Basic Function

The Scientist Level III is a seasoned AD chemist that performs development, optimization, transfer and validation of analytical methods for products and raw materials.  When required, the scientist supports testing of raw materials, in-process, finished product and stability samples in support of clinical studies, stability and product development. Tests include assay, chromatographic purity, content uniformity, particle size distribution, density, water determination by KF and TOC according to in-house methods and USP monographs.

Specific Job Responsibilities

• Performs development, optimization, transfer and validation of methods for products and raw materials.
• Troubleshoots methods to determine root causes of issues and verifies methods for release to the lab.
• Prepares analytical methods, protocols, reports and standard operating procedures, as required.
• Performs testing of raw materials, in-process, finished product and stability samples including HPLC assay, chromatographic purity, content uniformity, particle size distribution, density, water determination by KF and TOC according to in-house methods and USP monographs in support of clinical studies and biopharma drug product development.
• Maintains accurate lab notebooks, completes all related analytical reports, writes summaries and keeps proper documentation in compliance with SOP’s. Ensures notebooks are reviewed in a timely manner in accordance with SOP requirements.
• Assists in maintaining and calibrating laboratory equipment (e.g. HPLC, GC).
• Maintains the laboratory and work areas as per good housekeeping practices and in compliance with EHS.

Required Skills and Competencies

• Prior experience with the optimization and validation of analytical test methods.
• Working knowledge of laboratory instrumentation as referred to in job responsibilities and associated software where applicable. Extensive experience with Empower is required.
• Ability to work on multiple method (HPLC, GC, PSD) projects of a complex nature simultaneously.
• Experience investigating complex test failures and determining root causes.
• Ability to carry out and complete necessary computations and present / interpret data.
• Working knowledge of USP, ICH and FDA guidelines in a GMP regulated lab environment.
• Possesses and demonstrates a wide degree of creativity and problem-solving skills. 
• Excellent communications skills with demonstrated ability to communicate clearly in English in both written and spoken form.

Education and Experience

• BS degree in chemistry or related discipline. MS degree preferred.
• 5 plus years relevant experience with BS degree. 3 plus years with MS. Pharmaceutical lab experience required, with biopharma lab experience preferred.
• Able to perform laboratory function associated with position and required in a research lab.

Physical Qualifications

• 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

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.

Position Overview

This position is located in Bridgewater, NJ but we are conducting a nationwide search for qualified candidates.

The Chemistry Manufacturing and Control (CMC) Program Manager will provide project management support to our CMC team. In conjunction with internal subject matter experts and consultants, The Program Manager will be responsible for managing the planning (including timelines, costs, and resources) and on-time completion of product development activities from discovery hand-off through NDA submission and approval. The Project Manager will report to the Director, Program Management. The successful candidate must possess a strong technical understanding of the inter-disciplinary nature of drug development, demonstrated with previous drug development and/or manufacturing experience. The position will require timeline and deliverable management with close collaboration with CMC team members to ensure timely development, manufacturing, testing of drug substance and drug product, regulatory submissions, and supply of clinical trial material.

Specific Job Responsibilities

• Provide project management support for CMC and supply chain activities to support development, manufacturing, release and shipments of drug substance and drug product, analytical method development and transfer, stability, and supply chain related activities
• Facilitate planning of CMC activities across drug substance, drug product and clinical supply chain to align dependencies, schedules, and delivery commitments
• Create, manage, and facilitate regular meetings, including the development of agendas, issue written minutes, and follow up on action items
• Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team member(s)
• Develop project plans with minimal support from others and works closely with project leads and/or department head
• Supports CMC project lead/department head with the optimization of CMC project deliverables (schedules, resources, budgets)

Experience and Skills

• Required
  • S. degree in scientific field and > 5yrs of PM experience at biotech or pharmaceutical company with direct involvement in the CMC area
  • Experience working in cross functional teams
  • Experience with budget planning
  • Experience with IND submission process
  • Excellent interpersonal and organizational skills
  • Excellent written and verbal communication skills
  • Expert knowledge of MS Project and proficient in MS Office
  • Understanding of GMPs, GLPs and Biopharmaceutical Product Development
  • Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
  • Must have the ability to build and maintain positive relationships with management and peers
  • Ability to work on site
  • Ability to work in a matrix reporting structure
• Preferred
  • NDA management/coordination experience
  • Strong technical understanding of inter-disciplinary nature of drug development, contract manufacturing, analytical development, document control, technology transfer, and CMC regulatory filings
  • Experience in a GMP environment; both drug substance and drug product manufacturing in prescription drug setting

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. 

Responsibility: 

• 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. 

Qualifications: 

• 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. 

Physical Qualifications 

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

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:

The main responsibility for this role is to independently establish a cell culture lab, maintain a cell bank, develop and perform cell-based assays to provide critical feedback to guide LNC drug product development and formulation optimization. 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. Quantification, stability evaluation, intracellular trafficking, and in vitro potency of such modalities will be the essential element of the role. The relevant assays may include intracellular uptaking assessments, gene expression, gene knock-down, RNA stability, cytotoxicity, and/or in vitro biological potency. This position will report to the CTO but operate with considerable autonomy under minimal supervision; therefore, the incumbent is expected to be a self-starter with at least 3-5 years bioanalytical and assay development experience with a proven track record.

Responsibility:

• Establish a cell culture lab: acquire necessary instruments and materials to establish a cell culture lab and maintain a cell bank
• Develop and optimize cell-based assays to evaluate lipid nanocrystal formulations, and provide critical feedback to formulation team
• Interact with external partners for tech transfer, evaluation, and optimization of their assays
• Write and review assay protocols and prepare reports of experimental findings
• Report and document results in a timely fashion
• Participate in the tech transfer of formulations developed to the GMP manufacturing and analytical labs, as appropriate

Qualifications:

• Ph.D. in molecular biology, biochemistry, biomedical engineering, pharmaceutical science, or MS with an outstanding track record
• 3-5 years of cell-based assay development and validation experiences in biopharmaceutical industry
• 3-5 years of experience in establishing and operating a cell culture lab, and maintaining a cell bank
• Assay development expertise with mRNA, SiRNA, DNA, oligonucleotides, proteins, etc.
• Strong knowledge of industry practices and regulatory guidance for a variety of biological assay development, qualification/ validation
• Extensive hands-on experience with the design, development, optimization, qualification and validation technologies (e.g., ELISA, MSD, flow cytometry and cell based-proliferation, fluorescence, antibody characterizations, reporter and cytotoxicity assays)
• Proficiency in common software and data analysis packages (e.g., SoftMax Pro, GraphPad Prism, JMP, Microsoft Office tools).

Physical Qualifications

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

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: 

The main responsibility for this role is to independently establish a cell culture lab, maintain a cell bank, develop and perform cell-based assays to provide critical feedback to guide LNC drug product development and formulation optimization.  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.  Quantification, stability evaluation, intracellular trafficking, and in vitro potency of such modalities will be the essential element of the role. The relevant assays may include intracellular uptaking assessments, gene expression, gene knock-down, RNA stability, cytotoxicity, and/or in vitro biological potency.  This position will report to the CTO but operate with considerable autonomy under minimal supervision; therefore, the incumbent is expected to be a self-starter with at least 3-5 years bioanalytical and assay development experience with a proven track record.  

Responsibility: 

• Establish a cell culture lab: acquire necessary instruments and materials to establish a cell culture lab and maintain a cell bank 
• Develop and optimize cell-based assays to evaluate lipid nanocrystal formulations, and provide critical feedback to formulation team 
• Interact with external partners for tech transfer, evaluation, and optimization of their assays 
• Write and review assay protocols and prepare reports of experimental findings 
• Report and document results in a timely fashion 
• Participate in the tech transfer of formulations developed to the GMP manufacturing and analytical labs, as appropriate 

Qualifications: 

• Ph.D. in molecular biology, biochemistry, biomedical engineering, pharmaceutical science, or MS with an outstanding track record 
• 3-5 years of cell-based assay development and validation experiences in biopharmaceutical industry 
• 3-5 years of experience in establishing and operating a cell culture lab, and maintaining a cell bank 
• Assay development expertise with mRNA, SiRNA, DNA, oligonucleotides, proteins, etc. 
• Strong knowledge of industry practices and regulatory guidance for a variety of biological assay development, qualification/ validation  
• Extensive hands-on experience with the design, development, optimization, qualification and validation technologies (e.g., ELISA, MSD, flow cytometry and cell based-proliferation, fluorescence, antibody characterizations, reporter and cytotoxicity assays) 
• Proficiency in common software and data analysis packages (e.g., SoftMax Pro, GraphPad Prism, JMP, Microsoft Office tools). 

Physical Qualifications 

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 

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 hands-on lab position focusing on formulation, characterization, and process development of our proprietary LNC drug delivery system, which has proven applications to a variety of therapeutic areas and drug classes including infectious diseases, vaccines, mRNA, DNA, and/or oligonucleotide-based gene therapy, peptides/proteins, biologics, and small molecules. Formulation, process development, and optimization of these treatment modalities will be an essential element of the role. This position will report to CTO of the company.

Responsibilities:

• Develop and optimize LNC delivery systems with formulation composition, excipients, process conditions
• Understand the intricacy of LNC system, and propose new ideas/strategies to address deficiencies and optimize opportunities through innovative thinking
• Characterize fundamental nanoparticulated properties: particle size, encochleation efficiency, stability, drug release, etc.
• Drive internal and external projects to successful completion with high quality and precision in a timely fashion
• Support ongoing process optimization and scale-up for existing clinical programs and new projects
• Provide technical expertise to support tech transfer from Research to Development manufacturing and GMP analytical lab
• Writing/reviewing formulation and analytical protocols and reports

Qualifications:

• Ph.D. in chemistry, chemical engineering, biology, biochemistry, pharmaceutical science, or MS with an outstanding track record
• 3-5 years of pharmaceutical formulation development experiences with a successful track record in formulation development and problem-solving
• In-depth understanding and experience in lipid nanoparticle formulation, phospholipids, mRNA, SiRNA, proteins, etc.
• Proficient in analytical techniques and nanoparticle characterizations: particle size, HPLC, DSC, RiboGreen assay, etc.
• Experience in assay development, particularly cell-based assay, is a major plus
• Experience in lyophilization, spray-drying, and fill-finish is a plus

Physical Qualifications

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

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 hands-on lab position focusing on formulation, characterization, and process development of our proprietary LNC drug delivery system, which has proven applications to a variety of therapeutic areas and drug classes including infectious diseases, vaccines, mRNA, DNA, and/or oligonucleotide-based gene therapy, peptides/proteins, biologics, and small molecules.  Formulation, process development, and optimization of these treatment modalities will be an essential element of the role. This position will report to CTO of the company. 

Responsibilities: 

• Develop and optimize LNC delivery systems with formulation composition, excipients, process conditions 
• Understand the intricacy of LNC system, and propose new ideas/strategies to address deficiencies and optimize opportunities through innovative thinking 
• Characterize fundamental nanoparticulated properties: particle size, encochleation efficiency, stability, drug release, etc. 
• Drive internal and external projects to successful completion with high quality and precision in a timely fashion 
• Support ongoing process optimization and scale-up for existing clinical programs and new projects 
• Provide technical expertise to support tech transfer from Research to Development manufacturing and GMP analytical lab 
• Writing/reviewing formulation and analytical protocols and reports 

Qualifications: 

• Ph.D. in chemistry, chemical engineering, biology, biochemistry, pharmaceutical science, or MS with an outstanding track record 
• 3-5 years of pharmaceutical formulation development experiences with a successful track record in formulation development and problem-solving 
• In-depth understanding and experience in lipid nanoparticle formulation, phospholipids, mRNA, SiRNA, proteins, etc. 
• Proficient in analytical techniques and nanoparticle characterizations: particle size, HPLC, DSC, RiboGreen assay, etc. 
• Experience in assay development, particularly cell-based assay, is a major plus  
• Experience in lyophilization, spray-drying, and fill-finish is a plus 

Physical Qualifications 

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 

The Clinical Manufacturing Technician, LNC Manufacturing is responsible for the safe and compliant manufacture of clinical drug products as well as maintaining the manufacturing area in a clean, well supplied, and orderly state.

The Clinical Manufacturing Operator, LNC Manufacturing Will Be Specifically Responsible For

• Manufacturing of Clinical Supply Batches
• Packaging and Labeling of Clinical Supply Batches
• Following area Standard Operating Procedures
• Cleaning of the Clinical Manufacturing Facilities and Equipment.
• Management of Inventory to include Raw Materials, API, and Finished Goods. Responsible for receipt, sampling, and inventory tracking.
• Maintaining USP Purified Water system
• Cleaning and Use Log Entries
• Supporting the introduction of new products and technologies into the facility.
• Maintaining the clinical batch manufacturing area in compliance with Regulatory Agency requirements.
• Any other duties assigned.
  
  

Reports To

Manager, Clinical Manufacturing

Qualifications

High School diploma and 5-8 years of drug product manufacturing or operations experience OR

Associate degree and 3-5 years of drug product manufacturing or operations experience

To apply please email your resume to Careers@MatinasBioPharma.com