Scientist I/II - Downstream Process Development (23-CMC02)
Boston, MA, USA
Posted on Friday, January 20, 2023
Come join our growing team as a Scientist in the Process Development group to help us bring our disruptive viral therapies from the lab to the patients who need them. We’re looking for an individual with demonstrated experience developing purification processes, transferring them to GMP manufacturing, and sustaining them throughout the drug development lifecycle. You should be excited about jumping in, getting hands-on, growing a company from the beginning, making a transformational difference for patients, and making big contributions to the inclusive culture we are building.
About the role:
- Demonstrated expertise in end-to-end purification and formulation of sterile, injectable, LVV-based gene therapy clinical trial materials.
- Mentor and build a talented purification development team to align with the needs of the organization over time.
- Plan and execute the technology transfer and scale-up of our processes at external partners.
- Enable the success of our clinical manufacturing campaigns by leading GMP manufacturing investigations and implementing process improvements.
- Prepare our early-stage processes for pivotal and commercial supply through scale-up and improving robustness.
- Evolve our platform process: Evaluate novel chromatography and filtration techniques in the lab to efficiently manufacture high purity products suitable for human use.
- Perform and supervise experimental planning, execution, analytical testing, analysis, and reporting.
- Author relevant CMC sections for regulatory submissions.
- Collaborate with Research, Upstream PD, and Analytical groups to achieve industry-leading purity and potency.
- Travel is required from time-to-time to support external development efforts on-site (10-25%).
- Degree in chemical engineering, biochemistry, or related field with relevant industry experience.
- Strong background in purification process development or MSAT, including lab-based work.
- In-depth understanding of principles of scale-up and how to design processes that are a fit for GMP manufacturing.
- Proven ability to work collaboratively, meet deadlines, and prioritize and flexibly balance multiple workstreams.
- Pragmatic problem solver with a get-it-done attitude.
- Excellent written and verbal communication skills, close attention to detail, and strong organizational skills.
- Knowledge of bioanalytical techniques (flow cytometry, ELISA, qPCR).
- Prior experience preparing health authority submissions preferred.
- Management, leadership, and/or mentorship experience preferred but not required.
Position ID#: 23-CMC02
To apply, please email email@example.com
Job Type: Full-time
Salary: commensurate with role and experience
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.