Associate Director, External Manufacturing

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.

The Associate Director, External Manufacturing will provide management and comprehensive oversight for external manufacturing activities related to Outpace's innovative autologous T-cell therapies and lentiviral vectors. This critical role involves managing Contract Development and Manufacturing Organizations (CDMOs), supporting technology transfers and maintaining strict compliance with global regulatory standards. The successful candidate will collaborate closely with internal cross-functional teams and external manufacturing partners to implement scalable and efficient manufacturing strategies and ensure programs are efficiently transferred from development to manufacturing. Responsibilities include managing CDMO relationships, Person-in-Plant (PIP) during manufacturing, reviewing manufacturing documentation and records, authorship and review of CMC content in regulatory submissions, and ensuring timely delivery of drug products to support Outpace's clinical trials. The ideal candidate will have expertise in gene-modified allogeneic and/or autologous cell therapy and lentiviral vector manufacturing, a proven track record in managing external manufacturing networks, experience in authoring regulatory submissions and demonstrated ability to drive successful operational outcomes. The position reports to the Head of Technical Operations and Quality, and is located Seattle, WA.

Responsibilities (Position responsibilities may include, but are not limited to):

• Manufacturing Operations:
• Manage external GMP manufacturing operations for T-cell therapies and lentiviral vectors, ensuring compliance with regulatory standards.
• Support development of external manufacturing capabilities, facilities, and infrastructure to ensure seamless production workflows.
• Manage relationships with CDMOs, ensuring alignment with quality, cost, and timeline requirements.
• Contribute to investigations and CAPAs.
• Contribute to contract and agreement negotiations, as needed.
• Collaborate with Clinical Development and Quality teams to ensure timely delivery of drug product to support the clinical manufacturing schedule.
• Technology Transfer:
• Support technology transfer of developed processes to external CDMOs, ensuring compliance with regulatory requirements and internal quality standards.
• Collaborate closely with Process Development, Analytical Development, Quality and Regulatory teams to enable seamless and compliant transition from development to GMP manufacturing.
• Support development of comprehensive technology transfer documentation, including process flows, Standard Operating Procedures, batch records, and training materials.
• Strategic Leadership:
• Execute strategic plans for manufacturing operations, aligning with corporate goals, clinical development milestones, and commercialization strategies.
• Execute continuous improvement initiatives to enhance productivity, quality, cost-effectiveness, and operational scalability.
• Act as a technical subject matter expert representing manufacturing and CMC in internal/external cross-functional meetings
• Quality and Regulatory:
• Ensure strict adherence to phase appropriate GMP guidelines, quality standards, and regulatory requirements across all manufacturing activities.
• Support implementation of quality systems, validation programs, and risk management strategies to ensure consistent product quality and safety.
• Serve as a primary author and reviewer of CMC content for all regulatory submissions and responses to regulatory inquiries.
• Supply Chain and Logistics:
• Contribute to robust supply chain strategies to ensure continuous, reliable sourcing of critical raw materials and components.
• Support effective logistics and distribution strategies to support global clinical trials and eventual commercialization.

Qualifications (Required)

• Ph.D., M.S. or B.S. degree in Biology, Chemistry, Bioengineering, Biotechnology, or a related Life Sciences discipline. Ph.D preferred.
• Minimum of 8 years of progressive experience in biopharmaceutical manufacturing or related technical role, including at least 5 years managing external manufacturing.
• Experience with GMP manufacturing operations for autologous and/or allogeneic T-cell therapies, including CAR-T or TCR-T, and lentiviral vector processes, is essential.
• Proven success in managing external manufacturing operations.
• Demonstrated ability to manage complex manufacturing networks, supply chains, and external partnerships.
• Prior experience interacting with regulatory agencies and managing regulatory inspections and submissions.
• Prior experience authoring and reviewing CMC content for INDs, CTAs and related regulatory submissions.
• Comprehensive understanding of regulatory requirements (FDA, EMA, ICH) applicable to cell therapy manufacturing and compliance.
• Exceptional leadership, interpersonal, organizational, and communication skills, with the ability support strategic planning and influence stakeholders at all levels.
• Demonstrated capability to manage and prioritize multiple projects effectively and efficiently.
• Ability to travel to external manufacturing sites in support of tech transfer and/or manufacturing activities

$157,000 - $185,000 a year

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.