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Manager, R&D II
Cincinnati | careers-meridianbioscience.icims.com |
About Meridian:
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis.
We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
Job Summary:
Primary role is to be both an R&D leader that manages new product development (NPD) teams and serve as a key technical expert in assay development, specifically in Lateral Flow assays.
Key Duties:
Tasks/Duties/Responsibilities:
• Lead the development of robust study designs (DOEs, statistical strength, complex data analyses, etc.), assay chemistries and formulations for IVD products in a regulated (FDA) environment.
• Take overall responsibility for project deliverables to meet corporate goals.
• Manage and mentor R&D Team Leaders.
• Acts as a subject matter expert in technical area of assay development, reagent development, immunology, microbiology, and related disciplines.
• Evaluate new technologies and platforms and recommend pipeline products.
• Support the creation and submission of FDA correspondence including pre-submissions and 510(k), de novo and PMAs.
• Identify and foster collaborations with KOLs, CROs and collaborators.
• Represent R&D for review and approval of project documents.
• Work cross-functionally to facilitate technology transfer, clinical trials, and the preparation of 510(K) submissions.
• Responsible for leading departmental activities in R&D Sr. Director's absence.
Other duties as assigned:
• Must have the ability to lift 20 pounds of supplies or finished product throughout the workday.
• Must be able to concentrate, analyze and solve complex issues throughout the course of the workday.
• Must be able to wear personal protective equipment (gloves, face shields/safety glasses, latex, or nitrile gloves, etc.).
• Will be required to be fully gowned for performing tasks in a clean room environment.
• Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
• Ability to stand, stoop, reach, push and pull throughout the course of the work shift.
• Experiments may involve materials that are considered potentially biohazardous. Must be able to work with human substances such as blood.
Qualifications:
Minimum Education or Equivalent Experience Required/Preferred:
• Bachelor of Science degree with 12 years of practical experience, or Master of Science degree with 9 years of practical experience, or Ph.D. degree with 7 years of practical experience. A minimum of 3 years of leadership experience.
Competencies Required or preferred:
• Skilled and experienced in the development of IVD assays, specifically in Lateral Flow diagnostic devices.
• Proven track record of product development and launch of IVD products for the North American and EU markets.
• Strong leadership and emotional intelligence.
• Team player, allows others to impact decisions, communicate with cross-functional leads.
• Strong organizational skills, ability to drive change.
• Applies advanced technical principles, theories, and concepts. Contributes to development of new principles and concepts.
• Ability to make sound leadership and technical decisions that have a large impact on business unit achievement.
• Ability to provide expert technically advice to assay teams.
• Ability to correctly assess the technical competitive landscape.
• Ability to translate business unit goals into executable plans understanding technical risks, mitigations, and alternatives.
Required Travel %:
• Up to 15% Travel
*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*
Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis.
We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.
Job Summary:
Primary role is to be both an R&D leader that manages new product development (NPD) teams and serve as a key technical expert in assay development, specifically in Lateral Flow assays.
Key Duties:
Tasks/Duties/Responsibilities:
• Lead the development of robust study designs (DOEs, statistical strength, complex data analyses, etc.), assay chemistries and formulations for IVD products in a regulated (FDA) environment.
• Take overall responsibility for project deliverables to meet corporate goals.
• Manage and mentor R&D Team Leaders.
• Acts as a subject matter expert in technical area of assay development, reagent development, immunology, microbiology, and related disciplines.
• Evaluate new technologies and platforms and recommend pipeline products.
• Support the creation and submission of FDA correspondence including pre-submissions and 510(k), de novo and PMAs.
• Identify and foster collaborations with KOLs, CROs and collaborators.
• Represent R&D for review and approval of project documents.
• Work cross-functionally to facilitate technology transfer, clinical trials, and the preparation of 510(K) submissions.
• Responsible for leading departmental activities in R&D Sr. Director's absence.
Other duties as assigned:
• Must have the ability to lift 20 pounds of supplies or finished product throughout the workday.
• Must be able to concentrate, analyze and solve complex issues throughout the course of the workday.
• Must be able to wear personal protective equipment (gloves, face shields/safety glasses, latex, or nitrile gloves, etc.).
• Will be required to be fully gowned for performing tasks in a clean room environment.
• Must be able to adhere to applicable bio-safety practices when on the manufacturing floor or in laboratories.
• Ability to stand, stoop, reach, push and pull throughout the course of the work shift.
• Experiments may involve materials that are considered potentially biohazardous. Must be able to work with human substances such as blood.
Qualifications:
Minimum Education or Equivalent Experience Required/Preferred:
• Bachelor of Science degree with 12 years of practical experience, or Master of Science degree with 9 years of practical experience, or Ph.D. degree with 7 years of practical experience. A minimum of 3 years of leadership experience.
Competencies Required or preferred:
• Skilled and experienced in the development of IVD assays, specifically in Lateral Flow diagnostic devices.
• Proven track record of product development and launch of IVD products for the North American and EU markets.
• Strong leadership and emotional intelligence.
• Team player, allows others to impact decisions, communicate with cross-functional leads.
• Strong organizational skills, ability to drive change.
• Applies advanced technical principles, theories, and concepts. Contributes to development of new principles and concepts.
• Ability to make sound leadership and technical decisions that have a large impact on business unit achievement.
• Ability to provide expert technically advice to assay teams.
• Ability to correctly assess the technical competitive landscape.
• Ability to translate business unit goals into executable plans understanding technical risks, mitigations, and alternatives.
Required Travel %:
• Up to 15% Travel
*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*
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