Senior Director Analyte Detection Product Development

Essential Duties and Responsibilities:

Strategy and Leadership

• Define and execute the development strategy for TR-FRET immunoassays to maximize Eurofins DiscoverXs competitive position.
• Build lead and mentor a high-performing scientific team.
• Manage the development and launch of a new portfolio of TR-FRET immuno-assays following a phased stage-gate launch process.
• Provides regular project planning progress reporting and concise summaries of experimental results to internal stakeholders and senior management.

Assay Development & Validation

• Either individually conduct or oversee development troubleshooting and validation of new TR-FRET assays for the detection of specific analytes in cell culture medium cell lysates blood etc. Works diligently to meet product development goals set by the management team.
• Lead assay validation exercises to determine LLOQ LLOD Z spike recovery etc. as well as appropriate benchmarking exercises against competitor products to generate data to support marketing activities.
• Ensures appropriate documentation of assay development history generates SOPs for kit component manufacturing and detailed protocols for user manuals to support product launch.

Cross-Functional Collaboration

• Partner with the marketing team to define the scope of the portfolio offering product release specifications data package requirements and product release schedule. Provide validation data in formats suitable for inclusion in marketing materials scientific presentations (posters webinars white papers etc.)
• Collaborate with the manufacturing team to identify and qualify appropriate vendors for critical kit components and train internal manufacturing and QC teams to support kit assembly and component QC.
• Acts as a liaison with external collaborators partners or service providers when needed to support assay development or validation.
• Provides cross-functional support to other departments as required.

Compliance & Quality

• Adheres to all site employee health and safety (EHS) and IT security requirements
• Demonstrates and promotes the company vision
• Regular attendance and punctuality
• Conducts all activities in a safe and efficient manner
• Performs other duties as assigned
• Owns accountability and responsibility for delivering to client needs and timelines
• Adjusts work hours as needed to meet client deadlines

Qualifications :

• MS/PhD or equivalent experience in cell biology biochemistry or related discipline with a minimum of 7 years of industrial experience in assay and product development. Broad scientific knowledge in cell signaling pathways protein function and immunoassay theory. Experience in antibody conjugation immunoassay development and buffer optimization.

• Experience in TR-FRET assay development including the use of linkers experience in TR-FRET based buffer optimization and experience in antibody screening.
• Proficiency in data analysis using GraphPad Prism or equivalent statistical/analytical software.
• Experience developing assays for applications in therapeutic areas such as oncology neurodegeneration immunology or metabolism is highly desirable.
• Experience in mentoring and supervising technical staff is required.
• Demonstrated expertise level knowledge developing immuno-assays with TR-FRET ELISA or similar assay format(s).
• Experience overseeing product development preferably for an extensive portfolio of similar assays using a phased stage gate process strongly preferred
• Experience drafting qualification/validation reports and SOPs for assay transfer to clients or other departments strongly preferred
• Experience in managing a team of scientists in assay development
• Ability to independently learn new techniques solve practical problems and troubleshoot assays
• Experience dealing directly with clients in an industry setting (e.g. CRO/client relationship) is highly desirable.
• Experience developing assays for neutralizing antibody detection is a plus
   

Additional Information :

Salary Range: $175000 - $225000/yr. 

The position is full-time Monday-Friday 8 a.m.-5 p.m. with overtime as needed. 

• Excellent full time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

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All your information will be kept confidential according to EEO guidelines.

Eurofins USA Discovery Services is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time