Senior Manager, Sample Testing Core: Analytical Development
Bedford, MA
About Us
Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering from solid tumor malignancies. Obsidian's programs apply our cytoDRiVE platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. We're currently investigating our lead program OBX-115 and enrolling patients in an ongoing clinical trial in advanced or metastatic melanoma.
We're proud of our diverse talented team and committed to cultivating an environment where each person feels a strong sense of belonging and is supported to continuously learn and contribute their best work. Our research team is based in the heart of Cambridge, MA, and our Technical Development, Manufacturing & Quality team is based in our facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
On April 3, 2024, we announced closure of a significantly oversubscribed $160.5 million Series C financing with a top-tier syndicate of life science investors led by new investor, Wellington Management. Proceeds from the financing will advance Obsidian's lead program in its ongoing trials. We're focused on enrolling patients and reaching key clinical and regulatory milestones, as well as manufacturing scale-up ahead of pivotal trial readiness.
Our Opportunity
We're looking for a highly motivated Senior Manager with a strong background in organizing and managing an Analytical Sample Testing Core to help drive the development of multiple cell therapy products in our pipeline targeting cancer. As part of our Technical Development and Manufacturing department you will be a vital part of a highly collaborative team working to achieve the Obsidian's vision by translating innovative science into medical breakthroughs for patients, starting with our lead program cytoTIL15 engineered to make TILs more effective for more patients.
This is a unique opportunity to be a contributor in a well-funded clinical company with blue chip investors, field-leading advisors, best-in-class partners, and an experienced team. You'll help us build a dynamic, innovative, passionate, collaborative, and successful organization focused on delivering transformative therapies in areas of greatest clinical need.
You Will
- Apply your expertise in managing assays to support the release and characterization of viral vector starting materials, critical raw materials and cell therapy products for early and late phase clinical trials.
- Plan and manage experiments in coordination with the Process Development and Analytical Development teams, working both independently and as part of a multidisciplinary team of researchers.
- Manage a core sample testing group within the Analytical Development team.
- Demonstrated track record of utilizing data tracking/managing tools to effectively manage timelines and trend data.
- Support data management and tracking of projects.
- Support introduction of new analytical technologies, implementation of common reagents and controls, trending of data, and transfer of analytical methods into the sample team.
- Interpret results, troubleshoot technical hurdles, and propose solutions to the team.
- Maintain excellent records of experiments, including Electronic Notebook entries.
- Author and review technical and scientific documents including but not limited to study protocols and reports, SOPs and test methods.
- Collaborate effectively across Obsidian organization, present internally to project teams, management, and scientific teams.
You Bring .
Core Qualifications
- Master's and 7+ years of relevant industry experience or a Bachelor's and 10+ years of relevant industry experience.
- Expertise in managing Core Testing or Production teams.
- Experience with a variety of assays such as multi-parameter flow cytometry assays, molecular assays (ddPCR, qPCR), ELISA assays, cell line/ primary cell transduction/ transfection, and cell-based assay development
- Strong troubleshooting and communication skills, highly organized with strong record-keeping and an ability to multi-task.
- Highly collaborative working style and ability to adapt in a fast paced, rapidly developing environment.
- Ability to work with minimal direction to meet objectives and timelines, adapting to changes and priorities to fulfill our mission.
Bonus Qualifications
- Demonstrated track record supporting multiple teams within an organization with testing requirements and strategies.
- Experience with Design of Experiment (DOE) approaches and application to analytical development.
- Familiarity with FDA and EMA guidance documents relevant to gene and cell therapy analytical development and method validation.
Obsidian is proud to be an equal opportunity employer, cultivating a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.