Apply on Employer Site

DiscGenics · 5 months ago

Senior Scientist, Analytical Sciences

Salt Lake City, UT, US

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

DiscGenics is a pioneering biopharmaceutical company focused on advancing regenerative cell-based therapies for patients with degenerative spine diseases. The Senior Scientist, Analytical Sciences will develop and qualify analytical methods, evaluate new technologies, and author regulatory documents, while collaborating with various teams to ensure quality and compliance in their innovative therapeutic processes.

BiotechnologyHealth CareLife ScienceTherapeutics

Responsibilities

Manage strategic, SME, technical, and scientific development related to biological assays and other critical analytical methods

Advance and implement cell-based bioassay/potency and immunophenotyping by multi-parametric flow cytometry methods from conception through optimization, qualification, and method transfer to Quality Control and external partners as part of an analytical control strategy and to support Process Development

Employ quality by design (QbD) and design of experiment (DOE) approaches to method development to quickly identify operating regions within phase-appropriate pre-defined acceptance criteria aimed to meet ICH guidelines

Work with Process Development, implementing and documenting analytical methods as part of experimental study plans to progress and characterize novel engineered cell therapy platforms

Work with Quality partners to draft study protocols, qualification reports, change controls, and occasionally perform routine assays as QC personnel for drug product release and characterization

Write, review, and edit accurate technical and development reports, CMC sections for regulatory submissions, and SOP/maintenance/user requirements for relevant equipment platforms

Provide technical guidance to junior staff, assign tasks, review data, and strengthen regulatory concepts (cGMP)

Participate in group and department meetings, present scientific data, and provide expertise in areas of responsibility

Maintain, calibrate, and operate analytical equipment and instrumentation that is used in the execution of assays

Author quality records (change controls, deviations, investigations) to implement method changes and/or to investigate non-conformances, OOS/OOT, and CAPA

Author/contribute to other technical reports, including but not limited to comparability protocols/reports, risk assessments, and justification of specification, etc

Others duties as required

Qualification

Cell-based bioassaysAnalytical method developmentFlow cytometryRegulatory submissionsQuality by design (QbD)Design of experiments (DOE)ImmunoassaysTeam leadershipMicrosoft OfficeCommunication skillsProblem-solvingTime management

Required

Demonstrated knowledge of Process Development or cellular therapy products and Analytical Method Development within a regulated environment

Experience with bioassay analytical science methods

Strong interpersonal, communication (verbal and written), and organizational skills

Independence and creative problem-solving abilities

Ability to handle highly confidential business information

Exceptional time management and multi-tasking skills

Team leadership skills and team player

Adheres to and leads with the Company Values of Integrity, Innovation, Accuracy, Teamwork and Stewardship

Regular and predictable attendance

Ability to report to work responsive, free from sedatives, and in a non-sedative state

Proficient with Microsoft Office, including Word, Excel, and PowerPoint

Advanced degree in biological, biochemical, chemistry, cell-biology, or related field

10+ years of relevant industry experience, preferable prior GMP roles for CMC

Experience with commercial development of pharmaceutical, biological or cell therapy product

First-hand experience in development and qualification of immunoassays, multi-parameter flow cytometry, and cell-based potency methods for release in a QC/regulated environment

Must have experience with scale-up to commercialization