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Job DescriptionNew hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, this role will be temporarily based in a and exact timing of the departmental move to Rahway, NJ will be communicated at a future date.Translational Molecular Biomarkers Senior Principal Scientist- Clinical Flow Cytometry (R6)Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and consumer health products, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.We are currently recruiting for a Senior Principal Scientist to direct the GxP Clinical Cytometry group within the Translational Molecular Biomarkers (TMB) organization. This key individual must possess scientific excellence in the field of Flow Cytometry, discovery biology, clinical biomarkers, clinical development, leadership, management skills to direct a group of Clinical Flow Cytometry experts, and excellent communication skills. This individual will have a critical strategic and tactical role in overseeing the development, validation, and implementation of Flow Cytometry-based biomarkers, as well as generation of biomarker data for our Company's early and late phase clinical trials. This will be done in close collaboration with Discovery, Translational and Clinical teams across several therapeutic areas, with an emphasis in Oncology and Immunology. Our Company has a strong history and legacy for the early, strategic, and successful use of biomarkers in clinical development. The Senior Principal Scientist-Clinical Flow Cytometry will further cement our position in this key area for our Company by ensuring that biomarkers are used in a meaningful, strategic and resource-conscious way to inform critical decisions such as dose selection, program prioritization, go, no/go decisions.This Kenilworth-based position will report into the Executive Director of Translational Molecular Biomarkers-Genome and Biomarker Sciences (GBx). Beyond this, the incumbent will operate in a highly collaborative and matrixed environment, partnering with peers and stakeholders on site and at other locations in Boston, San Francisco, New Jersey, Pennsylvania and globally.Responsibilities:Direct the Clinical Cytometry Laboratory within TMB.
Oversee Cytometry-based assay development, validation, and deployment for our Company's clinical trial across all therapeutic areas with an emphasis in Oncology and Immunology.
Oversee the generation of clinical data for our Company's clinical trials.
Serve as a subject matter expert in Cytometry and other cell-based assays development and fit-for-purpose validation.
Interface with scientists in Discovery and Clinical Development in the execution of biomarker strategies.
Interface with CROs and external laboratories for the transfer, validation, and implementation of Flow Cytometry assays.
Familiar with GxP, CLIA, CAP guidelines and regulations.
Train and guide TMB staff in Cytometry-based assay development and validation.
Strategic planning for determination of mission and direction of the Flow Cytometry Laboratory.
Specific responsibilities:Oversee the development, performance, and monitoring of Quality Control, Quality Assurance and Quality Improvement procedures.
Maintain close communication with our Company's Translational network to address any technical or laboratory issue related to Flow Cytometry assays.
Write memos, final reports and publications summarizing data.
Write, update, and provide training on laboratory SOPs.
Stay up to date of new technologies/methodologies/test and recommend implementation of new technology within the laboratory.
Budget planning and adherence, payment of invoices, generation of Statement of Works (SOW) and POs for assay validations, etc.
Oversee day-to-day Flow Cytometry Laboratory work performance to determine staff resource utilization, effective management of workload, equipment maintenance.
Requirements:Minimum required education:A minimum of a PhD in Biological Sciences or related field with 10+ years of experience in translational sciences with research in one or more aspects of biomarkers.
Required experience:A minimum of 10 years of direct experience in Flow Cytometry-based assay development and validation.
Proven track-record in successfully managing and leading a team of scientists.
Deep knowledge and expertise on the role of translational research/medicine and clinical biomarkers in drug development, including the regulatory landscape.
Strong knowledge of drug development, including biology, clinical development. Working knowledge of diagnostic development.
Demonstrated ability to work in a highly matrixed organization, with multiple stakeholders.
Contributions to external scientific community through presentations and participation in appropriate scientific conferences and through other avenues such as journal articles, book chapters.
Excellent verbal and written communication skills.
Ability to execute within a matrixed organization.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.Who we are …We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.What we look for …Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.NOTICE FOR INTERNAL APPLICANTSIn accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.For more information about personal rights under Equal Employment Opportunity, visit:EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)EEOC GINA SupplementOFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf)Pay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:Domestic/InternationalVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Flex Time, Remote Work, Work WeekShift:Valid Driving License:NoHazardous Material(s):Number of Openings:1Requisition ID: R162694
