NIH SOAR - CC- Biologist

Overview:

Axle Informatics is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations around the globe. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).

Responsibilities:

Deliverables

Work products and documents related to performing manufacturing of novel cellular therapy products, including cellular therapy and chimeric antigen receptor T cells; organize records forms and labels necessary for HCT/P manufacture. - Ad-Hoc

Work products and documents related to performing trouble shooting during HCT/P manufacturing and assay performance; document actions required to resolve problem and initiate corrective action; perform required quality control steps as outlined in SOPs; perform data retrieval and entry using multiple IT systems. - Ad-Hoc

Work products and documents related to interpreting experimental techniques and procedures; reports on laboratory results, written evaluation of procedures including detected deficiencies/defects, and reports on cellular therapy products and research protocols. - Ad-Hoc

Work products and documents related to maintaining up-to-date knowledge of regulatory requirements; attend weekly CPS staff meetings or review minutes of the meeting if unable to attend. - Ad-Hoc

submission schedules and SRT member presentations, organizing scientific presentation preparation and virtual recordings. - Ad-Hoc

Work details and description:

Perform manufacturing of novel cellular therapy products, including cellular therapy and chimeric antigen receptor T cells 1

Organize records forms and labels necessary for HCTP manufacture 2

Perform trouble shooting during HCTP manufacturing and assay performance; documentations required to resolve problem and initiate corrective action as needed 3

Perform required quality assurance steps as outlined in SOPs

Perform data retrieval and entry using multiple IT systems

Perform cleaning of biosafety cabinets, equipment and supplies

Interpret experimental techniques and procedures; prepare reports on laboratory results

Prepare written evaluation of procedures including detected deficiencies defects, and reports on cellular therapy products and research protocols

Critically evaluate laboratory data presentations

Perform validation studies on equipment, facilities, and processes

Perform experiments to validate novel manufacturing techniques

Document product manufacturing data in compliance with Good Documentation Practices GDP

Inventory and order supplies with NIH approval for clinical manufacturing

Maintain up-to-date knowledge of regulatory requirements as defined by current version of CPS Drug Master File, applicable sections of FDA Code of Federal Regulations and current edition of AABB Standards for Cellular Therapy Product Services; regularly review CPS PSI and SOP manuals to stay current with procedural revisions

Attend weekly CPS staff meetings or review minutes of the meeting if unable to attend

Independently prepare drafts of executive briefing documents/presentations; gather, organize, and summarize selected information; prepare presentation slides to comply with Institute and conference formats.

y)1, 2, 3, 4, 5 represents priority rankings, where 1 is highest priority and 5 is lowest priority of those ranked

Qualifications:

Education:

Certifications & Licenses

Ph.D. in Medical Technology, Biology, Life Sciences or a related discipline.

Benefits

Axle will commit to match the incumbent's annual salary (no wage reduction)

Hiring Bonus ($5K)

100% Medical, Dental & Vision premium coverage for Employees

Paid Time Off (Including Holidays)

Employee Referral Bonus

401K Match

Tuition reimbursement and professional development opportunities

Flexible Spending Accounts: Healthcare (FSA)

Parking Reimbursement Account (PRK)

Dependent Care Assistant Program (DCAP)

Transportation Reimbursement Account (TRN)

The diversity of Axle's employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment-based age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.

Accessibility: If you need an accommodation as part of the employment process please contact:

Email: (url removed)

Disclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individual's assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.