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Position:        Manufacturing Supervisor
Location:       New Brunswick, NJ

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Job Description:

Biopharmaceutical Co. (New Brunswick, NJ) seeks Manufacturing Supervisor to supervise manufacturing of Polymers such as nucleic acid synthesis, extraction, & purification and freeze drying, equipment preparation and sterilization and manufacturing of blood derived alpha interferon & a synthetic RNA species.  Manage upstream operation of the interferon, incl. cell isolation and culture, cell harvesting, cell collection and bulk liquid concentration.  Supervise downstream operations in the interferon, incl. concentration and chromatography. Utilize knowledge of GMP, GLP, USP guidelines; be able to handle FDA inspection. Create, revise Manufacturing Standard Operating Procedures Batch Records. Review Batch records, Qualification protocols and relative documents.  

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Position:        Manufacturing Team Lead 
Location:       New Brunswick, NJ

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Job Description:

Biopharmaceutical Co. (New Brunswick, NJ) seeks Manufacturing Team Lead to supervise manufacturing technicians, perform reviews of batch records and rel. documentation, perform unit operations in the manufacturing of blood derived alpha interferon & a synthetic RNA species.  Manage upstream operation of the interferon, incl. cell isolation and culture, cell harvesting, cell collection and bulk liquid concentration.  Perform downstream operations in the interferon, incl. concentration and chromatography.  Ensure compliance with GMP, FDA and the International Conference of Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

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Position:        QC Biochemist 
Location:       New Brunswick, NJ

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Job Description:

Biopharmaceutical Co. (New Brunswick, NJ) seeks QC Biochemist to perform Polyacrylamide Gel Electrophoresis using staining methods such as Western Blot Analysis and Coomassie staining.  Perform dialysis of the samples using centrifugal filtration, perform qualification for biological components, qualification of Monoclonal and Polyclonal Antibodies, perform measurement of carbonylated proteins by ELISA and Densitometry Analysis on Shimanzu-Duel Wavelength TLC Scanner CS-930.  Prepare and review data repots.

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Position:        QA Manager 
Location:       New Brunswick, NJ

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Job Description:

Highly motivated individual to oversee all QA operations for parenteral products in varying stages of development (preclinical to commercial). The successful candidate will ensure that all QA functions are compliant with CGMP, GCP and GLP regulations and consistent with company procedures in addition to conducting internal and external audits thus providing continuous control over materials, facilities and products throughout the manufacturing cycle. 

Essential Duties and Responsibilities include:

  • Approve Change Controls and Deviation Reports, recommend corrective action as required;

  • Issue batch records, review and release of all batches;

  • Maintain document Archive area for all HEB master documents;

  • Develop and Maintain Raw Material process and Area, from receipt to dispensing;

  • Conduct In-house CGMP training;

  • Conduct companywide Safety Training;

  • Maintain and Manage Training System for all of HEB processes and procedures;

  • Assist Regulatory Affairs Department with FDA inspections and submissions;

  • Coordinate and recommend improvement initiatives and quality policy;

  • Oversee the Shipping and Receiving Department;

  • Review/Approve and process Work Order process;

  • Maintain Site-wide Calibration database and reports;

  • Maintain inventory database;

  • Oversee development of company Master Validation Plan;

  • Review and approve Validation Protocols and Reports;

  • Prepare Annual Product Reviews;

  • Approve company SOPs, Master Batch Records, Stability Protocols and Reports, Test Methods and Specifications;

  • Conduct audits for internal operations, contract manufacturers, testing labs, and suppliers;

  • Assist with preparation of CTD;

  • Oversee clinical supplies labeling, shipping and documentation

 Requirements:

  • Bachelors or higher degree in a scientific discipline.
  • Minimum of 5 to 7 years of quality assurance background in the pharmaceutical industry (knowledge of sterile manufacturing preferred).
  • Minimum of 2 years of auditing experience. 
  • Working knowledge of FDA regulations, guidelines and industry standards.
    Strong written and verbal communication, analytical, audit and leadership skills.  Ability to work well independently and as part of a team.

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Position:                    Clinical Research Associate

Location:                    New Brunswick, NJ
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Essential Duties and Responsibilities:

  •  Accountable for investigator site activities including, but not limited to, site selection, initiation, management and timelines, study drug delivery and management, specimen collection, and close-out activities;

  • Train investigator site personnel;

  • Monitoring / co-monitoring as required;

  • Interact with investigators and site staff;

  • Assure trial and investigator site compliance with federal regulations, protocol requirements, ICH/GCP practices and investigator integrity;

  • Identify areas requiring follow-up and improvement at investigator sites;

  • Retrieve and review regulatory documentation;

  • Manage SAE reporting procedures;

  • Maintain orderly and accurate files on clinical investigators and sites;

  • Responsible for managing investigator site and vendor budget activities;

  • Manage study drug supplies;

  • Track investigator payments;

 
  • Define, negotiate, and ensure execution of study-related agreements such as clinical trial agreements, CROs, laboratory services, etc.;

  • Provide periodic internal reports, as requested, regarding study activities;

  • Assist in the development of protocols, informed consents, case report forms, source notes and clinical reports;

  • Assist with the development and resolution of data queries;

  • Review of clinical trial data;

  • Organize and assist with investigator meetings;

  • Contribute to projects that support wider organization goals.

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Position:                    High Pressure Boiler Operator / General Maintenance
Location:                   New Brunswick, NJ
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The object of this position is to work with our facility and Lab personnel to help the company and its personnel reach their goals and provide a safe and efficient environment.  Workers will also follow CGMP requirements and company policies

High Pressure Boiler Operator

  • Operates high and low pressure boilers as schedule demands;

  • Monitor boiler water, chemicals, and fuel levels, and make adjustments to maintain required levels;

  • Observe and interpret readings on gauges, meters, and charts registering various aspects of boiler operation to ensure that boilers are operating properly;

  • Test boiler water quality or arrange for testing and take necessary corrective action, such as adding chemicals to prevent corrosion and harmful deposit;

  • Activate valves to maintain required amounts of water in boilers, to adjust supplies of combustion air, and to control the flow of fuel into burners;

  • Analyze problems and take appropriate action to ensure continuous and reliable operation  of equipment and systems;

  • Maintain daily logs of operation, maintenance, and safety activities, including test results, instrument readings and details of equipment malfunctions and maintenance work;

  • Switch from automatic to manual controls and isolate equipment mechanically and electrically to allow for safe inspection and repair (LOCK OUT TAG OUT);

  • Schedules and coordinates required boiler inspections.

General Maintenance

  • Inspect and diagnose problems and figure out the best way to correct them;
  • Checking Repair manuals, blue prints and diagrams;
  • Perform routine preventive maintenance to ensure that machines continue to run smoothly and document all maintenance;
  • Troubleshoot and repair electrical switches, outlets, and lights;
  • Maintains appropriate inventory of maintenance parts, supplies and tools by order supplies from catalogs;
  • Keep detailed records for work performed;
  • Basic computer skills;
  • Complete work orders submitted by QC / MFG;
  • Organizes and supervises outside contractors when necessary;
  • Replace belts and filters on HVAC equipment and trouble shoot air conditioning;
  • Paint walls, doors, windows, floors, woodwork, and repair drywall as needed.

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Position:                    Biochemist II
Location:                   New Brunswick, NJ
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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/MS 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.

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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.

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Position:       Manufacturing Associate
Location:      New Brunswick, NJ

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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/MS 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

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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.