Business Operations Associate

Position Summary

• The Business Operations Associate plays a vital role in supporting the seamless operation of the cell therapy manufacturing facility.
• This onsite position involves managing a broad spectrum of equipment and systems essential to GMP compliance.
• The Associate collaborates with various cross-functional teams to ensure manufacturing continuity, maintain equipment data, support capacity expansion efforts, and uphold audit readiness.
• Additionally, the role encompasses vendor coordination, inventory management, quality support activities, and documentation updates, contributing to a well-organized and compliant manufacturing environment.

• Administer and coordinate system-related tasks for processing equipment and systems in a multi-product manufacturing setting.
• Serve as the primary contact for facility-related activities, working with Technical Services and Facilities & Engineering to prioritize work, plan downtimes, and manage equipment tagging and activation.
• Collaborate with Technical Services, Manufacturing, and Facilities & Engineering teams to execute work efficiently and implement solutions that reduce corrective maintenance and repeat repairs.
• Track and ensure timely addressing of small equipment needs for repairs.
• Coordinate with vendors for service requests and oversee vendor activities on-site.
• Manage service requests, track work order completion, and facilitate cross-functional activities to maintain smooth operations.
• Participate in internal system and manufacturing audits, support CAPA closures, and maintain ongoing inspection readiness by ensuring GMP compliance.
• Assist in spare parts inventory programs, monitor reagent supplies, and coordinate material transfers for routine operations.
• Contribute to Operational Excellence and continuous improvement initiatives by tracking progress and supporting implementation of approved enhancements.
• Support investigations related to equipment-related quality events and corrective action requests, ensuring timely follow-up and resolution.
• Support inventory accuracy, material availability, and continuous facility organization through physical media control and inventory management activities.

• An associate degree or 1-3 years of relevant experience in a cGMP-regulated biotechnology or pharmaceutical manufacturing environment, or a related scientific or engineering field.
• Proven proficiency with manufacturing and automation systems such as Infinity, Syncade, DeltaV, SAP, and Maximo is preferred.
• Ability to work independently as a self-starter and manage multiple priorities in a dynamic, team-oriented environment.
• High proficiency in MS Office applications, especially Word, Excel, and PowerPoint.
• Strong organizational and time management skills to prioritize effectively and contribute to project objectives.
• Flexibility to adapt quickly to changing schedules, including supporting weekend and holiday work as needed.
• Knowledge of Lean processes;
  Yellow Belt or Green Belt certification is a plus.

• Experience with inventory management, vendor coordination, and CAPA processes.
• Familiarity with GMP compliance and quality systems.
• Certification in Lean methodologies, such as Yellow Belt or Green Belt.

• This position offers a meaningful opportunity to contribute to innovative cell therapy manufacturing within a state-of-the-art facility.
• It provides exposure to advanced manufacturing systems and processes, fostering professional growth in a regulated and collaborative environment.
• The role supports operational excellence initiatives and offers the chance to develop cross-functional relationships with diverse teams.
• Additionally, the position encourages a proactive approach to problem-solving and continuous improvement, allowing candidates to make a tangible impact on manufacturing success and compliance.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.