Biologics Program Lead – GMP & Tech Transfer

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

Job summary

AGC Biologics in Bothell, WA seeks a Project Manager to drive biologics programs across the full lifecycle, from technology transfer through GMP manufacturing. You will ensure on-time, on-scope delivery within budget while aligning with client expectations and regulatory requirements.

The role requires strong cross-functional collaboration across Process Development, Manufacturing, Quality, MSAT, Analytical, Regulatory and Supply Chain, plus proactive risk management and financial stewardship.

Qualifications

• 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 (preferred).
• Experience supporting late-stage programs, including PPQ, BLA preparation, and commercialization activities.
• Experience leading technology transfers and new product introductions.
• Familiarity with TrackWise.

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.

Skills

Communication

Cross-functional leadership

Problem solving

Financial acumen

Project planning

Education

Bachelor’s degree in Life Sciences, Chemistry, Biotechnology, Engineering, or related field

Tools

Smartsheet

PPM systems

Job description

AGC Biologics in Bothell, WA seeks a Project Manager to drive biologics programs across the full lifecycle, from technology transfer through GMP manufacturing. You will ensure on-time, on-scope delivery within budget while aligning with client expectations and regulatory requirements.

The role requires strong cross-functional collaboration across Process Development, Manufacturing, Quality, MSAT, Analytical, Regulatory and Supply Chain, plus proactive risk management and financial stewardship.