Associate Formulation Scientist

KaloCyte, Inc.; Baltimore (MD); On-site; USD 55,000 - 65,000; Full time

Job summary

KaloCyte, Inc. is seeking an Associate Formulation Scientist to support their R&D team in formulating and testing a novel bio-synthetic red blood cell product. The role involves hands-on fabrication, stability assessments, analytical methods, and collaboration within a dynamic lab environment. Ideal candidates will have relevant degrees and experience in drug development.

Benefits

Medical, dental and vision insurance

401k with matching

20 days of paid time off

6 sick days and 13 holidays

Qualifications

• Minimum 1-year industrial experience for Master’s; minimum 2 years for Bachelor’s.
• Ability to collaborate with teams and communicate results effectively.
• Experience in glove box under inert atmosphere is a plus.

Responsibilities

• Fabricate and assess the stability and characteristics of EM.
• Perform analytical tests and support research studies.
• Manage data and prepare documentation for laboratory work.

Skills

Collaboration

Data analysis

Technical writing

Communication

Education

Master’s degree in Pharmaceutical Sciences or analytical chemistry

Bachelor’s degree in chemistry or related field

Tools

GraphPad Prism

Microsoft Office

Job description

Job Title: Associate Formulation Scientist

Overview

The Associate Formulation Scientist supports the KaloCyte’s Research & Development team primarily with formulation of and analytical assays involved in the development and release testing of ErythroMer(EM), a bio-synthetic nano-formulated lyophilized artificial red blood cell. This role will fabricate and then assess the stability and particle characteristics of EM over time of 1) “wet” EM prior to lyophilization, and 2) lyophilized EM.

The Associate Formulation Scientist will also be involved with the analytical and bioanalytical methods transfer to the scale-up partner CDMOs for EM and its constituents. This role will additionally be tasked with all aspects for formulation of EM while developing skills necessary for QbD activities.Additional areas of support include running product purification processes, preparing and performing a variety of specialized and routine analytical tests and assays, calibrating, and maintaining instruments, data analysis and documentation, and other technical laboratory activities.

Critical Skills and Key Performance Indicators

• Fabrication of EM: Perform all fabrications steps of ErythroMer including hemoglobin filtration, hydration of lyocakes and extrusion of crude EM.
• Characterization of EM: Assess EM stability and particle characteristics pre- and post-lyophilization and optimizing the assay methods, separating biomolecules and small molecules based on differential chemical properties, performing qualitative and quantitative analyses involving statistical methods and setting error limits, creating new assays customized for KaloCyte needs, validating and verifying results through calibration and standardization; sampling, defining, isolating, concentrating, preserving samples, and maintaining a sample inventory.
• Post-fabrication Filtration: Perform resin cleaning process on small scale EM batches Identify and implement process and efficiency improvements.
• Lyophilization: Prepare solutions of lipids used to make lyocakes, lyophilize and evaluate stability of lipid cakes.Assist in the preparation and lyophilization of samples of EM.Assist in reconstitution and analysis of lyophilized materials
• R&D support: Assist with research studies, experiments and assays including experimental conduct, collection of data, preparation of solutions and equipment set-up. Troubleshoot issues with technical procedures; evaluate new types of experimental approaches analyses and recommend changes to protocols. Customize protocols to the biological systems utilized in the laboratory.
• Data management and reporting : Collect and enter research data into laboratory notebooks and databases. Prepare for analysis and interpretation. Report data and compile information into graphs and documents, keep logs and lab notebooks current, and maintain data files on research.
• Technical writing : Author, review, update, and maintain SOPS, protocols, and BPRs with current processes, and obtain necessary approvals/signatures.
• Communications: Participate in discussions of research protocols and objectives. Communicate results and conclusions to other scientists in a multi-disciplinary environment. Convey and discuss research results with team lab members and university collaborators.

Qualifications

• Master’s degree in Pharmaceutical Sciences or analytical chemistry or related field with minimum 1-year industrial experience in a drug development environment

OR

• Bachelor’s degree in chemistry or related field with minimum 2 years industrial experience in a drug development environment
• Ability to collaborate with Product Development team, Affiliate/University team and company’s Co-Founders.

Although not required, experience working in a glove box under inert atmosphere a plus.

Job Location / Working Conditions

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

Computer Skills

Strong proficiency with common laboratory and office productivity systems including GraphPad Prism, Adobe products, Microsoft Office (Word, Excel, PowerPoint, Project, Outlook), and video conferencing.

$55,000 – $65,000 per year

We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and benefits package including medical, dental and vision insurance, 401k with matching, 20 days of paid time off plus 6 sick days and 13 holidays.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

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