Quality Control Chemist

9/8/2021

Overview

KaloCyte is seeking a Quality Control Chemist with a strong background in bioanalytical chemistry.  The individual will primarily be tasked with the separation, purification, detection, identification, and quantification of biomolecules, and with the analytical assays involved in the development and release testing of ErythroMer™, a bio-synthetic nano-formulated lyophilized artificial red blood cell. This role will also be involved with the analytical and bioanalytical methods transfer to the scale-up partner CDMOs for ErythroMer™ and its constituents.

Responsibilities

  • 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
  • Interpreting data in proper context, preparing reports and charts for presentations and publications
  • Validating and verifying results through calibration and standardization
  • Sampling, defining, isolating, concentrating, preserving samples, and maintaining a sample inventory
  • Authoring, reviewing, updating, and maintaining SOPS, protocols, and BPRs with current processes, and obtaining necessary approvals/signatures
  • Communicating results and conclusions to other scientists in a multi-disciplinary environment
  • Assisting as required for achieving KaloCyte’s product development goals

Critical Skills/Expertise

  • Chromatography: Extensive experience with preparative (FPLC) and analytical (HPLC) method development, troubleshooting, and routine runs and analyses
  • Filtration & Purification Techniques: centrifugal filtration, dialysis, tangential flow filtration (TFF)
  • Gel electrophoresis (Native, reducing, and non-reducing), western blotting, protein determination techniques
  • UV-Vis and Fluorescence spectroscopy
  • NMR, Mass Spectrometry
  • pH meter, microbalance
  • Titration (KF)
  • Skilled at accurate pipetting for analytical chemistry standards
  • The preferred candidate would have experience in:
  • working with blood or blood products
  • nanoparticle fabrication in a drug development environment
  • nanoparticle analytical characterization techniques, NTA, DLS
  • regulatory process and documentation for CDER/CBER

Qualifications

  • Master’s degree in analytical chemistry or related field with minimum 3 years industrial experience in a drug/biologic’s development environment
  • OR
  • Bachelor’s degree in analytical chemistry or related field with minimum 5 years industrial experience in a drug/biologic’s development environment
  • Ability to collaborate with Product Development team, Affiliate/University team and company’s Co-Founders.

 

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 office productivity systems including Adobe products, Microsoft Office (Word, Excel, PowerPoint, Outlook), and video conferencing (GoToMeeting, Zoom, etc.). Experience with Prism® or another statistical software/s is a plus.


Salary

50,000.00 - $65,000.00 per year


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, 22 days of paid time off plus 6 sick days and 11 holidays.

Job Type : Full-Time
Education Level : Masters, Bachelors Degree
Experience Level : Mid to Senior Level
Job Function : General
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