Senior Biopharma Manufacturing Operator – On-Site Startup

Kyowa Kirin, Inc.- U.S.; Sanford (NC); On-site; USD 69,000 - 94,000; Full time

Benefits offered by this job

401(k) with Company Match

Annual Bonus Program

Generous PTO and Holiday Schedule

Sick Days

Volunteer Days

Healthcare Benefits

HSA & FSA Programs

Well-Being and Work/Life Programs

Life & Disability Insurance

Concierge Services

Long-Term Incentive Program

Pet Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Kyowa Kirin North America, a leading biopharmaceutical company, seeks a Senior Manufacturing Operator to start up and run core manufacturing operations on a greenfield site for rare disease therapies. You will model safety and compliance, perform complex upstream and downstream work in a GMP setting, troubleshoot and drive improvements.

You will collaborate with Engineering, Automation, CQV, and Quality teams to build a high-performing manufacturing platform, including equipment commissioning,

Qualifications

• Bachelor’s degree in a technical field required.
• 4+ years biopharmaceutical manufacturing experience.
• Experience with upstream and downstream processes.
• Experience with cGMP and Data Integrity (ALCOA+) practices.

Responsibilities

• Execute manufacturing operations for mAb using PCS & MES.
• Adhere to cGMP, safety, and Data Integrity standards.
• Maintain accurate batch records, logs and docs.
• Lead process improvements to optimize operations and reduce waste.
• Train new colleagues and junior staff in processes and safety.
• Assist during equipment commissioning, validation, and qualifications.

Skills

Biopharmaceutical manufacturing

GMP/compliance

Equipment operation

Process troubleshooting

Documentation

Education

Bachelor's degree in Chemical Engineering, Chemistry, Biology, or related

Tools

DeltaV

Unicorn

Ignition

Job description

Kyowa Kirin North America, a leading biopharmaceutical company, seeks a Senior Manufacturing Operator to start up and run core manufacturing operations on a greenfield site for rare disease therapies. You will model safety and compliance, perform complex upstream and downstream work in a GMP setting, troubleshoot and drive improvements.

You will collaborate with Engineering, Automation, CQV, and Quality teams to build a high-performing manufacturing platform, including equipment commissioning,