Senior Specialist Ms&T

OverviewThe Senior Specialist MS&T (Analytical Sciences) provides a range of analytical technical support to the site, focusing on Manufacturing Sciences and Technology (MS&T) Process Sciences, Manufacturing and Quality Control.Acts as Analytical Method and PAT SME while leading the use of the latest innovations in technology and automation to create a workplace of the future.ResponsibilitiesServing as a biologics analytics and characterization subject matter expert, providing technical input to teams, and coaching associate staff.Provide technical leadership for:Experimental design, execution, data analysis and interpretation.Development, transfer and qualification of assays.Lead and support various manufacturing science and technology organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).Technical point of contact for Process Analytical Technologies (PAT).Authoring and reviewing of documents including User Requirements Specifications (URSs), Risk Assessments, Protocols, Reports, Standard Operating Procedures (SOPs), and work instructions.Technical lead for characterization testing, ensuring testing conducted either internally or externally.Serving as a key member during internal audits and external inspections/audits.Supporting multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus.Qualification and ExperienceBachelor's degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry.Excellent oral and written communication skills, with the ability to effectively articulate understanding of process science.Experience with analytical testing in support of upstream cell culture and downstream purification of biological molecules.Experience with technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics is a plus.Analytical Chromatography experience ideally with some Mass Spectrometry experience.Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisations for development and/or manufacturing.Working knowledge of statistical methods for DOE design and data analysis (e.g., JMP or Design Expert software).Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world\'s most challenging healthcare needs.As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.Please contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.Please feel free to speak to us about what flexibility means to you during your application.Required SkillsAdaptability, Assay Development, Biochemical Assays, Cell-Based Assays, Cell Cultures, Chemistry, Data Analysis, Data Interpretations, Detail-Oriented, Documentations, Estimation and Planning, High-Performance Liquid Chromatography (HPLC), Interdisciplinary Collaboration, Interpersonal Relationships, Liquid Chromatography-Mass Spectrometry (LC-MS), Mammalian Cell Culture, Mass Spectrometry (MS), Process Design, Process Improvements, Project Planning, Regulatory Compliance, Root Cause Analysis (RCA), Statistical Process Control (SPC), Technical LeadershipPreferred SkillsCurrent Employees apply HERE.Current Contingent Workers apply HERE.NotesSearch Firm Representatives Please Read Carefully: Merck & Co., Inc., Rahway, 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 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:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not ApplicableShift:Valid Driving License:Hazardous Material(s):Job Posting End Date:10/17/2025A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID:R******#J-*****-Ljbffr