Director, Analytical Development (Viral Vector/Cell Therapy)
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 CytoDRiVETM platform technology to express regulated therapeutic proteins to enhance anti-tumor activity. Obsidians’ lead program is currently in clinical development for the treatment of patients with metastatic melanoma and other solid tumors.
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 new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options.
The Director of Analytical Development is a key leadership role within our Technical Development and Manufacturing group and will be responsible for leading a team within Analytical Development. We’re looking for a leader to contribute to building Obsidian’s analytical sciences capabilities for process and product characterization, driving the development of the first autologous cell therapy product in our pipeline targeting cancer.
You’ll work collaboratively with the Analytical Development team as well as Manufacturing, Process Development, Regulatory, and Quality functions to develop analytical tools for the characterization of viral vectors and cell therapy products to support our clinical pipeline. As part of our Technical Development, Manufacturing, and Quality department, you’ll be a vital part of a highly collaborative team working to achieve Obsidian’s vision by translating innovative science into medical breakthroughs for 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.
Apply your expertise in developing, qualifying, and validating analytical assays to support the release and characterization of cell therapy product starting materials including viral vector, feeder cells, and ancillary materials in early and later phases of development.
Provide technical leadership to the team to develop, qualify and tech transfer assays to assess identity, purity, safety and potency of viral vectors (e.g. retroviral vectors) and other cell therapy starting materials.
Work closely with junior scientists to support their career growth and success in the lab, including mentoring on experiment design, data analysis with appropriate scientific rigor, and proper documentation in lab notebooks.
Author and review technical and scientific documents including but not limited to study protocols and reports, validation documents, SOPs, and test methods.
Recruit talent as needed and mentor/train team members on experiment design, data analysis with adequate scientific rigor, proper documentation in lab notebooks and reports.
Collaborate effectively with research, CMC team, partners and CDMOs/CTLs for establishment, qualification and validation of analytical methods to support development.
Act as subject matter expert and represent the analytical development function as needed for regulatory interaction and author relevant CMC sections in regulatory documents.
PhD in a relevant discipline (immunology, biochemistry, cell biology, biotechnology or related field).
Minimum 10 years relevant industry experience with prior direct experience in late-stage biologics, viral vectors and/or cell therapy preferred.
A track record with analytical development and method qualification validation supporting development of biologics (cell therapy, gene therapy, vaccines, antibodies…).
Subject matter expertise in product characterization methods relevant to an immune cell-based product and viral vector starting materials, with a focus on bioassays, molecular and immunoassay development (including cell-based assays, PCR / qPCR, ddPCR, sequencing, ELISA, MSD).
Strong troubleshooting, organization, and record keeping skills.
Experience working with CDMOs/CTLs for method transfer/development/qualification/validation.
Familiarity with FDA, ICH and EMA guidance documents relevant to gene and cell therapy analytical development and method validation.
Strong working knowledge of cGMP and quality systems requirements.
Ability to manage multiple responsibilities in parallel with minimal direction.
Prior experience managing functional teams and representing function in CMC teams.
A track record of leading teams to deliver critical goals while adapting to changing priorities.
A leadership style orientated to high standards and support to succeed and grow. You engage input of team members in problem solving and decision making and encourage open honest dialogue.
A desire and ability to work in an entrepreneurial, collaborative environment. You build healthy, productive and high trust relationships within your function and with direct stakeholders, and effectively influences actions and decisions.
Excellent oral and written communication skills.
A track record with analytical development and method qualification/ validation for characterization of engineered cell therapies or viral vectors.
A track record with analytical development and method qualification/validation supporting late phase development of biologics (cell therapy, gene therapy, vaccines, antibodies…).
Experience with multi-parameter flow cytometry assays, cell line/ primary cell transduction/ transfection, cytotoxicity assays.
Experience with biophysical assays such as chromatography methods and capillary methods such as HPLC, SPR, CGE, cIEF.
Experience with Design of Experiment (DOE) approaches and application to analytical development.
Experience authoring CMC sections of regulatory documents (IND/BLA) and engaging regulatory authorities.
Job level will be based on overall experience and capabilities
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.