Tech Transfer Specialist | cGMP, FDA | Noord-Holland
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical and Biotechnology organisation, based in Noord-Holland Netherlands.
(1) designing manufacturing procedures for new or modified products,
(2) planning, coordination, and oversight of the manufacture of development, product validation batches, and cleaning validation/verification studies as needed,
(3) providing technical support to manufacturing operations as assigned by Project Manager.
He/she is effectively the linking-pin between MS&T and Manufacturing department. The Technology Transfer Officer must have outstanding verbal/written communication and inter-personal skills because this position interacts directly with manufacturing plant operators and project teams.
• Orders required project-specific materials, co-prepares master batch records, product specification files, and testing plans for the manufacture of development, validation and launch batches, as required.
• Communicates plant issues and tasks with the project team with respect to readiness for process scale up, new equipment and procedures, equipment and process validation and manufacturing of batches.
• Serves as the plant focal point for channeling all manufacturing related questions between MST and Production plant, and regularly supervise/participate in manufacturing operations.
As required, provide or review various technology transfer documentation, and leads/organizes production deviation investigations.
• Evaluate new technologies to improve/optimize commercial manufacturing processes
• May fulfill other jobs/responsibilities
• Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment
• Fluent command of the English language and at least basic command of the Dutch language.
• 1-3 years’ experience with product development, process scale up, or technology transfer assignments that demonstrates the tenacity to see projects through to completion; analytical skills necessary for problem solving issues as they arise
• Knowledge of parenteral product development, manufacturing processes, validation, cGMP’s and FDA regulations for the Pharmaceutical Industry
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
The Company
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!Role Description
The Tech Transfer Specialist is responsible for assisting with the transfer of manufacturing processes and/or technology from R&D to the plant manufacturing plant. He/she participates in(1) designing manufacturing procedures for new or modified products,
(2) planning, coordination, and oversight of the manufacture of development, product validation batches, and cleaning validation/verification studies as needed,
(3) providing technical support to manufacturing operations as assigned by Project Manager.
He/she is effectively the linking-pin between MS&T and Manufacturing department. The Technology Transfer Officer must have outstanding verbal/written communication and inter-personal skills because this position interacts directly with manufacturing plant operators and project teams.
Responsibilities
• Coordinates the preparation for the manufacture of the new products to ensure smooth preparations for and executions of batch manufacturing.• Orders required project-specific materials, co-prepares master batch records, product specification files, and testing plans for the manufacture of development, validation and launch batches, as required.
• Communicates plant issues and tasks with the project team with respect to readiness for process scale up, new equipment and procedures, equipment and process validation and manufacturing of batches.
• Serves as the plant focal point for channeling all manufacturing related questions between MST and Production plant, and regularly supervise/participate in manufacturing operations.
As required, provide or review various technology transfer documentation, and leads/organizes production deviation investigations.
• Evaluate new technologies to improve/optimize commercial manufacturing processes
• May fulfill other jobs/responsibilities
Requirements
• Minimum of a Master’s degree in pharmacy, engineering, or equivalent experience• Must possess good interpersonal skills to establish effective working relationships that are critical in a team environment
• Fluent command of the English language and at least basic command of the Dutch language.
• 1-3 years’ experience with product development, process scale up, or technology transfer assignments that demonstrates the tenacity to see projects through to completion; analytical skills necessary for problem solving issues as they arise
• Knowledge of parenteral product development, manufacturing processes, validation, cGMP’s and FDA regulations for the Pharmaceutical Industry
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Cees Roffelsen.
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