Project Manager, Regulatory Compliance Specialist, Operations Management

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. To advance this purpose, we rely on team members who value excellence, collaboration, and meaningful work. If this resonates with you, we invite you to explore the role further and apply.

We are looking for a Project Manager to lead biologics programs across the full product lifecycle, from technology transfer and process development through GMP manufacturing. This role is responsible for delivering projects on time, within scope, and within budget while ensuring alignment with client expectations and regulatory requirements.

You will join a Program Management team responsible for leading client programs and coordinating activities across Process Development, Manufacturing, Quality, MSAT, Analytical, Regulatory, and Supply Chain functions. The team plays a critical role in ensuring successful program delivery while maintaining strong client relationships and supporting business growth.

• 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 elevate 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.

• Strong written and verbal communication skills with the ability to engage senior stakeholders and clients.
• Ability to lead and influence cross‑functional teams without direct authority.
• Strong problem‑solving, decision‑making, and conflict resolution skills.
• Financial acumen, including experience managing budgets, contracts, and invoicing processes.
• Strong planning, organization, and project execution capabilities.

• 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.

Bothell, WA

Full‑time

$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. Together with our team members across Europe, the U.S., and Japan, we deliver development and manufacturing of mammalian and microbial‑based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cell therapies.

Across our global network, we are united by one mission:
To work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

We are a collaborative, inclusive, and equal‑opportunity organization where team members are valued for their expertise, teamwork, and ingenuity.