Senior Scientist, Analytical Strategy

Kelonia Therapeutics

Kelonia Therapeutics

Boston, MA, USA
Posted on Saturday, April 13, 2024
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.
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 are looking for someone exceptional to join our growing team as a Senior Scientist in the Analytical Strategy 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:

  • Manage the relationship between Kelonia and external QC departments in collaboration with Technical Operations to enable release and stability testing of GMP LVV for our lead candidate
  • Author and maintain specifications, specification justifications, and stability protocols
  • Support review and approval of method transfer, qualification and validation protocols and reports
  • Support authoring and review of CMC sections of INDs
  • Support development of assay lifecycle management strategy and support process control strategy as a part of product lifecycle management for our lead candidate and platform improvements, including support for analytical comparability for process changes
  • Mentor junior staff, including; technical writing, assay design, results interpretation, presentation preparation, and in-lab troubleshooting
  • Support the development (improve sensitivity, specificity, and robustness) and qualify analytical methods to release and characterize Kelonia’s injectable gene therapy products
  • Support authoring and maintenance of analytical procedures and ensure cross-functional training and implementation
  • Author development reports and support authoring and execution of qualification and validation protocols of analytical methods
  • Partner with internal stakeholders to develop and implement an extended product characterization strategy, including; consulting on discovery, designing, executing and interpreting assays for characterization and in-process testing
  • Prepare and present data and interpretations to cross-functional stakeholders
  • Serve as subject matter expert in collaborative development and tech transfer of analytical methods between internal stakeholders and external AD and QC organizations

What You'll Bring:

  • Strong scientific expertise in Pharmacology or related discipline, PhD, and non-PhD candidates encouraged to apply (level based on experience).
  • Ability to communicate effectively with internal and external stakeholders (including collaboration partners and CTOs)
  • Experience writing and revising specifications, specification justifications, SOPs and writing and executing protocols and reports for non-GMP activities in support of regulatory filings and/or process changes is preferred
  • Excellent organizational and documentation skills
  • Experience in managing GMP stability is preferred
  • Experience in managing external QC operations is a plus
  • Experience with assay qualification and validation, including; pre-qualification work, developing methods, method optimization, and standard and control identification, generation, banking, and qualification is preferred
  • Experience developing and optimizing cellular assays (examples: MSD/Luminex/ELISA, multicolor flow cytometry) and/or molecular assays (examples: qPCR/PCR/ddPCR) is preferred
  • Must work collaboratively, meet deadlines, and prioritize multiple workstreams according to group/company goals
Our 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.