Senior Scientist/Principal Scientist, Analytical Development

Obsidian Therapeutics•Bedford, MA

45d

About The Position

We are looking for a highly motivated Senior or Principal Scientist to join our Analytical Development team within Technical Operations. This person will be responsible for leading critical workstreams to build Obsidian's analytical capabilities for TIL product and viral vector, driving the development of the first autologous cell therapy product in our pipeline targeting cancer. You'll work collaboratively within the Analytical Development team, partnering with Process Development, Regulatory, and external CDMO partners to develop analytical tools for the characterization of viral vectors and cell therapy products to support our clinical pipeline. You will play a vital role in shaping Pivotal TIL and Vector analytics, strengthening CMC pivotal readiness, post pivotal start, as well as leading TIL and Vector analytical characterization at partner CDMOs.

Requirements

PhD in a relevant discipline (molecular biology, immunology, biochemistry, cell biology, virology or related field) with a minimum of 5+ years relevant industry experience including prior direct experience in retroviral and/ or lentiviral vector and cell therapies development with a progressive track record of leadership and impact
A track record in analytical development supporting late-stage development of cell therapy and/or biologics
Expertise in product characterization methods relevant to immune cell function (including cell-based potency assays, biomarker expression and function; ELISA, MSD, and flow cytometry)
Demonstrated knowledge of retro-viral vector characterization using molecular techniques (titration assays, PCR / qPCR, ddPCR, sequencing)
Experience working with CDMOs/ CTLs for method transfer/development/qualification/ validation and method life cycle management
Strong working knowledge of cGMP and quality systems requirements
Prior experience managing functional teams and external CDMO partners
Excellent oral and written communication skills
Self-motivation, with a proven ability to manage multiple responsibilities in parallel with minimal direction
Scientific rigor in designing and executing experiments and record keeping
Flexibility - you adapt to change in a fast paced, rapidly developing environment
A Collaborative and accountable workstyle - you recognize that success requires teamwork and interdisciplinary thinking; you share feedback and ideas to facilitate better outcomes
Curiosity and humility - you seek and welcome input/expertise of others; you're a continuous learner
Tenacity and resilience - you're not easily overwhelmed by challenges, and deliver on commitments

Nice To Haves

Experience with multi-parameter flow cytometry assays, cell line/ primary cell transduction/ transfection

Responsibilities

Drive internal and external TIL process characterization studies to enhance TIL product understanding.
Design, plan, and execute experiments in Analytical Development, working both independently and as part of a multidisciplinary team of researchers.
Support ongoing vector characterization at the Central Test Lab as the SME.
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, validation documents, SOPs, and test methods.
Act as a subject matter expert to represent the analytical development function as needed for regulatory interaction and author relevant CMC sections in regulatory documents.
Collaborate effectively across Obsidian organization and CDMOs/CTLs, present internally to project teams, management, and scientific teams.
Provide technical support to internal and external analytical operations.

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