Director Manufacturing Operations (m/f/d)

Company: Merck Gruppe - MSD Sharp & Dohme
Location: Rahway
Posted on: April 6, 2025

Job Description:

Job DescriptionDirector Manufacturing Operations (m/f/d)A fantastic opportunity has arisen for a Manufacturing Operations Director. This position will drive operational excellence to deliver all components of a stable manufacturing team and process for early/late-stage Clinical Supply at our Biologics facility at our site in Schachen.The Manufacturing Operations Director (m/f/d) leads an Operating Unit responsible for manufacturing biologics drug substance in an efficient and timely manner through application of state-of-the-art technologies for batch and continuous manufacturing with a Quality First, Safety Always Mindset. The Manufacturing Operations Director (m/f/d) leads teams responsible for Technology Transfer, Process Operations, and Support operations. The teams operate within a framework of regulatory compliance and established high standards of Quality, Good Manufacturing Practices (GMP) and Environmental Health & Safety protection. The Manufacturing Operations Director (m/f/d) shapes the direction of the pipeline by integrating an innovative/strategic focus and a high customer service level, fostering a strong performance orientation and effectively collaborating across the organization. He or she ensures a culture of self-direction, empowerment and accountability, while providing the support necessary to team members working in a widely cross-functional organization.The primary activities include but are not limited to the following:Leadership:

• Sets performance targets that align with business priorities and drives continuous improvement initiatives.
• Develops the organization and culture (including values and behaviors such as empowerment, diversity, equity, and inclusion, accountability, trust, open communication).
• Serve on the Site Coordination Team to develop and deliver toward site and organizational priorities and strategy.
• Manage and develop operations team personnel toward strong, empowered leaders. Build, inspire, reward and develop diverse talent with the capabilities necessary to succeed in manufacture.
• Drive execution and operational excellence by applying Lean principles to foster continuous improvement mindset to deliver a productive and agile operating model.
• Resolve resource and prioritization constraints and support resource needs and changes.Management:
  • Drive a strong compliance mindset within the organization, including proactive safety and quality culture, and adherence to all regulatory expectations (GMP and EHS).
  • Establish and deliver on KPI's in a timely manner, including schedule adherence, training, hiring, uptime, change controls, investigations, CAPAs, capital/expense targets, sustainability targets, yield/volume/cadence/operational availability, Right First Time, and timely documentation closure.
  • Oversees planning and coordination of Manufacturing Operations activities including manufacturing and process technology transfers.
  • Designs and operationalizes technology transfer processes that deliver right first-time manufacturing of biologics to support the pipeline.
  • Responsible for prioritization of proposed risk mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process.
  • Provide clear direction and definition of any new project scope, goals and deliverables, to the site and functional teams on an ongoing basis.
  • Resolve issues and identify risks in a timely fashion to the relevant on-site and above-site Stakeholders.
  • Manage financial forecasts and workload to achieve departmental headcount and pipeline deliverables.If you are passionate about leading innovative manufacturing operations and inventing solutions to meet unmet healthcare needs, please apply today.Required Education, Experience and Skills:
    • Bachelor's degree (B.S.) or equivalent in biology, chemical engineering, or a related discipline with at least 12 years or master's degree (M.S.) with at least 10 years previous experience in a relevant position in GMP manufacturing in the pharmaceutical or biotech industry.
    • Experience in GMP drug substance manufacturing using mammalian cell culture, including upstream and downstream processing.
    • Strong leadership and interpersonal skills, including leading and coaching direct team to drive a high-performance organizational culture that accommodates rapid growth & highly dynamic operating execution.
    • The desire to continuously learn, improve and grow, and cultivate continued development within the team.
    • Experience in leading cross-functional teams (Manager of Managers).
    • Excellent oral/written communication skills in English (C1), and German (B2).Preferred Experience and Skills:
      • Qualification and training in economics and LEAN management.
      • Experience with evolution of regulatory requirements.
      • Experience with Cross-Functional Investigations and Root Cause Analysis Techniques.We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact on our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Employee Status: RegularRelocation: InternationalVISA Sponsorship: YesTravel Requirements: 10%Flexible Work Arrangements: Not ApplicableShift: Not IndicatedValid Driving License: NoHazardous Material(s): N/AJob Posting End Date: 05/1/2025*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: R343154
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Keywords: Merck Gruppe - MSD Sharp & Dohme, Wilmington , Director Manufacturing Operations (m/f/d), Executive , Rahway, Delaware