Bio Manufacturing Jobs in Bothell, WA (NOW HIRING)

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.
Key Responsibilities (position responsibilities may include, but are not limited to):

• Serve as study clinical scientist on oncology cell therapy trials to partner closely with Senior Medical Director in the execution of the clinical development strategy for assigned asset(s), actively participating in study start-up activities, asset team meetings, safety monitoring committees, and coordination of patient enrollment and dosing with product manufacturing/delivery managed by technical operations and clinical operations.
• Conduct review of emerging clinical and medical data to ensure quality data; review and query data; present and discuss relevant data to appropriate teams and relevant stakeholders.
• Collaborate on the preparation and review of clinical protocols and amendments and support the development of other critical study and regulatory documents including informed consent forms, investigator brochures, statistical analysis plans, regulatory documents, annual reports, and clinical study reports (CSRs).
• Support clinical development activities during implementation of clinical database with CRO.
• Review risks, query resolution, and protocol deviations. Support and assist in the development of publications, abstracts, and presentations.
• Develop effective collaborations with key internal and external partners, such as cross functional team members, consultants, asset team leaders, and clinical trial site staff.
• Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors.
• Participate in project teams to help implement clinical development and contribute to key milestones (e.g., start-up and delivery of POC trials).

Required Qualifications:

• Bachelor's degree or advanced degree (MSc, PharmD, MD, PhD) in Life Sciences, Pharmacology, or related field.
• Minimum of 3 years' experience in conducting / supporting oncology/hematology clinical studies; experience in early phase development and/or cell therapy preferred.
• Excellent written and verbal communication skills.
• Experience with interpretation of clinical research results including safety and efficacy required. Familiarity with statistical principles is desirable.
• Ability to think strategically and tactically with an interest in clinical research and drug development with a focus on delivering results and driving innovation.
• Ability to adapt and problem-solve in an agile, fast-paced, start-up, team-based matrix environment as well as the ability to function independently as appropriate. Flexible to accommodate changes in team and project needs.
• Ability to handle multiple projects at a time and have strong attention to detail while understanding the higher-level strategy.
• Passion for developing complex, innovative medicines for solid tumors.

$226,000 - $267,000 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, health savings account, commuter benefits, legal benefits, and 401k plan which includes an employer match. 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.
Outpace Bio does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Outpace Bio or its employees is strictly prohibited unless contacted directly by Outpace Bio's internal team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Outpace Bio and will not owe any referral or other fees.