Senior Technical Transfer Specialist

2 weeks ago

Tucson, United States Apollo Professional Solutions Full time

Job DescriptionDescription:JOB SUMMARY The Senior Technical Transfer Specialist is the overall coordinator between Operations and the Development, Regulatory and Project team while launching of new Assays, Reagents and Bulk materials used in tissue diagnostic tests. This position is responsible for ensuring that all Operations needs are met from a manufacturability, quality, cost and schedule perspective. The application of program management skills, process engineering, lean manufacturing principles and sound scientific rigor are essential to ensure that new Assays, Reagents and Bulk materials are introduced into the existing manufacturing processes. This position ensures 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 to other US or international sites. ResponsibilitiesDefine, understand and communicate manufacturing best practices at the site and communicate minimum requirements to the core project team to ensure manufacturability and scalability of Assays, Reagents and Bulks used in tissue diagnosticsBe the Global Operations project focal and ensure that all Operations stakeholders (Manufacturing, Process Engineering, Validation Engineering, Functional Leads, Quality, Validation, Planning, Purchasing, Procurement and Label Control) needs are understood and communicated through the transfer processActively establish and refine Technology Transfer standard work to continuously improve the transfer process. Actively seeks out, creates and implements new ways to drastically simplify our ways of working within the teamDefine, lead and execute Validation protocols utilizing Good Manufacturing Processes (GMP) and standards for transferred products. Actively define and improve Validation standard work in coordination with the site Validations team to ensure uniformity across the organization.Actively demonstrates project management techniques at an expect level to plan, track and ensure timely completion of transfer projectsUtilizes 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 perspectiveEffectively incorporate manufacturing requirements into development projects to ensure robust technical transfer into operations by providing input at the design stage for design for manufacturingParticipates in and/or leads 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 audiencesMentors, coaches and leads other Technical Transfer Specialists in the execution of projects and provides direct guidance and oversight to how other Technical Transfer Specialists operateDemonstrates the ability lead complex, multinational projects and is able to navigate complex technical, regulatory and business. May be given Project Lead special assignments that require extensive coordination across the globeDemonstrates the ability to work autonomously with minimal guidance or inputOther duties as assigned by management. QUALIFICATIONS 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/EducationBachelor's Degree BS in an Engineering/Engineering Technology or Life Science discipline with 5-8 years of experienceMaster's Degree MS in an Engineering/Engineering Technology or Life Science discipline with 3-5 year of experiencePhD PhD in an Engineering/Engineering Technology or Life Science discipline with 1-3 years Knowledge, Skills and AbilitiesDemonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thoughtStrong 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 - Preferred 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.Meet Your RecruiterNikhil Patelvar isBannerImage = '';// if isBannerImage is empty or undefinedif(isBannerImage''){jQuery('.jb-recruiter-profile-picture').css('left', '0');jQuery('.jb-recruiter-profile-picture').css('bottom', '0');}

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