Project Manager

AGC Biologics•Bothell, WA

13d•Onsite

About The Position

AGC Biologics is seeking a Project Manager to lead biologics programs across the product lifecycle, from technology transfer and process development through GMP manufacturing. The role is accountable for delivering projects on time, within scope and budget, while meeting client expectations and regulatory requirements. The Project Manager joins the Program Management team, coordinating activities across Process Development, Manufacturing, Quality, MSAT, Analytical, Regulatory, and Supply Chain. The role serves as the primary client contact, supports client relationships and program growth, manages project risks and financials, and contributes technical understanding of biologics development and manufacturing to program decisions. Responsibilities also include supporting late-stage activities such as PPQ readiness, regulatory submissions, and commercialization.

Requirements

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.
Strong written and verbal communication skills, including 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.

Nice To Haves

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 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 and provide 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.