Overview
On Site
Full Time
Skills
Program Management
MVP
Scalability
Global Operations
Process Engineering
Procurement
Purchasing
Design For Manufacturability
GMP
Technology Transfer
Partnership
Presentations
Management
Project Coordination
Workflow
Project Management
Life Sciences
Assays
Manufacturing
Scientific Research
Technical Writing
Six Sigma
Lean Manufacturing
SAP
SAP BASIS
Law
IT Service Management
Innovation
Collaboration
Recruiting
Insurance
Finance
Professional Development
Training
Leadership
CompTIA
Customer Service
Career Counseling
Oracle Application Express
Apex
Job Details
Job#: 2074652
Job Description:
JOB SUMMARY
The 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 scalability
Be 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 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 (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
Other 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
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
Education LevelEducation Details
Bachelors DegreeBS in an Engineering/Engineering Technology or Life Science discipline with 1-3 years of experience
Masters DegreeMS 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
EEO Employer
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 or .
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.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Job Description:
JOB SUMMARY
The 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 scalability
Be 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 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 (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
Other 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
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
Education LevelEducation Details
Bachelors DegreeBS in an Engineering/Engineering Technology or Life Science discipline with 1-3 years of experience
Masters DegreeMS 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
EEO Employer
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 or .
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.
Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.