Project Manager, Operations Management, Regulatory Compliance Specialist

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.

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.

Your

Key Responsibilities

• 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.

Your Skills

• 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.

Your Qualifications & Experience

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, based on experience

We offer a comprehensive Total Rewards package that may include

• annual bonus opportunities
• paid time off
• medical
• dental and vision coverage
• parental leave
• education assistance
• employee referral and recognition programs
• additional wellbeing benefits

Eligibility and benefits may vary based on role, location, and employment status.

Who We Are

AGC Biologics is a global Contract Development and Manufacturing Organization with a strong presence…