Lower Gwynedd, PA, 19002, USA
1 day ago
Associate Principal Scientist, Bioanalytical Regulated Immunogenicity and Molecular
**Job Description** 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 seeking a highly motivated Associate Principal Scientist to join the Department of Pharmacokinetics, Dynamics, Metabolism, and Bioanalysis (PDMB) in the area of Bioanalytical Regulated Immunogenicity and Molecular. Our team is modernizing Bioanalytics with regulated end-to-end automation, data tracking, analysis, and visualization, and automated liquid handling. The primary role of the successful candidate will be to design and develop immunology-based preclinical and clinical assays for our vaccines pipeline. The individual will be responsible to lead vaccine bioanalytical assay development, qualification/validation, technology transfer, and/or troubleshooting to meet regulatory expectations for validation and line of sight for life-cycle maintenance. Importantly, the successful candidate will have a proven track record for developing bioanalytical assays with a close hands-on connection to laboratory activities. The candidate should be current on state-of-the art technologies and champion the evaluation of new technologies and optimization of processes. Providing leadership and mentorship to junior staff, building relationships with stakeholders, and providing expert technical representation on multidisciplinary teams will be expected. **Responsibilities:** + Provide scientific input and strategy to design of immunoassays such as Luminex, Mesoscale, and/or cell-based functional immunogenicity assays preclinical and clinical regulated studies. + Method development, qualification/validation, troubleshooting and/or assay format selection based on risk assessment and fit-for-purpose considerations. Support of pre-clinical/clinical sample analysis as needed. + Understand, leverage, and implement different automation strategies including Biomek, Hamilton, or Tecan liquid handlers to reduce hands-on time and increase throughput. + Strong scientific background and interest in associated laboratory experimentation. + Assess and implement new technologies with consideration for longevity and problem solving. + Serve as an internal subject matter expert on developed assays, providing technical support to internal and external laboratories working to implement assays. + Ensure assays are developed and executed in compliance with applicable regulatory guidance. Develop assay protocols, qualification plans, and reports. Address QA findings and observations. + Contribute to regulatory filings and responses pertaining to assay details as needed. + Communicate results effectively in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams. + Adherence to basic safety procedures in a BSL2 laboratory and compliance to regulations. **Qualifications:** **Minimum education required:** + PhD in Biological Sciences such as Virology, Immunology, Cell biology or related area with 4+ years, or a Masters degree with 8+ years, or a Bachelor degree with 12+ years of experience in the field of relevant experience in the development and execution of assays in a regulated bioanalytical environment. **Required experience and skills:** + Subject matter expert in the field of regulated analytical and/or bioanalytical development of cell-based or ligand-binding-based assays. + Experience with experience with immunology assays such as ELISA, AlphaLISA, multiplexed ligand binding assays (LBA) on Mesoscale and/or Luminex platforms. + Deep knowledge and expertise in development, qualification/validation, and troubleshooting of regulated cell-based or ligand binding-based assays. Track record in designing assays for pre-clinical and/or clinical applications. + Familiarity with Regulated Bioanalysis and Good Laboratory Practice (GLP) is strongly desired. + Demonstrated supervision and mentorship of small teams is highly preferred. + Hands-on familiarity with liquid handlers and other automation platforms for sample preparation and assay process is strongly desired. Candidates must be able to leverage and implement automation. + Ability to independently analyze and interpret experimental data and to present and discuss results within a multi-disciplinary team environment. + A team player with excellent oral and written communication skills as evidenced by scientific publications and presentations at scientific meetings. **NOTICE FOR INTERNAL APPLICANTS** In 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. \#EBRG #vetjobs #DPTM **Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.** 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, generally Tuesday, Wednesday and either Monday or 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”. **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:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** BSL-2 **Job Posting End Date:** 10/7/2024 ***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.** **Job Posting End Date:** 10/07/2024 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:** R308964
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