(Sr.) Manager, Analytical Development
About Matinas BioPharma
Matinas BioPharma is a clinical-stage biopharmaceutical company focused on developing next generation therapeutics to advance standards of care for patients in areas of significant unmet medical need. Company leadership has a deep history and knowledge of drug development and is supported by a world-class team of scientific advisors.
In particular, Matinas is developing a portfolio of products based upon its proprietary lipid nanocrystal (LNC) drug delivery platform, which can solve complex challenges relating to the safe and effective delivery of potent medicines, making them orally bioavailable, less toxic and targeted to cells and tissues.
About the position:
This is a primarily hands-on lab position to provide critical analytical feedback to our lipid nanocrystal formulation team. The main responsibility is to support key analytical method development and characterization activities within the Discovery group. In this role, you will be responsible for developing fit-for-use analytical methods that will be used to assess and screen lipid nanocrystal formulations and stability. Major activity involves HPLC method development to characterize drug encapsulation efficiency by separating and quantifying drugs that are distributed in aqueous phase, free crystal forms, and encapsulated in lipid nanocrystal. Other responsibility includes identification and quantification of lipid excipient and drug product stability studies. In addition to chromatography-based methods for the qualification/quantitation of lipids, proteins, nucleic acids, and drug, other techniques for nanoparticle biophysical characterization, such as particle size analysis, zeta potential, microscopy, etc., will be utilized as well.
Based upon the versatility of our LNC technology platform, a wide range of drug substances will be investigated: small molecules, proteins/peptides, monoclonal antibodies, mRNA, DNA, oligonucleotides, etc. Bioanalytical experience on quantification, stability evaluation, intracellular trafficking, and in vitro potency of such modalities will be a major plus.
While you will be mostly developing non-GMP research fit-for-use analytical methods, you will serve as a liaison to transfer the method from discovery to GMP development team once method development completed. GMP analytical experiences on method verification and validation are a major plus.
- Work very closely with formulation team to provide timely analytical feedback for lipid nanocrystal formulation development.
- Independently develop HPLC methods to characterize drug encapsulation efficiency and stability.
- Independently develop fit-for-use analytical methods to quantify lipids and assess lipid stability.
- Interact with external partners for tech transfer, evaluation, and optimization of their assays.
- Write and review assay protocols and prepare reports of experimental findings.
- Serve as an analytical liaison for method transferred out to GMP analytical team, or transferred in from external collaborators.
- Ph.D. in analytical chemistry or MS with an outstanding track record
- At least 3-5 years of HPLC method development and validation experiences in pharmaceutical industry
- Proficient with common analytical techniques and instrumentations: separation techniques (e.g., HPLC, GC, TLC), in-vitro dissolution, general/wet chemical methods, physical characterizations (e.g., particle size analysis, SEM and light microscopy), spectroscopy (e.g., UV/Vis and FTIR) and thermal methods (e.g., DSC, TGA).
- Strong knowledge of industry practices and regulatory guidance for a variety of analytical development, qualification/ validation.
- Extensive hands-on experience with the design, development, optimization, qualification and validation technologies.
Standing to perform bench tests, bending, lifting up to 40 lbs, and ability to wear all required safety equipment such as safety glasses, mask, gloves, lab coat as work and environment require.
To apply please email your resume to Careers@MatinasBioPharma.com
Back to Careers