Analytical Scientist

DISCGENICS INC•Salt Lake City, UT

1d•Onsite

About The Position

DiscGenics is a pioneering, late-clinical stage biopharmaceutical company focused on regenerative cell-based therapies for degenerative diseases of the spine. We are dedicated to improving lives by alleviating pain and restoring function through innovative treatments. Our team is driven by a relentless pursuit of excellence and guided by core values of Integrity, Innovation, Accuracy, Teamwork, and Stewardship. We are seeking a talented and dedicated Analytical Scientist to join our team and contribute to our mission of revolutionizing patient care.

Requirements

Bachelor’s degree in biological sciences, biochemistry, chemistry, cell biology, or a related field with 7-10+ years of relevant industry experience, OR Master’s degree in a related field with 5-8+ years of experience, OR PhD in a related field with 2-5+ years of experience.
10+ years of experience preferred, particularly within GMP/CMC or other regulated environments and spanning development through commercialization.
Experience supporting clinical and commercial development of pharmaceutical, biological, or cell therapy products, including scale-up to commercialization.
Hands-on experience with analytical method development (e.g., immunoassays, multi-parameter flow cytometry, cell-based potency assays) in a QC or regulated setting preferred.

Nice To Haves

Hands-on experience with analytical method development (e.g., immunoassays, multi-parameter flow cytometry, cell-based potency assays) in a QC or regulated setting.

Responsibilities

Design, develop, optimize, qualify, validate, and execute analytical methods for product characterization and release.
Lead and/or support development of cell-based bioassays, potency assays, immunophenotyping, and multiplexed protein assays.
Perform routine testing to support development studies and clinical batch release.
Track, trend, and statistically analyze data to evaluate method performance and support specification setting.
Advance analytical methods from concept through qualification and transfer to Quality Control and external partners.
Apply Quality by Design (QbD) and Design of Experiments (DOE) principles to method development.
Support scale-up and commercialization of analytical methods.
Manage outsourced testing activities when needed.
Collaborate cross-functionally with Process Development, Manufacturing, and Quality teams.
Present scientific data and serve as subject matter expert (SME) for analytical methods.
Lead or mentor junior scientists and assist in training on analytical methods.
Support and contribute to departmental and organizational initiatives.
Maintain, calibrate, and operate laboratory equipment and instrumentation.
Ensure proper documentation and organization of experimental data.
Participate in equipment qualification and upkeep.
Contribute to risk assessments, comparability studies, and specification justifications.
Perform other duties as required.