Design Transfer Manager
1 month ago
The Design Transfer Manager will work directly with the VP of R&D Operations to achieve company milestones in disease detection. The successful candidate will assist in planning experimental roadmaps, work collaboratively with other research staff, and optimize and develop assay products to meet departmental and company's objectives focused on Assay Design Transfer. This position will work closely with the Assay Development Group (ADG) and cross-functional product development teams including manufacturing personnel to train on new reagent formulations and coordinate product timelines with other aspects of the product development. You will transfer current assays and molecular technologies to the Alveo's platform.
You Will:
Assist R&D Operations with development and execution of strategic initiatives for the Assay Development R&D group.
Interface on a regular basis with manufacturing personnel to continuously support and successfully complete the Design Transfer of new assays from R&D to Manufacturing. Help manufacturing personnel to understand the scientific aspects of the manufactured product as needed.
Hands-on experience in conducting technical experiments to develop sample-to-answer Molecular Diagnostics Assays and analyze, summarize the experimental data to achieve timely execution of projects.
Author Design Transfer documents inclusive Reagent Formulation protocols and other relevant Process Validation documents, pFMEAs, frozen reagent stability protocols, etc.
Execute according to the approved Study protocols and generate the corresponding reports.
Provide technical expertise to support new molecular Assay Development and modify and improve current molecular assay formulations.
Lead new and current Assay Development and process optimizations, ultimately able to scale up in Manufacturing Operations.
Apply lean six sigma techniques and DOE to accelerate time to market.
Ensure that any new and/or improved reagent products and processes are adequately tested, guard-band studies completed to ensure successful Development and Verification phase and Design Transfer.
Develop raw material specifications and QC specifications as needed.
Help to createproduct FMEAs (Failure Mode and Effects Analysis) and proactively identify, manage and escalate product and project risks and issues to relevant stakeholders, lead development of mitigation and contingency planning.
Motivate other team members by personal example and scientific training to enhance the overall team performance.
Be involved in cross-functional product and process risk assessment, root cause analysis and troubleshooting.
Lead "lessons learned" sessions, share lessons among project leaders and other teams, integrate lessons into existing processes, tools and templates.
Control and propagate an exceptional quality of the documentation and analysis of results that will be submitted to regulatory agencies.
Manage Design Transfer/Reagent Formulations personnel as needed.
Your Background Should Include:
A Ph.D. degree in Biochemistry, Molecular Biology, Microbiology or related field with 5+ years of IVD experience and a proven track record in product development from feasibility to commercialization. For Master's degree candidates a 8+ years track record is desirable.
Expertise in genomics and molecular biology, including principles of nucleic acid chemistry, primer design and technologies for gene target amplification using PCR.
Are familiar with managing complex tasks and delivering innovative solutions.
Excellent understanding of quality systems, regulatory requirements, development and manufacturing processes.
Experience in iso-thermal amplification methods is desirable.
Ability to work successfully across disciplines in a collaborative and cross-functional team environment.
Experience in developing and commercializing diagnostic products in a GLP/GMP environment is required.
Experience working in biosafety level 2 (BSL-2) environment and willingness to work with biohazardous materials.
Experience in design control and product lifecycle management is required.
Previous experience with regulatory submissions, US and OUS is required.
Excellent written and verbal communication skills as well as ability to communicate effectively with scientists and engineers from a wide range of technical backgrounds.
Ability to thrive in a fast-paced cross-functional environment.
Salary range is $109,510 per year - $114,400 per year
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