Senior Scientist Biologics amp Vaccine Analytics

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Job DescriptionnnNew hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in customer facing commercial or research based roles, will be required to be fully vaccinated as a condition of employment.nu00a0nPosition Description:nOur Biologics and Vaccines Analytics (BVA) team is seeking a Senior Scientist. Biologics and Vaccines Analytics (BVA) is a group within our Manufacturing Division, which manages commercialization of vaccines and biologics throughout launch to supply. BVA provides analytical development, optimization, and promotion through a product's life cycle.nActivities within this dynamic environment include interfacing with a global network of product manufacturing and testing, collaborating with product development groups within our Manufacturing and our Research and Development divisions, oversight of analytical control organizations, managing assay validation and transfer activities, as well as Biologics License Application preparation.nnAdditional TasksnnnDirect an analytical working group for late-stage/commercial biologics program.nnnCollaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in the area of large molecule (biologics) analyticsnnnCoordinate with analytical and process development groups to prepare for and coordinate analytical trouble-shooting, validation and technology transfers between our Company, external partners and CMO/CROs.nnnContribute to and coordinate analytical activities across multiple projects.nnnGuide cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of late-stage activities (Phase III clinical trials, launch, life-cycle management) for novel biologics.nnnSteer teams of subject matter experts to develop and optimize biochemical, immuno-chemical and chromatography-based analytical methods.nnnPrepare and execute analytical method transfers and assay method validations, including authoring and coordinating review of protocols and reports.nnnProvide on-going support to internal staff and external partners to resolve analytical issues and trouble-shooting.nnnDevelop and execute critical reagent protocols for qualification and stability studies.nnnPerform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods.nnnCoordinate analytical issue resolution via subject matter experts within the global biologics networks.nnnnRequired Qualifications:nEducation and Experience:nnnBachelor's of Science (Biology, Chemistry, Biochemistry or related sciences) AND five (5) years of working in a related role ORu00a0nnnMaster's of Science AND three (3) years of working in a related role , ORu00a0nnnPh.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science plus two (2) years of working in a related role.nnnnKnowledge and Skills:nnnMinimum two (2) years of large molecule (vaccine or biologics) method development, validation, or project managementnnnMinimum of two (2) years of working knowledge of a GMP laboratory environmentnnnAbility to work within and direct Cross-Functional Teamu00a0nnnLearn new techniques and multi-task with minimal supervisionnnnDetailed oriented with strategic, efficient, and effective project management capabilitiesnnnGeneral knowledge of drug substance and drug product release, stability and extended characterization testing for vaccines and/or biologicsnnnStrong technical, verbal, and written communication, interpersonal and teamwork skillsnnnAbility to travel up to 25%nnnnPreferred Qualifications:nnnContinuous improvement or Project Management trainingnnnGlobal supply or launchnnnPromoting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA)nnnAuthoring and/or reviewing technical documents to promote Process Performance Qualification (PPQ)nnnAnalytical or Project guide knowledgennnMethod transfer with an external contract laboratory or global sitesnnnnOur Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network thatu2019s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.u00a0nnWho we are u2026 nWe 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.nnWhat we look for u2026 nImagine 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 usu2014and start making your impact today.nnNOTICE FOR INTERNAL APPLICANTSnIn 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.nnIf 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.nnCurrent Employees apply HEREnnCurrent Contingent Workers apply HEREnnUS and Puerto Rico Residents Only:nnOur company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.nFor more information about personal rights under Equal Employment Opportunity, visit:nEEOC PosternEEOC GINA Supplementu200bnOFCCP EEO SupplementnPay Transparency NondiscriminationnnWe 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 anotheru2019s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.nnSearch Firm Representatives Please Read Carefullyu00a0Merck & 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. u00a0No 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.u00a0nnEmployee Status: nRegularnnRelocation:nNo relocationnnVISA Sponsorship:nNonnTravel Requirements:n25%nnFlexible Work Arrangements:nnShift:n1st - DaynnValid Driving License:nNonnHazardous Material(s):nNonnNumber of Openings: n1nRequisition ID:R166388n,occupationalCategory:Senior Scientist}

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