Senior Manufacturing Operator

The role

You will start up and execute core manufacturing operations for a greenfield biopharmaceutical site. You will perform complex upstream and downstream processes in a GMP environment and collaborate with engineering and quality teams.

What you will do

• Execute manufacturing operations for mAb manufacturing including weigh and dispense, bioreactors, and chromatography skids.
• Ensure processes follow Safety and Compliance policies, cGMP, and Data Integrity practices.
• Maintain accurate batch records, log sheets, and required documentation.
• Collaborate with Process Engineering, Automation, CQV, Quality, OPEX, and Warehouse teams.
• Develop operational SOPs and facilitate equipment validation and qualification.
• Identify and implement process improvements to optimize operations.
• Lead on-the-floor troubleshooting for equipment, automation, and process issues.
• Manage shop floor activities through 5S, Standard Work, and Kanban methodologies.
• Train new colleagues and junior staff in manufacturing processes and safety.
• Assist during technical transfer activities for new products.

Required qualifications

• 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.
• Direct Upstream and Downstream GMP manufacturing experience required.
• Knowledge of Agile and Lean Manufacturing principles and Standard Work.
• Proficiency with Microsoft Office applications.
• 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.
• Ability to lift up to 35 pounds and move heavy objects.

Nice to have

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

Benefits

• 401(k) with Company Match
• Annual Bonus Program (Sales Bonus for Sales Positions)
• Generous PTO and Holiday Schedule, including Summer and Winter Shut-Downs
• Sick Days
• Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drug, and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Life & Disability Insurance
• Concierge Services
• Long-Term Incentive Program (subject to job level and performance)
• Pet Insurance

About the company

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines. In North America, the company is headquartered in Princeton, NJ.