Abilities
Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thoughtBasic understanding of assay, bulk and reagent manufacturing processes and design and the ability to apply scientific method as it relates to productionAdvanced technical writing skills to produce reports and documentsAbility to apply 6 Sigma and Lean Manufacturing Methods during the development phaseAbility to utilize systems such as SAP and ETQ
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.