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Position:       Manufacturing Associate
Location:      New Brunswick, NJ
______________________________________________________________________

Job Description:

  • Perform unit operations in the manufacture of blood derived alpha interferon and a synthetic RNA species. 
  • Operations in the manufacture of the interferon include but are not limited to cell isolation and culture, solution formulation, sterile component preparation, cell harvesting, bulk liquid concentration, preparative chromatography and related operations. 
  • Operations in the manufacture of the RNA include but are not limited to RNA synthesis, extraction, precipitation, diafiltration and freeze-drying. 
  • Both processes require compliance to cGMPs.

Job Requirements:

  • A minimum of 2 years experience in a cGMP manufacturing environment or a BS in life science, chemistry, or related field is required. 
  • Experience in at least some of the operations listed above would be preferable.
  • Experience with bio-hazardous materials and/or hazardous solvents is important.
  • Must be willing to work in a team environment.

 Please submit salary requirements with resume.

Position:        Director of Manufacturing
Location:       New Brunswick, NJ
___________________________________________________________________________

Job Description:

  • Responsible for management of Manufacturing Department, including production, logistics, and facility management.
  • Coordinates activities of contract manufacturer and contract distributor.
  • Supervises validation and calibration activities, and equipment purchase and maintenance.
  • Coordinates with Quality Departments to ensure cGMP compliance.
  • Reviews and approves documentation pertinent to manufacturing operations.
  • Implementation of aseptic processing standards.
  • Preparation of budget proposals and justification.
  • Interaction with domestic and foreign regulatory inspectors including Team Biologics.
  • Coordination with Regulatory/Quality Departments for drafting and submission of documents to various government agencies, both domestic and international.

Requirements:

  • BS/MS in scientific/engineering discipline with 10+ years experience in biopharmaceutical or pharmaceutical industry.
  • Experience with cell culture, protein purification, and polynucleotides.
  • Demonstrated understanding of cGMP regulations and guidelines governing the entire drug development process and manufacturing of parenteral products.
  • Experience in manufacturing process validation and improvement.
  • Demonstrated leadership skills and managerial capabilities.
  • Familiar with QA/QC and manufacturing documentation system.

 Please submit salary requirements with resume.

Position:        Microbiologist I

Location:       New Brunswick, NJ

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Job Responsibilities: 

  • Perform cell based bioassays such as Cytopathic Effect Inhibition assay for product lot release and stability testing. 

  • Prepare media and solutions, and maintain cell lines. 

  • Perform biochemical assays such as gel electrophoresis, protein and ELISA assays. 

  • Participate in environmental monitoring for manufacturing facilities that includes sampling, testing, and data analysis. 

  • Perform bacterial endotoxin LAL assay, bioburden assay and sterility testing for Alferon and Ampligen products.

  • Interact with manufacturing, QC and QA to coordinate the sampling schedules.

  • Independently complete required daily activities in the QC labs in compliance with company’s SOPs as well as appropriate health authority regulations and guidance. 

  • Review documents and prepare data reports.

Job Requirements/Education: 

  • BS in biochemistry or microbiology with 0 to 2 years of pharmaceutical industry experience. 

  • Hands-on experience in biochemical and/or microbiological testing is required.

  • Knowledge of tissue culture and bioassays is essential. 

  • Strong oral and written communication skills and ability to work in teams and multitask are needed.  

  • Familiarity with GMP, GLP, and FDA regulations is preferred. 

Please include salary requirements with resume.

Position:         QC Chemist II
Location:        New Brunswick, NJ
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Job Responsibilities:

  • Responsible for development and improvement of analytical methods used in product lot release, raw material release and stability studies.
  • The analytical methods include HPLC, UV/Visible spectroscopy, circular dichroism, gel permeation chromatography, ultracentrifugation, gas chromatography, and wet chemistry.  
  • The candidate is also responsible for validation of analytical methods, preparation of validation protocol and final reports, and for transfer of developed methods to QC staff. 
  • The main products for this position are a protein (Alferon N®) and a double stranded RNA, Ampligen®, and its single stranded RNA polymer intermediates. The analytical methods are used for identification and characterization of proteins, RNA products and impurities. 
  • The candidate is required to follow company’s SOPs as well as appropriate health authority regulations and guidance. 

Job Requirements/Education: 

  • BS/MS in chemistry with at least 2 to 4 years of analytical method development and validation experience in pharmaceutical industry.
  • Had worked with various analytical instruments such as HPLC, UV/Visible spectroscopy, gas chromatography, circular dichroism, ultracentrifuge, etc.
  • Strong oral and written communication skills and ability to work in teams and multitasks environment
  • Familiar with GMP, GLP, and FDA regulations. 
  • Familiarity with proteins a plus.

Please include salary requirements with resume.

Position:        Biochemist II
Location:        New Brunswick, NJ ____________________________________________________________________________

 Responsibilities: 

  • Perform cell based bioassays such as Cytopathic Effect Inhibition assay for product lot release and stability testing.
  • Prepare media and solutions, and maintain cell lines.  Evaluate human leukocytes and perform qualification for biological components used in manufacturing of interferon product.
  • Perform biochemical assays such as gel electrophoresis, protein and ELISA assays.
  • Participate in environmental monitoring for manufacturing facilities that includes sampling, testing, and data analysis.
  • Interact with manufacturing, QC and QA to coordinate the sampling schedules.
  • Independently complete required daily activities in the QC labs in compliance with company’s SOPs as well as appropriate health authority regulations and guidance.  Review documents and prepare data reports.

Requirements/Education: 

  • BS with a minimum of 5 years of pharmaceutical industry experience or MS degree with a minimum of 2 years experience. 
  • Hands-on experience in biochemical testing and tissue culture is required. 
  • Knowledge of protein chemistry, DNA, and RNA is a plus.
  • Strong oral and written communication skills and ability to work in teams and multitask are needed.  
  • Familiarity with GMP, GLP, and FDA regulations is preferred. 

 Please include salary requirements with resume.

Position:       Clinical Programmer/Biostatistician
                     (Contract Work for College Students)
Location:      Philadelphia, PA
 _________________________________________________________________

Responsibilities

  • Analysis of clinical data.
  • Write summaries of statistical results.
  • Create templates for tables, listings and graphs.

Experience 

  • Experience or training performing statistical analyses of clinical trial data a plus.
  • Must be comfortable with writing SAS code and directing others on writing SAS code.
  • Operating Systems – PC/SAS, Word.

Work schedule and hours are flexible. 

Hourly rate is negotiable.

 

Position:       Clinical Programmer/Biostatistician
Location:      Philadelphia, PA
  _______________________________________________________________

Responsibilities

  • Advise on, draft, and conduct statistical analysis plans for Phase II, Phase III, and pre-clinical animal studies and conduct the analysis plans.
  • Write statistical text for study concept documents and protocols (study design, endpoints, sample size, methods for analysis).
  • Create templates for tables, listings and graphs.
  • Oversee external partners and vendors.
  • Review protocols, clinical report forms, clinical study reports, and other study documents.
  • Help respond to the FDA on their queries to a recent NDA submission.

Required Experience 

  • MS with 3 years experience or PhD with 1 year experience with clinical trials.
  • Must be comfortable with writing SAS code and directing others on writing SAS code.
  • Operating Systems – PC/SAS, Word.

 Preferred Experience 

  • MS with 5 years experience or PhD with 2 years of experience with clinical trials.

 

 

Position:     Laboratory Assistant

Location:    New Brunswick, NJ 

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Job Responsibilities:

       ASSISTING WITH SOLUTION AND MEDIA PREPARATION

  • Daily preparation of solutions used in the microbiology laboratory
  • Keep GMP documentation of all activities at time of performance
  • Follow written Standard Operating Procedures (SOPs) for daily activities

       QC LABS/ PDI- OVERALL MAINTENANCE

  • Remove garbage as necessary
  • Clean labs as per appropriate SOP
  • Remove bins of dirty glassware from the labs
  • Perform cleaning of the QC Freezers and Refrigerators, clean filters/fins and or coils when due
  • Maintain inventory of glassware and supplies                      
  • Prepare and maintain cleaning solutions for the lab as needed
  • Distribute all QC glassware, etc to their appropriate areas
  • Performing use and maintenance of the QC autoclave, glassware washer and dryer  
  • Daily, weekly and monthly upkeep and documentation

 Job Requirements:

  • Minimum of a High School Diploma or equivalent, previous experience in a similar position preferred. 

  • Basic knowledge of chemicals and safety 

  • Ability to comprehend and apply SOPs and company policies with attention to  detail.  

  • Ability to work in a fast-paced environment, perform repetitive tasks, with manual dexterity

  • Strong organizational skills 

  • Task oriented 

  • Good interpersonal skills   

  • Able to lift 50 lbs.  

  • Standing for extended periods

Please forward resumes:

  • Via US Mail:
    Hemispherx Biopharma, Inc.
    Director of Human Resources   
    783 Jersey Avenue
    New Brunswick, NJ  08901

  • Via Facsimile: (732) 249-6895

  • Via E-mail: hr@hemispherx.net.
 
 

 
Information contained on the Hemispherx website other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risks of competition, changing market conditions, changes in laws and regulations affecting these industries and numerous other factors discussed on the Hemispherx website and in the Company's filings with the Securities and Exchange Commission. Accordingly, actual results may differ materially from those in any forward-looking statements. Additionally, all the referenced investigational drugs and associated technologies of the company are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgement as of the date of this website. The Company disclaims, however, any intent or obligation to update these forward-looking statements.