120 applicants

Company

Original Job Post

Turnstone Biologics · 2 days ago

Senior Scientist, Quality Control

California, United States

Full-time

Onsite

Senior Level

7+ years exp

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Responsibilities

Contribute to and implement QC method qualification and validation strategy in collaboration with Analytical Development. Accountable and responsible for implementing the detailed method qualification and validation strategy with key stakeholders.

Technical review and approval of method qualification/validation protocols and reports, transfer protocols and reports, and stability reports.

Technical review and approval of executed test methods at the CDMO and ensure they meet the requirements of Turnstone’s process and regulatory guidelines.

Support timely and accurate documentation in support of the various Quality records (laboratory investigation, deviations, impact assessments, CAPAs, change controls).

Provide hands-on technical support to laboratory investigation, deviations, non-conformance events, and ensure batch disposition decisions are guided by sound technical rationale.

Collaborate in cross-functional teams to support, execute and/or provide oversight in the execution of method optimization, extended characterization, troubleshooting, transfer, and qualification/validation.

Develop, revise, review, approve, and own SOPs (Standard Operating Procedures) and technical (transfer, validation, bridging, etc.) protocols/reports.

Assist in reviewing data and assist with product and assay control trending and monitoring.

Cultivate a team culture of high standards, collaboration, empowerment, and trust.

Additional duties as assigned.

Qualification

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Drug developmentFlow cytometryELISA/ELLACell counterQPCRDdPCREndotoxinSterility testingMethod transferMethod verificationMethod qualificationMethod validationQC environmentScientific data analysisGraphPad PrismFlowJoFACSDivaNovocyteSpotfireJMP softwareTechnical writingRegulatory environmentProtocolsSOPsQuality standardsProject managementResource managementTurnstone Biologics cultureProblem-solvingResilience

Required

Bachelor’s or Master’s degree with demonstrated experience in cell therapy, immunology, cancer biology or a closely related field, and 7+ years of industry experience, preferably in gene and cell therapy.

Experience with different phases of drug development

Experience with relevant technologies on flow cytometry, ELISA/ELLA, cell counter, qPCR, ddPCR methods, endotoxin, sterility testing (e.g. BacT/alert).

Experience and successful track record of method transfer/verification/qualification/validation, routine testing in QC environment.

Knowledge related to scientific data analysis applications such as GraphPad Prism, FlowJo, FACSDiva, Novocyte, Spotfire, and JMP software packages.

Excellent technical writing experience in a regulatory environment (such as protocols, reports, and SOPs).

Implementation of 'best practices' or leading-edge quality standards.

Project Management skills, including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management.

Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

Highly effective organization, written, and verbal communication skills to address a wide variety of audiences and governing bodies.

Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving skills in various situations.

Leads by example to foster Turnstone Biologics culture.