Seeking a Technology Transfer Coordinator for a 12 month assignment in McPherson, KS.
This role is supporting the successful execution of technical transfers to and from the companies PEH Pharmaceutical Sciences PharmSci at McPherson from and to other R & D and manufacturing facilities. The coordinator is the liaison between the facilities for introducing of new products small molecules and Biosimilars .
• Responsible for coordinating and smooth execution of day-to-day manufacturing activities of new products
• Contribute with input and assistance from supervisor and experienced engineers/scientists cross functional teams to conduct technology transfer, process optimization, investigations, process scale-up and scale-down studies to support technology transfers in accordance with regulatory requirements.
• Influence both the PharmSci team and the manufacturing plant on setting clear, realistic goals for batch manufacturing.
• Coordinate between the PharmSci and the manufacturing plant to ensure the readiness for - batch manufacture for new products.
• Generate and revise the plant documents including change management, plant documents (Quality tables, monographs, batch records, checklist and etc), SOPs, and mitigate any conflict within the plant as needed and support regulatory activities including authoring applicable CTD sections for product submission.
• Present lab and manufacturing results and technical analysis to internal and external customers.
• May perform other duties as assigned.
• Bachelor’s degree in Science with 2-5 years of experience or MS degree with 0-3 years of relevant experience in Pharmaceutical Science, Chemical/Biochemical/Mechanical Engineering. A background in biopharmaceutical manufacturing and experience and awareness of sterile liquid fill-finish (vials and syringes) would be an advantage.
• Ability to generate and review technical documents such as study protocols, reports and batch records.
• Ability to present and clearly communicate results and technical analysis to technical and non-technical people within and out-side of company.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team environment.
• Must display personal accountability for results, integrity and uncompromising dedication to quality.
For immediate consideration please call 732-246-0215 or email to email@example.com