Senior Manufacturing Operator

Kyowa Kirin North America•Sanford, NJ

3d•Onsite

About The Position

As a Senior Manufacturing Operator supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will be tasked to start up and execute core manufacturing operations. You will be a role model for Safety and Compliance. You will execute complex upstream and downstream processes in a GMP environment, contribute to troubleshooting and continuous improvement efforts, ensure compliance with regulatory standards, and train and mentor other manufacturing associates. Your role will be highly collaborative, working across Engineering, Automation, and Quality teams to help build a high-performing, patient-centered manufacturing platform from the ground up. This includes hands-on involvement 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.

Requirements

Bachelor's degree plus a minimum of 4 years of relevant biopharmaceutical manufacturing experience; OR Associate's degree plus a minimum of 6 years of relevant biopharmaceutical manufacturing experience; OR High School Diploma/GED plus a minimum of 8 years of relevant biopharmaceutical manufacturing experience.
Experience with relevant Upstream operations, including: Vial Thaw/Inoculation, Wave Bioreactors, Single-Use Bioreactors (50L, 500L, 3000L), Harvest Operations.
Experience with relevant Downstream operations, including: Chromatography, Viral Inactivation, Viral Filtration, TFF Systems, Bulk Filling.
Direct Upstream and Downstream GMP manufacturing experience required.
Knowledge of Agile and Lean Manufacturing principles and Standard Work.
Proficiency with Microsoft Office applications.
Strong problem-solving and critical-thinking skills.
Ability to maintain clean manufacturing environments in accordance with GMP and safety standards.
Ability to read and interpret technical documents.
Ability to troubleshoot and operate production equipment.
Ability to perform basic math and statistics.
Strong written and verbal English communication skills.
Results-oriented with the ability to navigate ambiguity and drive measurable outcomes.
Strong accountability and follow-through on commitments.
Adaptability and resilience in a rapidly changing environment.
Excellent organizational skills and attention to detail.
Strong communication and interpersonal skills.
Ability to foster collaboration across diverse teams and perspectives.
Commitment to continuous learning and knowledge sharing.
Growth mindset with a focus on innovation and process improvement.
Ability to build inclusive and supportive working relationships.
Enterprise mindset that prioritizes collective success and integrated solutions.

Nice To Haves

Bachelor's degree in a technical field (Chemical Engineering, Chemistry, Biology, or related discipline) preferred.
Experience supporting startup and operation of a biopharmaceutical manufacturing process preferred.
Experience authoring or editing SOPs preferred.
Experience with electronic records and PCS software such as DeltaV, Unicorn, Ignition, or similar systems preferred.

Responsibilities

Execute manufacturing operations utilizing standard work on the manufacturing floor for mAb manufacturing, including weigh and dispense, bioreactors, filtration equipment, inoculum preparation, chromatography skids, and/or UF/DF skids via PCS and MES.
Ensure all processes are performed according to Safety and Compliance policies and procedures, current Good Manufacturing Practices (cGMP), and all other applicable requirements, including adherence to Data Integrity practices (ALCOA+).
Adhere to operational procedures and master records and follow both written and verbal instructions from supervisors.
Maintain accurate records, including batch records, log sheets, and other required documentation.
Escalate any and all non-compliance events (perceived or actual) in a timely manner.
Ensure compliant and efficient operations throughout commissioning and manufacturing operations by collaborating with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams.
Develop operational SOPs, participate in FATs, and facilitate equipment validation and qualification in conjunction with Engineering teams.
Identify and implement process improvements to optimize operations.
Propose and lead initiatives to streamline workflows and eliminate waste.
Stay current on industry trends and technologies to drive innovation in production planning.
Utilize 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 and support CAPA tracking and documentation.
Maintain cleanliness and organization of manufacturing areas through routine cleaning and preventative maintenance.
Manage shop floor activities through 5S, Standard Work, and Kanban methodologies.
Coordinate with Warehouse and Maintenance teams to ensure uninterrupted availability of materials, supplies, and equipment.
Train new colleagues and junior staff in manufacturing processes, equipment operation, safety procedures, and company standards.
Assist during technical transfer activities for new products and manufacturing processes.