Aerospace, manufacturing, engineering, biotech and pharmaceutical, and more.
Apollo Professional Solutionshttps://www.apollopros.com/wp-content/uploads/2022/05/ApolloLogo600.pnghttps://www.apollopros.comhttps://www.apollopros.comUSD3441HOURtrue
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.
Responsibilities
Define, 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 diagnostics
Be 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 process
Actively 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 team
Define, 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 projects
Utilizes 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
Effectively incorporate manufacturing requirements into development projects to ensure robust technical transfer into operations by providing input at the design stage for design for manufacturing
Participates 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 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
Mentors, coaches and leads other Technical Transfer Specialists in the execution of projects and provides direct guidance and oversight to how other Technical Transfer Specialists operate
Demonstrates 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 globe
Demonstrates the ability to work autonomously with minimal guidance or input
Other 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/Education
Bachelor's Degree BS in an Engineering/Engineering Technology or Life Science discipline with 5-8 years of experience
Master's Degree MS in an Engineering/Engineering Technology or Life Science discipline with 3-5 year of experience
PhD PhD in an Engineering/Engineering Technology or Life Science discipline with 1-3 years
Knowledge, Skills and Abilities
Demonstrates potential for technical proficiency, scientific creativity, collaboration with others, and independent thought
Strong 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 - 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.
