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 to 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.

This position reports to the Associate Director Clinical Supplies Quality (Disposition Lead) and is critical to maintaining the global clinical supply chain via disposition activities for sourced drug product. These are received via various channels (internal and external) to enable packaging activities of clinical finish goods to support our Company for worldwide clinical trials. Areas of focus of this position revolve around the detailed workings of clinical packaging and distribution activities and associated regulatory requirements for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc.

Responsibilities:

• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies and procedures of our Company and compliance with all governing regulations.

• Serve as the point of contact for Sourced Drug Product releases and Shelf-Life Extensions, both ongoing projects and new initiatives.

• Provide support and coordination for quality control laboratory activities related to Sourced Drug Product testing.

• Coordinate and support the preparation of procedures, processes and quality improvements.

• Assists in the coordination of significant quality events including fact-finding, investigation, coordination of clinical quarantine and recovery actions.

• Collaboration across functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.

• Providing on-the-floor support of operational and technical issues; providing immediate responses on the shop floor to deviations and potential deviations.

• Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times.

• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans, when possible.

• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System tools, both in problem solving and day-to-day operational activities.

Your Profile:

Education:

• Bachelor's degree with a technical emphasis in an appropriate scientific or engineering or other closely related field required.

Required Experience and Skills:

• Minimum of 3 years’ experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations.

• Familiarity with batch disposition (release) activities is a strongly preferred skill necessary for success in this position; prior batch disposition experience is a plus.

• Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs) is a plus and a strongly preferred skill.

• Basic understanding in using Microsoft applications (such as Excel, Outlook, PowerPoint, Teams, OneNote and/or Access).

• Background in quality control, quality assurance, auditing or regulatory affairs.

• Effectiveness and creativity in approaching and solving technical problems.

• In-depth working knowledge of current Good Manufacturing Practices (cGMPs) and of regulatory requirements as they apply to the pharmaceutical field or a related area.

• Proficiency in using of the use and maintenance for Microsoft applications (such as Excel, Outlook, Teams and/or Access).

• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.

• Demonstrated teamwork skills and ability to work independently.

• Attention to detail, flexibility and an awareness of production and quality control problems. Ability to independently manage multiple priorities and projects.

Preferred Skills:

• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives.

• Demonstrated analytical and problem-solving skills along with knowledge of Lean Six Sigma and Project Management.

• Computer skills; knowledge and competency in ERP/MES, Trackwise, SAP, PowerPoint, Excel and Word.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

THE COMPANY

Our company has had a presence in Switzerland since 1963. With a regional office and manufacturing/packaging facility, Lucerne is considered the center of operations. Approximately 1,000 people work collaboratively at the four Lucerne locations (Tribschenstrasse, Citybay, Schachen and Kriens). A fifth location has been recently established in Zurich, aimed at accelerating the development and commercialization of many of our company’s medicines and vaccines, which supports our mission to save and improve lives around the world. The new location has a target date of 2021 for operational readiness.

We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.

Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents, produce new products and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

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.