Fremont, California, United States
15 hours ago
Director Analyte Detection Product Development

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Essential Duties and Responsibilities:

Strategy and Leadership

Define and execute the development strategy for TR-FRET immunoassays to maximize Eurofins DiscoverX’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.

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 requirementsDemonstrates and promotes the company visionRegular attendance and punctualityConducts all activities in a safe and efficient mannerPerforms other duties as assignedOwns accountability and responsibility for delivering to client needs and timelinesAdjusts work hours as needed to meet client deadlines

QualificationsMS/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 preferredExperience drafting qualification/validation reports and SOPs for assay transfer to clients or other departments strongly preferredExperience in managing a team of scientists in assay developmentAbility to independently learn new techniques, solve practical problems, and troubleshoot assaysExperience 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: $175,000 - $220,000/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 optionsLife and disability insurance401(k) with company matchPaid 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.

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