Biologics Program Manager: CMC & GMP Lead

AGC Biologics; Bothell (WA); On-site; USD 94,000 - 129,000; Full time

Job summary

AGC Biologics in Bothell, WA is seeking a Project Manager to lead biologics programs from technology transfer through GMP manufacturing and PPQ readiness. You will ensure delivery on time, within scope, and within budget while aligning with client expectations and regulatory requirements.

You will coordinate across Process Development, Manufacturing, Quality, MSAT, Analytical, Regulatory, and Supply Chain to drive successful program delivery, manage risks, and support commercialization with

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, Engineering, or related field.
• 3–8 years of experience in biopharmaceutical 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.

Responsibilities

• Lead CMC development, tech 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.

Skills

Communication skills

Cross-functional leadership

Problem solving

Financial acumen

Planning & organization

Education

Life sciences degree

Tools

Smartsheet

PPM systems

Job description

AGC Biologics in Bothell, WA is seeking a Project Manager to lead biologics programs from technology transfer through GMP manufacturing and PPQ readiness. You will ensure delivery on time, within scope, and within budget while aligning with client expectations and regulatory requirements.

You will coordinate across Process Development, Manufacturing, Quality, MSAT, Analytical, Regulatory, and Supply Chain to drive successful program delivery, manage risks, and support commercialization with