Business Unit Manager - Analyte Detection Product Development

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divh2Business Unit Manager - Analyte Detection Product Development/h2pEurofins 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./ppThe 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./ppIn 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./ppIn 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./ph3Job Description/h3pstrongEssential Duties and Responsibilities:/strong/ppstrongStrategy and Leadership/strong/pulliDefine and execute the development strategy for TR-FRET immunoassays to maximize Eurofins DiscoverXs competitive position./liliBuild, lead, and mentor a high-performing scientific team./liliManage the development and launch of a new portfolio of TR-FRET immuno-assays following a phased stage-gate launch process./liliProvides regular project planning, progress reporting, and concise summaries of experimental results to internal stakeholders and senior management./li/ulpstrongAssay Development Validation/strong/pulliEither 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./liliLead 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./liliEnsures appropriate documentation of assay development history, generates SOPs for kit component manufacturing, and detailed protocols for user manuals to support product launch./li/ulpstrongCross-Functional Collaboration/strong/pulliPartner 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.)/liliCollaborate 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./liliActs as a liaison with external collaborators, partners, or service providers when needed to support assay development or validation./liliProvides cross-functional support to other departments as required./li/ulpstrongCompliance Quality/strong/pulliAdheres to all site employee health and safety (EHS) and IT security requirements/liliDemonstrates and promotes the company vision/liliRegular attendance and punctuality/liliConducts all activities in a safe and efficient manner/liliPerforms other duties as assigned/liliOwns accountability and responsibility for delivering to client needs and timelines/liliAdjusts work hours as needed to meet client deadlines/li/ulh3Qualifications/h3ulliMS/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./liliExperience in TR-FRET assay development, including the use of linkers, experience in TR-FRET based buffer optimization, and experience in antibody screening./liliProficiency in data analysis using GraphPad Prism or equivalent statistical/analytical software./liliExperience developing assays for applications in therapeutic areas such as oncology, neurodegeneration, immunology, or metabolism is highly desirable./liliExperience in mentoring and supervising technical staff is required./liliDemonstrated expertise level knowledge developing immuno-assays with TR-FRET, ELISA, or similar assay format(s)./liliExperience overseeing product development, preferably for an extensive portfolio of similar assays, using a phased stage gate process strongly preferred/liliExperience drafting qualification/validation reports and SOPs for assay transfer to clients or other departments strongly preferred/liliExperience in managing a team of scientists in assay development/liliAbility to independently learn new techniques, solve practical problems, and troubleshoot assays/liliExperience dealing directly with clients in an industry setting (e.g., CRO/client relationship) is highly desirable./liliExperience developing assays for neutralizing antibody detection is a plus/li/ulh3Additional Information/h3pSalary Range: $175,000 - $225,000/yr./ppThe position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed./pulliExcellent full time benefits including comprehensive medical coverage, dental, and vision options/liliLife and disability insurance/lili401(k) with company match/liliPaid vacation and holidays/li/ulpAll your information will be kept confidential according to EEO guidelines./ppEurofins USA Discovery Services is a Disabled and Veteran Equal Employment Opportunity employer./p/div
Location:
Fremont
Category:
Management Occupations

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