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Sr. Spclst, Project Management

at Merck

Merck2 LocationsPosted 2026-06-03
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Job description

Job DescriptionSenior Specialist, External Development & Manufacturing (ExDM) – Program Lead (P3)Job DescriptionOur company's Pharmaceutical Sciences and Device Development (PSDD) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench to Good Manufacturing Practice (GMP) manufacturing facilities, our scientists and engineers use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients. The External Development and Manufacturing (ExDM) team within PSDD is focused on executing the company's Research Laboratories drug product and device development sourcing strategy across all phases of small and large molecule research and development operations.The Senior Specialist, External Development & Manufacturing (ExDM) Program Lead (P3) independently leads external manufacturing activities supporting clinical development. This role serves as the primary ExDM representative on cross-functional teams, integrating technical, operational, and financial workstreams to ensure reliable, compliant, clinical supply delivery. This role requires strong ownership, accountability, and collaboration, with a focus on executional excellence, continuous improvement, and strong external partnerships.Key ResponsibilitiesLead execution of external manufacturing programs across Contract Manufacturing Organizations (CMOs), including planning, coordination, risk management, and issue resolution.Track and manage CMO key performance indicators (KPIs) and metrics to drive performance.Represent ExDM on project teams and align external manufacturing strategies with program objectives.Manage GMP-related activities such as batch record and specification review, change control, release support, investigations, and material coordination.Serve as the primary liaison with external partners, driving performance in quality, delivery, and cost.Oversee billing, purchase orders, and financial forecasting for assigned programs, while improving financial workflows and reporting.Collaborate across Technical Operations, Quality, Global Clinical Supplies, Procurement, and other partner groups to resolve complex technical and operational challenges.Identify and implement process improvements across internal workflows and vendor interfaces.Serve as a subject matter expert in selected technical or business areas and contribute to organizational capability building.Mentor and support junior team members through coaching, knowledge sharing, and project guidance.Use digital tools, analytics, and AI-enabled platforms to improve efficiency, decision-making, and communication.Education Minimum Requirement:B.S. with minimum of 5 years relevant industrial experience, orM.S. with 3 years of experience in Chemical Engineering, Pharmaceutical Sciences, or related engineering/scientific discipline. Required Experience and Skills:Relevant experience in clinical manufacturing, supply chain, or external manufacturing management within the pharmaceutical industryWorking knowledge of GMP operations, batch release, investigations, and quality systemsStrong project management, problem-solving, and stakeholder management skillsAbility to work independently and lead effectively in a matrixed environmentPreferred Experience and Skills:Experience working with external partners or CMOsAdvanced degree in a relevant disciplineExperience leading external manufacturing or development programsDemonstrated success driving process improvements and scalable solutionsAbility to influence across cross-functional teams and external partnersExperience mentoring junior colleaguesDigital fluency, including analytics and AI-enabled productivity toolsRequired Skills: Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA Supplement​We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 ActsThe salary range for this role is$106,200.00 - $167,200.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits.  Available
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