Senior Scientist/Principal Scientist, Analytical Development at Obsidian Therapeutics

Bedford, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

04 Feb, 26

Salary

201500.0

Posted On

06 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Development, Cell Therapy, Biologics, Product Characterization, Molecular Techniques, cGMP, Quality Systems, Flow Cytometry, Transduction, Transfection, Technical Support, Collaboration, Experiment Design, Troubleshooting, Documentation, Communication

Industry

Biotechnology Research

Description

About Us… Obsidian Therapeutics is pioneering engineered cell and gene therapies to deliver transformative outcomes for patients. Obsidian’s programs apply our CytoDriveTM technology in Cell and Gene therapy products to control expression of proteins for enhanced therapeutic efficacy and safety. Obsidian’s lead program is currently in preclinical 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 of inclusion 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 Technical Operations team is based in our brand-new facility in Bedford, MA. Obsidianites enjoy a highly collaborative culture, competitive salary and benefits, and potential for ownership through stock options. Our Opportunity… 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. You Will… 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. You Bring… 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 Experience with multi-parameter flow cytometry assays, cell line/ primary cell transduction/ transfection 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 Obsidian is committed to equitable and transparent pay practices. The anticipated base salary range for this role is below. The actual base salary offered will be determined based on a combination of factors, including applicable qualifications, level of education, the depth of experience, unique skills, geographic location, internal equity, and/or business needs. The actual base salary offered will be in accordance with federal, state, and/or local wage requirements for the role’s location. Our competitive compensation package includes an annual incentive bonus as a percentage of actual base salary and long-term incentives in the form of employee stock options, both of which are commensurate with the role’s level. We also offer a generous benefits package which includes comprehensive medical, dental, and vision coverage; company contributions to health savings and retirement accounts; ample paid time off; access to wellness programs; and rich career growth opportunities. First Level $144,000—$176,000 USD Second Level $165,000—$201,500 USD 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.

Responsibilities

Lead critical workstreams to build analytical capabilities for TIL products and viral vectors. Collaborate with various teams to develop analytical tools for characterization to support the clinical pipeline.