Business Unit Manager Analyte Detection Product Development

Job Description

Essential Duties and Responsibilities:

• Define and execute the development strategy for TR-FRET immunoassays to maximize Eurofins Discover
  
  X’s 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.

• 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.

• 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.

• 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.

• 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 Graph Pad 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.

Salary Range: $175,000 - $225,000/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.

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

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