**Job Description** **Job Description:** The Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) is seeking a highly motivated Senior Scientist to join our Regulated PK & ADA Bioanalytical group at our Innovation Park in Spring House, PA. We are looking for candidates with experience in bioanalysis of biotherapeutics to support the immunogenicity requirements of regulated drug development studies. Collaboration, innovation, teamwork, and accountability are highly valued within our team. The primary role of the successful candidate will be to design and develop cell and non-cell based neutralizing antibody assays for our biologics pipeline. The individual will be responsible to contribute with limited supervision to all aspects of assay development, qualification/validation, technology transfer, and/or troubleshooting. Preferably, the successful candidate should have a proven track record for developing assays capable to meet Regulatory expectations for validation and line of sight for life-cycle maintenance. **Job Location:** + SHIP, PA **Main Responsibilities include but are not limited to:** + Method development and validation of neutralizing antibody assays for different therapeutics. + Generation of quality data to support clinical studies + Assisting in establishing and managing bioanalytical lab operations, including automation and analytical instrumentation. + Contribution to the authoring of method development reports, test methods, qualification and validation reports, and study reports + Communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to author technical reports, and to participate on cross-functional teams. + Responding to regulatory authorities pertaining to bioanalytical strategy and execution. + Contribute to the assessment and implementation of new analytical technologies. + Serve as an internal subject matter expert on developed assays, providing technical support, as needed to internal and external laboratories working to implement assays. + Demonstrates urgency and sensitive to meet project timelines. Providing timely delivery of high-quality quantitative data to cross-functional collaborators for neutralizing antibody analysis. **Education Minimum Requirements** + B.A./B.S. in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or bio-related science with a minimum of 7+ years of relevant experience + Master’s degree in biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or bio-related science with 4+ years of experience + Ph.D. in in Biology, Immunology, Molecular Biology, Chemistry, Biochemistry, Pharmaceutical Sciences bio-related science with 0-3 years of relevant industry experience **Required Experience and Skills:** + Demonstrated expertise developing, troubleshooting, and performing bioanalytical assays in plate-based and cell-based neutralizing antibody (NAb) assays for different therapeutics. + Experience in different bioanalytical technology platforms, such as ELISA, our Company, Ensight, Envision, Biacore/SPR etc. + Knowledge of GLP requirements and understanding of current industry trends and regulatory expectations associated with bioanalytical science. + Strong verbal and written communication skills with the ability to deliver ideas to an interdisciplinary team. + Proven experience thinking critically and ability to solve complex technical issues + Ability to follow established procedures, develop new protocols, and strong attention to detail. + Capable of working efficiently and multitasking in a fast-paced environment + Competent individual that maintains full accountability for data generated and can work collaboratively in an organized setting **Preferred Experience and Skills:** + Previous work experience in regulated industry environment and a solid understanding of current GLP standards + Knowledge and expertise in assay qualification/validation and troubleshooting of cell-based assays and/or ligand-binding assays. + Experience with new modalities like bispecific, T-Cell engager, etc. + Use of automation platforms to perform preclinical and clinical assays. Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.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. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) EEOC GINA Supplement​ Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_%20English\_formattedESQA508c.pdf) We 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. Learn more about your rights, including under California, Colorado and other US State Acts (https://www.msdprivacy.com/us/en/CCPA-notice/) **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, 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 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:** Regular **Relocation:** Domestic **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** N/A **Job Posting End Date:** 02/27/2025 ***A 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:** R335883