QC Lab Start-Up Director

Kyowa Kirin, Inc.- U.S.

Sanford (NC)

On-site

USD 157,000 - 206,000

Full time

4 days ago

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Benefits offered by this job

401K with company matching

Annual Bonus Program

Generous PTO

Healthcare Benefits

HSA & FSA

Well-Being Programs

Long-Term Incentive Program

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Kyowa Kirin North America, Inc. is seeking an Associate Director, Quality Control in Sanford, NC, to design and execute the operational readiness program for start-up of QC laboratories at the new monoclonal antibody drug substance facility.

The role leads milestones to ensure production targets are met in a greenfield environment, transitioning to lab operations through GMP-ready, tech transfer, and licensure activities for Phase III and commercial products.

Qualifications

Bachelor’s degree in life sciences is required.
Minimum 10 years of management experience leading GMP Bio-Pharmaceutical QC labs.
Experience managing Quality Assurance teams within biopharmaceutical manufacturing.
Experience starting up and operating a biopharma manufacturing facility is a plus.

Responsibilities

Lead QC Lab operations to achieve required validation and qualification activities.
Ensure laboratory systems comply with 21 CFR Part 11 and data integrity (ALCOA++).
Hire, onboard, train, and mentor QC staff per staffing plans.
Coordinate regulatory readiness and respond to inspections.
Collaborate cross-functionally to drive technology transfer and site startup milestones.