BioFire Diagnostics, LLC is seeking a Technology Transfer Project Manager to join our team! The Product Transfer group is expanding and we need a great individual ready to work closely with all departments to transfer new products from R&D to manufacturing.
The Technology Transfer Project Manager is the point of reference for internal technical expertise and provides technical support for improvements to existing products/processes and helps transfer new products/processes to both instrument and reagent manufacturing.
Qualified individual will be responsible for coordinating all efforts involved in the transfer of new chemistry products, instrument products, and manufacturing equipment from R&D into reagent and/or instrument manufacturing. The Technology Transfer Project Manager will present reports and the status of the work packages, communicate technical aspects of transfer and Quality needs to those not familiar with the process, and work closely with the Program/Project Managers (P/PM) to establish project transfer timelines and ensure that products/processes are compliant with company quality standards.
Applicants must have a BS or MS in the life sciences, engineering, or equivalent technical field. Experience in manufacturing, mechanical engineering, or molecular biology/microbiology in an industrial setting a plus. In addition to the basic education requirements, a minimum of 3 years of work experience is required as well as a minimum of 3 years of experience working in ISO 9001/13485 and/or cGMP/cGLP compliant environment. Higher level graduate level education may be substituted for work experience. Knowledge of FDA and other relevant regulatory environments is a plus. Experience in a life science related industry and/or PCR is a plus.
Required skills include:
Proficient in Microsoft Office program suite
Strong documentation practices, organizational skills, and attention to detail
Strong verbal and written communication skills
Excellent interpersonal skills
Ability to work collaboratively and independently
Strong decision making skills
Ability to elicit cooperation from a wide variety of sources, including many departments within the company and work as a team player
Ability to effectively prioritize and execute tasks in fast-paced environment
Ability to problem solve
Skills desired but not required:
Statistical and data analysis
Familiarity with following software packages: Visio, Perforce, Solidworks, EPDM, and MS Project
Familiarity with project management knowledge and skills