SR. SCIENTIST, FORMULATION & DRUG PRODUCT DEVELOPMENT

Company: Kelonia Therapeutics
Location: Boston
Posted on: October 19, 2024

Job Description:

Here at Kelonia Therapeutics, we aren't just a preclinical company; we're trailblazers in viral engineering, pushing the boundaries of in vivo lentiviral gene and cell therapy. We're not just a team; we're dreamers on a mission to bring the promise of cell and gene therapy to every patient in need.
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At Kelonia, we've gathered a group of pioneers in cell and gene therapy to lead our journey, with extraordinary scientific founders at the helm, providing the cutting-edge technology that sets us apart. We're not just building a company; we're cultivating a culture-one that values both skill and care.Are you ready to be a part of our remarkable journey? We're looking for someone exceptional to join our growing team as a Sr. Scientist, Formulation & Drug Product Development in the Technical Development Operations group. This isn't just a job; it's an opportunity to contribute to groundbreaking therapies, to be part of a company's inception, and to make a transformative impact on patients' lives. If you're passionate about scaling a company from the ground up, making a real difference, and shaping the inclusive culture we're proud of, this opportunity is tailor-made for you. Join us and be a driving force in achieving excellence in viral engineering.What You'll Do:

• Lead the formulation development of lentiviral vectors, including the design, optimization, and scale-up of LVV formulations
• Develop, transfer, and scale-up Drug Product manufacturing processes.
• Conduct stability studies to ensure the integrity and efficacy of lentiviral formulations over time
• Collaborate with cross-functional teams, including R&D, Analytical Development, External Manufacturing, Clinical Development, and quality assurance, to ensure seamless project progression
• Utilize advanced analytical techniques to characterize lentiviral formulations, including particle size, titer, and potency assays
• Troubleshoot and resolve formulation and process-related challenges to ensure consistent production and quality of lentiviral vectors
• Prepare and review technical documents, including study protocols, reports, and regulatory submissions
• Stay current with industry trends, emerging technologies, and regulatory guidelines related to viral vector formulation and gene therapy
• Mentor and provide technical guidance to junior scientists and team membersWhat You'll Bring:
  • Strong scientific expertise in Biochemistry, Pharmaceutical Sciences, or a related field.
  • Experience with parenteral formulation development, viral vector formulation strongly preferred
  • Knowledge of biopharmaceutical manufacturing processes and regulatory requirements for gene therapy products
  • Experience with technology transfer, scale-up, and support of GMP manufacturing
  • Familiarity with analytical techniques used for viral vector characterization, such as qPCR, ELISA, flow cytometry, and particle sizing
  • Strong communication and interpersonal skills, with the ability to work effectively in a collaborative team environment
  • Proven track record of scientific publications and/or patents in the field of viral vector formulation or gene therapy is a plusOur goal at Kelonia is to promote a healthy work/life balance and we hope the benefits we provide are a direct reflection of that goal. We offer a hybrid workplace that provides employees with flexibility to work in the office or remotely dependent on job responsibilities. *We also offer a team-focused environment with a top-notch benefits package (health, dental, flexible PTO, and commuter) to match. Kelonia fosters a collaborative and inclusive workplace that allows you to become a part of a small team that places equal value on talent development and meeting company goals.Kelonia Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Kelonia does not accept unsolicited resumes from any source other than directly from candidates.
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Keywords: Kelonia Therapeutics, Plymouth , SR. SCIENTIST, FORMULATION & DRUG PRODUCT DEVELOPMENT, Other , Boston, Massachusetts