Senior Technical Transfer Specialist
Senior Technical Transfer Specialist
Large, international medical diagnostics company is growing and to their manufacturing team! Learn from our expansive team of seasoned professionals to expand your skills and career. We offer amazing mountain views and great amenities such as a subsidized cafeteria and onsite gym. This position will be working onsite during the day and start soon. Help cancer patients while developing your professional options.
The Senior Technical Transfer Specialist is the overall coordinator between Operations and the Development, Regulatory and Project team at 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.
• 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.
Education and Experience
Bachelors Degree BS in an Engineering/Engineering Technology or Life Science discipline with 5-8 years of experience
Masters Degree MS in an Engineering/Engineering Technology or Life Science discipline with 3-5 year of experience
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
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.
Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.