Scientist/Senior Scientist - Biomarker and Assay Development
Omniox, Inc. is an IND-stage biopharmaceutical company developing a proprietary protein platform to treat diseases where hypoxia and ischemia drive poor clinical outcomes, such as cancer, stroke and critical care. Omniox has strong financial sponsorship from leading investors.
We are looking for a highly motivated Scientist / Senior Scientist with relevant experience in biomarker identification, development and validation of assays, and overseeing the implementation of validated assays in pre-clinical and clinical studies in the areas of oncology, immunology and hypoxia. The Biomarker and Assay Development Group works with research and clinical teams to design clinical biomarker and patient characterization strategies, develops and implements clinical biomarker assays to deliver high quality biomarker, PK, immunogenicity, and patient characterization data to support programs from research and pre-clinical stages through early and late stage clinical development.
We seek candidates with extensive lab experience and knowledge of multiple technology platforms for cell-, protein-, and nucleic acid-based assays to lead the development of clinical assays and outsourcing of finalized assays to clinical testing labs. This person will work with both internal groups and outside contract organizations to ensure timely development and implementation of clinical biomarker assays. The preferred candidate will have a strong scientific biology background to enable understanding of disease and drug mechanisms supporting assay development and use.
Job title will be determined based on the level of experience.
As an Omniox team member, you will support our corporate values of:
- Scientific and operational excellence
- Open-mindedness and courage
- Collaborate with internal research and clinical groups in order to:
- identify biomarkers and to develop assays for predictive and pharmacodynamic assays.
- support centralization of biochemistry and clinical manufacturing assays.
- ensure timely identification of required assays, execution of assay development, transfer and outsourcing.
- Design, execute and analyze development and validation protocols.
- Transfer assays internally; develop, optimize and validate assays on multiple platforms.
- Interact with contract organizations to outsource assays to support pre-clinical activities and for clinical trials execution.
- Interact with external collaborators and vendor during the development and optimization of assays.
- Present biomarker data internally and externally.
- Assist in the development and maintenance of processes, standard operating procedures, validations, and associated documentation.
- Maintain awareness of regulations and guidance for assay development, validation, and implementation.
- Additional responsibilities include:
- Design control
- GLP and GCP compliance, including documentation of compliance
- Ability to cover R&D, pre-clinical, and clinical assay requirements
- Ph.D. in life sciences with a biology background in oncology, immunology, or hypoxia
- Experience with clinical biomarker assay development
- 5+ years of experience, preferably in the biotechnology or pharmaceutical setting
- Good bench skills and familiarity with design-of-experiment (DOE) approaches and data analysis tools.
- Experience with multiple technical platforms, including immunohistochemistry, flow cytometry, ELISA, PCR, Nanostring, Luminex, and next generation sequencing
- Relevant industry experience in and understanding of drug and/or diagnostic test development with experience in CLIA and or FDA regulated environments, design control and GLP/GCP
- Experience with outsourcing and contract research organization management is highly desirable
- Strong organizational skills, attention to detail, ability to work independently
- Excellent written and verbal communication skills and demonstrated ability to build relationships and act as liaison with partners on drug development matters.
- Prior responsibility and accountability for developing and validation complex assays is highly desirable.
- Well-developed critical reasoning skills and in risk management assessments.
We offer competitive compensation, including base salary + bonus, stock options, health benefits and paid time off.
Please send your resume and cover letter to firstname.lastname@example.org
Omniox is an equal opportunity employer. Wewill consider all qualified applicants without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.