Biopharmaceutical Associate I

Location
Rockville
Workplace
On-site

About this role

 Exemplify Samsung’s Culture—demonstrating ambition for patients, accountability for impact, and integrity—in every interaction, task, and responsibility associated with the role. Consistently embody these values to promote high-performing behaviors in the workplace.

 Utilize robust documentation and data integrity practices to safely and compliantly execute and record daily manufacturing tasks in accordance with standard operating procedures, batch instructions, and logbooks.

 Monitor equipment and critical process parameters, promptly escalating any issues or abnormalities and, where appropriate, leading troubleshooting efforts.

 Initiate and contribute to the documentation of investigations arising from safety or compliance concerns, fostering and modelling full transparency throughout the process.

 Support cross-functional initiatives—including engineering, validation, and technology transfer activities—by providing proactive input on safety and compliance prior to execution. While these duties are primarily based within the production suite, occasional out-of-suite or off-site assignments (e.g., FAT support) may be required.

 Maintain a high level of competence with both current and emerging digital platforms (such as SAP, EBR).

 Provide training and mentorship to less experienced team members.

 Proactively ensure that all processing equipment and necessary materials are available and sufficient to facilitate team success.

 Identify and address issues in standard work processes or documentation to minimize accidents, defects, and waste.

 Participate in area musters or shift changeovers to help maintain adherence to the production schedule.

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