Senior Manufacturing Associate

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

As a Senior Manufacturing Associate supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will be responsible for starting up and executing core manufacturing operations. You will serve as a role model for safety and compliance, executing complex upstream and downstream processes in a GMP environment. Your responsibilities will include contributing to troubleshooting and continuous improvement efforts, ensuring compliance with regulatory standards, and training and mentoring other manufacturing associates.

This role is highly collaborative, involving close coordination with engineering, automation, and quality teams to help build a high-performing, patient-centered manufacturing platform from the ground up. You will be hands-on in equipment commissioning, process validation, and the implementation of automated systems.

As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.

This role reports into the Manager, Manufacturing

Technical Skills, Knowledge, and Experience
•    Execute manufacturing operations using standard work procedures for mAb production, including weigh and dispense, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and UF/DF skids via PCS and MES.
•    Ensure all processes are performed in accordance with safety and compliance policies, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements, including adherence to Data Integrity principles (ALCOA+).
•    Follow operational procedures and master records, ensuring a clear understanding of all requirements. Adhere to both written and verbal instructions provided by supervisors, and seek clarification when needed to ensure compliance and accuracy.
•    Maintain accurate documentation, including batch records, log sheets, and other required records.
•    Escalate all non-compliance events (perceived or actual) in a timely manner.
•    Collaborate with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams to ensure compliant and efficient operations during commissioning and manufacturing.
•    Develop operational SOPs, participate in FATs, and support equipment validation and qualification in partnership with engineering teams.
•    Identify and implement process improvements to optimize manufacturing operations.
•    Propose and lead initiatives to streamline workflows and eliminate waste.
•    Stay current with industry trends and technologies to drive innovation in production planning.
•    Demonstrate proficiency in enterprise systems supporting manufacturing operations, including but not limited to ERP, LIMS, MES, PCS, QMS, and BMS.
•    Lead on-the-floor troubleshooting and resolution of equipment, automation, and process issues; actively support CAPA tracking and documentation.
•    Maintain cleanliness and organization of the manufacturing area through routine cleaning and preventive maintenance, ensuring compliance with GMP and safety standards.
•    Manage the shop floor proactively using 5S, standard work, and Kanban methodologies.
•    Coordinate with warehouse and maintenance teams to ensure availability of materials, supplies, and equipment for uninterrupted production.
•    Partner with Manufacturing Managers to train new colleagues and junior staff on manufacturing processes, equipment operation, safety procedures, and company standards to ensure team competency and adherence to best practices.
•    Actively support the technical trans