Project Manager, Operations Management, Regulatory Compliance Specialist

Overview

Join Us in Bringing Hope to Life. Our purpose is to bring hope to life by enabling life‑changing therapies for patients around the globe, creating a healthier and happier tomorrow. We value excellence, collaboration, and meaningful work. This role is a Project Manager for biologics programs across the full product lifecycle.

• Lead CMC development, technology transfer, and GMP manufacturing programs from project initiation through close-out.
• Develop and maintain project plans to ensure delivery within scope, timeline, and budget.
• Serve as the primary point of contact for clients, providing clear communication and program leadership.
• Partner with Business Development to strengthen client relationships and support program growth.
• Identify project risks, develop mitigation strategies, and facilitate issue resolution with functional leaders.
• Establish contingency plans and escalate critical issues as needed.
• Drive alignment across Process Development, Analytical, QC, QA, MSAT, Supply Chain, and Manufacturing teams.
• Support late-stage activities including PPQ readiness, regulatory submissions, and commercialization efforts.
• Apply technical understanding of biologics development and manufacturing to support decision-making and technology transfer activities.
• Manage project financials and contractual commitments, including Project Change Orders.
• Provide milestone updates and forecasting information to support financial planning and client invoicing.

• Required: Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, Engineering, or a related field.
• 3–8 years of experience within biopharmaceutical, biotechnology, or CDMO environments.
• 2–5 years of direct project management experience.
• Strong knowledge of GMP regulations and regulated manufacturing environments.
• Experience with project management tools such as PPM systems or Smartsheet.

• 2+ years of CDMO experience.
• Experience supporting late-stage programs, including PPQ, BLA preparation, and commercialization activities.
• Experience leading technology transfers and new product introductions.
• Familiarity with Track Wise.

Location:

Bothell, WA
•

Schedule:

Full-time

Compensation: $94,000 – $129,250

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence in the United States. From our headquarters in Bothell, Washington, we develop and manufacture life‑changing advanced biologics for some of the world’s most innovative pharmaceutical companies. We work with our team members across Europe, the U.S., and Japan to deliver development and manufacturing of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cell therapies.

We are a collaborative, inclusive, and equal‑opportunity organization where team members are valued for their expertise, teamwork, and ingenuity. We invite you to explore our current opportunities and join our journey.