The Role
About Outpace Bio
Outpace Bio is pioneering the future of cell therapy for solid tumors by harnessing unrivaled AI-powered protein design. Our mission is to program immune cells for enhanced function inside patients, overcoming key barriers such as poor tumor access, weak survival, antigen escape, and dose-related toxicity. By creating and integrating modular, plug-and-play technology assets, we are developing cell therapies with unprecedented efficacy, transforming how engineered T cells interact with cancer and the immune system to deliver life-changing outcomes. Our multidisciplinary team of scientists, engineers, coders, and cell therapy developers works at the cutting edge of computational protein design, synthetic biology, and immunology. Together, we are reimagining how cells function to unlock novel therapeutic possibilities.Located in Seattle’s vibrant biotech hub overlooking scenic South Lake Union, Outpace Bio is led by pioneers in computational protein design and engineered cell therapies. Our culture is built on a foundation of respect and inclusion, which are fundamental to how we collaborate to revolutionize cell therapy through groundbreaking innovation rooted in rigorous science.
Our Commitment to Diversity
At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences. We are committed to cultivating an open, diverse, and inclusive culture for all employees. Recognizing that the best candidates do not always match all criteria of the job description, we encourage you to apply if you think you would be a good fit for the role and are inspired by our mission to cure disease by pushing the boundaries of biology.
Our Momentum
In August 2024, Outpace Bio secured an oversubscribed $144 million Series B financing, led by RA Capital Management and supported by a premier syndicate of life science investors. This funding accelerates our pipeline of programmed T cell therapies, including our lead candidate OPB-101, a mesothelin-specific chimeric antigen receptor (CAR) T cell enhanced by Outpace’s proprietary OUTSMART™, OUTLAST™, OUTSPACER™, and OUTSAFE™ technologies. OPB-101 is advancing toward IND clearance and first dosing in 2025 for patients with advanced platinum-resistant ovarian cancers. The Series B investment also supports the expansion of our pipeline, enabling us to develop additional transformative therapies leveraging our innovative plug-and-play technology platform.
We are seeking a highly motivated and experienced Senior Project Manager, Chemistry, Manufacturing, and Controls (CMC) to join our team and play a critical role in driving the planning, execution, and oversight of CMC activities across our pipeline.
As a member of the Project & Portfolio Management function, this role will partner closely with the Head of Technical Operations & Quality and Asset Team Leads, and collaborate with cross-functional teams, including Process Development, Analytical Development, Manufacturing, Supply Chain, Quality, Regulatory, and external partners to ensure alignment, efficient execution, and delivery of CMC milestones.
You will foster a high-performing team environment while driving the development and execution of integrated CMC project plans for both preclinical and clinical stage cell therapy programs. As the central source of CMC project status, you will ensure alignment, facilitate timely decision-making, and escalate challenges as needed. In addition to managing individual projects, you will contribute to building project management tools and methodologies to support initiatives across our portfolio. This role may also involve serving as an alliance manager for external partners and vendors. We’re looking for a detail-oriented problem solver who thrives in dynamic environments and is passionate about Outpace’s mission to revolutionize cell therapy. If you’re a CMC project or program management professional eager to work on cutting-edge science with a collaborative team and grow your career, this could be the role for you.
Responsibilities (Position responsibilities may include, but are not limited to):
- Develop and maintain integrated CMC project plans, timelines, and risk management strategies aligned with corporate objectives and program goals.
- Facilitate CMC sub-team meetings and cross-functional meetings, ensuring clear communication of goals, progress, risks, and mitigation strategies.
- Track deliverables and proactively identify & address potential bottlenecks or challenges.
- Support the preparation of CMC-related regulatory submissions, including INDs, BLAs, and briefing documents, by coordinating timelines and deliverables.
- Partner with external CDMOs, CROs, and manage alliances with key suppliers to ensure seamless execution of outsourced activities and maintain alignment with project timelines. Implement and improve project management tools and best practices to enhance team efficiency and performance.
- Develop project dashboards and reports to communicate project status to leadership and key stakeholders.
- Ensure alignment between CMC and broader program teams to support overall development strategy and corporate milestones.
- Support budget planning and resource allocation in collaboration with finance and functional leaders.
Qualifications (Required):
- Bachelor’s degree in a life science, engineering, technology, business, or related field; an advanced degree (MS, PhD, or MBA) is preferred.
- 8+ years of experience in the biotechnology or pharmaceutical industry, with at least 5 years of direct project and portfolio management in a science-based organization, with a strong CMC focus.
- Proven experience managing cross-functional teams and external partners (e.g., CDMOs) in a fast-paced environment to deliver against CMC milestones, ideally to enable IND filings, early clinical, and late-stage clinical activities to drive program expansion from Phase 1 to pivotal development for cell therapies in oncology.
- Strong understanding of CMC development & operations for cell and gene therapy or biologics, including: ○ Process development and technology transfer ○ Good Manufacturing Practices ○ Contamination management & remediation ○ Current regulatory and quality considerations
- Excellent organizational, problem-solving and communication skills with the ability to influence and drive decision-making.
- Experience leading Operational Excellence, process mapping and optimization.
- Proficiency in project management best practices and tools (e.g., Microsoft Project, SmartSheet, or equivalent)
- Familiarity with Agile or phase-gate project management methodologies.
- Strong analytical & problem-solving skills, with the ability to synthesize complex information into actionable insights.
- Exceptional interpersonal skills, including the ability to motivate teams, maintain positive working relationships with collaborators, influence without authority, and effectively resolve conflicts.
- Proven ability to manage multiple projects, take initiative, and work cross-functionally in a dynamic environment.
- Excellent written and verbal communication skills, with the ability to convey technical and strategic information (including the core elements of engineered T cell therapies) effectively to scientific and business audiences.
- Proven ability to identify risks proactively, prioritize tasks, and drive issue resolution.
- Proven success in goal setting, prioritization, and time management.
- Results-oriented, detail-oriented, and self-motivated, with the ability to work independently with minimal supervision.
- Thrives in a fast-paced, dynamic environment, adapting effectively to evolving priorities and ambitious timelines.
Qualifications (Preferred):
- PMP or equivalent project management certification is a plus.
- Experience in both early and late-stage clinical trials is a plus.
- Broader nonclinical and clinical development experience is highly advantageous.
- Familiarity with FDA regulatory processes and clinical trial management.
- Direct experience working on gene or cell therapy development programs, with recent cell therapy experience for oncology being particularly desirable.
The salary range is based on Outpace Bio's reasonable estimate of base salary for this role at the time of posting. Actual base salary will be based on a variety of factors including skills, experience, and other related factors permitted by law.
Working at Outpace offers an exciting opportunity to contribute to groundbreaking research that has the potential to transform the lives of people around the world.
Outpace Bio Total Rewards
Full time employees and their eligible dependents may enroll in Outpace's medical, dental, vision, life insurance, disability, flexible spending account, and 401k plan. In addition, employees may receive stock option grants to be outlined in their offer of employment and a performance bonus. Outpace employees enjoy flexible PTO, paid sick leave which complies with local requirements, and fifteen paid holidays plus a winter shutdown. Outpace also offers a generous paid parental leave policy to all regular full-time employees.
Outpace Bio is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
Applicants must be authorized to work in the United States. If you are legally authorized to work in the United States now, or in the future without any form of sponsorship, we encourage you to apply.
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The Company
What We Do
Outpace Bio is a venture-backed biotechnology company building a platform to create next-generation smart cell therapies. Our world-class scientific team is developing cell therapies that intervene in complex biology in ways that small molecules and biologics cannot. Our rich platform combines custom-designed biological functions with cellular control modalities that program the right response at the right time and place. We create mechanism-driven solutions tailor-made to dramatically improve efficacy and safety. Our partnership business model will accelerate the clinical validation of our platform and the development of truly curative therapies. We value teamwork, creativity, integrity, rigor, and passion for science.
At Outpace Bio, we believe that the highest performing teams include people from a wide variety of backgrounds and experiences who respectfully challenge each other. We are committed to building an open, diverse, and inclusive culture for all employees.
