Job Description Large Molecule Science and Technology (LMS&T) Technical Product Leadership (TPL) is seeking a highly motivated person for the role of Senior Specialist, Vaccine Technical Product Leadership. This role will provide end-to-end manufacturing science and technology support for MMR, Varivax, ProQuad, and Sterile Diluent (MMRV+SD) across the following sites: West Point, PA, Durham, NC and various packaging and external manufacturing facilities. MMRV+SD TPL is a customer-focused global technical support group with the primary goal to partner with key business units and customers to identify and implement innovative technical solutions and operational improvements that promote both process and supply chain robustness across the lifecycle of the product. The Senior Specialist in the MMRV+SD TPL will partner with groups across the Company, including Technical Operations, Operations, Quality, commercialization, process development, Devices, Regulatory-CMC, Supply Chain, and Value Chain. Key functions: Coordinate technical teams across the network to achieve MMRV+SD strategic goals & project portfolio. Apply vaccine product/manufacturing process subject matter expertise to plan and lead complex multi-site investigations and drive above-site/global projects Provide on-site support for critical site investigations and specialized technical requests. Collaborate and engage with key functional leads within LMS&T, site manufacturing, commercialization, Research Laboratories, device technical ops, and process development/support laboratories to identify and implement opportunities for enhanced process robustness Build and maintain strong and trusting relationships with site counterparts, functional management, and other stakeholders to ensure effective communication of plans and issues Actively identifies vulnerabilities in end-to-end control strategy to highlight risk and drive mitigating solutions. Execution of rigorous proactive process analysis (PPA) plans across the MMRV+SD products Use tools & systems to understand & communicate product health (eg process health index, sister site evaluations) and support technical lifecycle management and risk reduction (eg master comparability plans, knowledge management tools). Education Minimum Requirement: B.S. in Chemical Engineering, Biochemical Engineering, Bioengineering, Pharmaceuticals, Biochemistry, or related field with six (6) years of relevant experience; or M.S. with four (4) years of relevant experience; or Ph.D. with minimum 2 years of post-doctorate experience Required Experience and Skills: Demonstrated problem solving, effective verbal and written communication, and strong interpersonal skills Strong scientific understanding of vaccine and/or biologic products and processes and their effective integration with relevant regulatory/GMP requirements Collaborate effectively, across functional boundaries, to align or influence stakeholders and sponsors to provide technical solutions Demonstrated leadership and ability to drive results; takes initiative Ability to work independently to drive projects to completion; Self-motivated & self-directed Ability to travel up to 25% depending upon critical project and site needs Preferred Experience and Skills: Minimum 3 years direct experience in vaccine or biologics process development, commercialization, or manufacturing Experience authoring technical documentation Experience managing small teams and project teams Current Employees apply HERE Current Contingent Workers apply HERE 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 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 EEOC GINA Supplement Pay Transparency Nondiscrimination 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 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: 25% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 11/22/2024 *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:R321409