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Job Details

FormulationScientist

Company name
National Institutes of Health Office of Technology Transfer

Location
Baltimore, MD, United States

Employment Type
Full-Time

Industry
Sciences, Scientist, Chemistry

Posted on
Apr 10, 2021

Valid Through
Jul 24, 2021

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Formulation Scientist

KaloCyte, Baltimore, Maryland

Position Description:

KaloCyte is seeking a Formulation Scientist with experience in nanoparticle fabrication who can work independently and strategize with the Product Development Team. The individual will be tasked with pre‐formulation, formulation development, physico‐chemical characterization, and stability testing activities of ErythroMerTM, a bio‐synthetic nano‐formulated lyophilized artificial red blood cell. This role will be involved with scale‐up activities of ErythroMerTM to meet high levels of fabrication output necessary for larger animal studies while spearheading documentation of key manufacturing conditions as scale‐up occurs. As the design and manufacturing of ErythroMerTM is optimized, the individual will contribute to KaloCyte’s intellectual property portfolio.

Critical Skills/Expertise

Development of lipid‐based nanoparticulate delivery systems for macromolecules (e.g. proteins)

Lyophilization formulation and process development

Experienced with the regulatory requirements in the development of sterile drug delivery

systems

Analytical testing of drug products with emphasis on nanoparticulate systems (Size and Zeta

Potential using DLS, UV‐Vis, pH, KF titration, NMR, LC/MS)

Experience of working with blood‐based systems is a plus

Analysis of experimental data using statistical and mathematical methodology

Knowledge of cGMP documentation processes (such as protocols and SOPs), detailed

recordkeeping of experimental methods and results, and preparation of research reports

Knowledge/experience with QbD and DoE is desired

ICH stability testing of biologics

Independent troubleshooting of lab equipment

Identifying CPP (critical process parameters) and define process unit operation design

space/range

Job Location / Working Conditions

The KaloCyte Office and its laboratories are located in the UMB Center for Blood Oxygen Transport and Hemostasis, Health Sciences Facility III building and the UMB BioPark building, both in Baltimore, Maryland, fully equipped to carry out laboratory scale EM fabrication, benchmarking, and IND‐enabling research with potential exposure to blood, animals, biological, chemical and radioactive hazards. Must be physically able to wear protective equipment.

Benefits

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and benefits package including medical/dental insurance, 401K, 22 days of paid time off plus 6 sick days and 11 holidays.

Qualifications:

Education and Experience

Masters or PhD degree in chemistry, pharmaceutical sciences, or another relevant field.

4 years of post‐degree work, preferably in an industry setting, or equivalent experience.

Understanding of process manufacturing and scale‐up of production capabilities.

Ability to document fabrication processes and release testing and communicate to the rest of the team, with attention to regulatory requirements for CMC (Chemistry, Manufacturing, and Control).

Ability to collaborate with Product Development team, Affiliate/University team and company’s Co‐Founders.

Computer Skills

Strong proficiency with common office productivity systems including Adobe products, Microsoft Office (Word, Excel, PowerPoint, Outlook), and video conferencing (GoToMeeting, Zoom, etc.). Experience with DoE software/s is a plus. Salary competitive.

To Apply:

To apply for the position, please visit this website

Company info

National Institutes of Health Office of Technology Transfer
Website : http://www.nih.gov

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