Project Manager

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.

Job Summary

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

The Project Manager serves as the primary liaison between clients and internal cross-functional teams, driving alignment across Process Development, Manufacturing, Quality, Regulatory, MSAT, Analytical, and Supply Chain. This position is accountable for planning, execution, risk management, financial oversight, and effective communication throughout the project lifecycle.

Your Key Responsibilities

• Lead CMC development, technology transfer, and GMP manufacturing programs from project award through close-out.

• Develop and maintain detailed project plans to ensure right-first-time delivery within scope, timeline, and budget.

• Serve as the primary point of contact for clients, ensuring clear communication and alignment of expectations.

• Partner with Business Development to support and strengthen client relationships.

• Proactively identify risks, develop mitigation strategies, and resolve technical or operational challenges in collaboration with functional leads.

• Establish contingency plans, monitor risk triggers, and escalate issues as needed.

• Drive cross-functional alignment across PD, Analytical, QC, QA, MSAT, Supply Chain, and Manufacturing.

• Support late-stage program activities including PPQ readiness, regulatory submissions (e.g., BLA), and commercialization efforts.

• Apply knowledge of biologics development, including cell line development, upstream and downstream processing, and analytical requirements, to support technical decision-making and tech transfer activities.

• Manage financial and contractual aspects of programs, including authoring Project Change Orders.

• Provide accurate milestone updates to Finance for forecasting, work assessment, and timely client invoicing.

Key Skills

• Strong written and verbal communication skills with the ability to manage senior stakeholders.

• Ability to lead cross-functional teams without direct authority.

• Effective problem-solving and conflict resolution skills.

• Solid financial acumen with understanding of contracts and invoicing processes.

Qualifications

Required

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

• 3–8 years of experience in biopharmaceutical, biotech, or CDMO environments.

• 2–5 years of direct project management experience.

• Strong knowledge of GMP regulations and operating within a regulated environment.

• Proficiency with project management tools (e.g., PPM systems, Smartsheet).

Preferred

• 2+ years of CDMO experience.

• Experience managing late-stage programs (PPQ, BLA preparation, commercialization readiness) and/or commercial programs.

• Experience leading technology transfer and new product introductions.

• Familiarity with TrackWise.

Location: Bothell, WA
Schedule: Full-time
Compensation: $94,000 - $129,250

Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe. 

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  Want to keep posted about our growth and learn more about our company? Follow us on LinkedIn and give us a quick Like on Facebook!

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.