Biopharmaceutical Associate I

Samsung Biologics•Rockville, MD

2d•Onsite

About The Position

Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development and manufacturing services. With proven regulatory approvals, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide.

Requirements

Demonstrating ambition for patients, accountability for impact, and integrity.
Utilize robust documentation and data integrity practices.
Execute and record daily manufacturing tasks in accordance with standard operating procedures, batch instructions, and logbooks.
Monitor equipment and critical process parameters.
Escalate any issues or abnormalities.
Lead troubleshooting efforts where appropriate.
Initiate and contribute to the documentation of investigations arising from safety or compliance concerns.
Provide proactive input on safety and compliance prior to execution for cross-functional initiatives.
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.
Identify and address issues in standard work processes or documentation.
Participate in area musters or shift changeovers.

Nice To Haves

Occasional out-of-suite or off-site assignments (e.g., FAT support) may be required.

Responsibilities

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.