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Position: Manufacturing Associate
Location: New Brunswick, NJ
______________________________________________________________________
Job Description:
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Perform unit operations in the manufacture of blood
derived alpha interferon and a synthetic RNA species.
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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.
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Operations in the manufacture of the RNA include but
are not limited to RNA synthesis, extraction, precipitation,
diafiltration and freeze-drying.
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Both processes require compliance to cGMPs.
Job Requirements:
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A minimum of 2 years experience in a cGMP
manufacturing environment or a BS in life science, chemistry, or
related field is required.
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Experience in at least some of the operations listed
above would be preferable.
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Experience with bio-hazardous materials and/or
hazardous solvents is important.
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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:
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Responsible for management of Manufacturing
Department, including production, logistics, and facility
management.
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Coordinates activities of contract manufacturer and
contract distributor.
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Supervises validation and calibration activities, and
equipment purchase and maintenance.
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Coordinates with Quality Departments to ensure cGMP
compliance.
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Reviews and approves documentation pertinent to
manufacturing operations.
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Implementation of aseptic processing standards.
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Preparation of budget proposals and justification.
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Interaction with domestic and foreign regulatory
inspectors including Team Biologics.
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Coordination with Regulatory/Quality Departments for
drafting and submission of documents to various government agencies,
both domestic and international.
Requirements:
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BS/MS in scientific/engineering discipline with 10+
years experience in biopharmaceutical or pharmaceutical industry.
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Experience with cell culture, protein purification,
and polynucleotides.
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Demonstrated understanding of cGMP regulations and
guidelines governing the entire drug development process and
manufacturing of parenteral products.
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Experience in manufacturing process validation and
improvement.
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Demonstrated leadership skills and managerial
capabilities.
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Familiar with QA/QC and manufacturing documentation
system.
Please
submit salary requirements with resume.
Position: Microbiologist I
Location: New Brunswick, NJ
________________________________________________________________
Job Responsibilities:
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Perform cell based
bioassays such as Cytopathic Effect Inhibition assay for product lot
release and stability testing.
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Prepare media and
solutions, and maintain cell lines.
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Perform biochemical
assays such as gel electrophoresis, protein and ELISA assays.
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Participate in
environmental monitoring for manufacturing facilities that includes
sampling, testing, and data analysis.
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Perform bacterial
endotoxin LAL assay, bioburden assay and sterility testing for
Alferon and Ampligen products.
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Interact with
manufacturing, QC and QA to coordinate the sampling schedules.
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Independently
complete required daily activities in the QC labs in compliance with
company’s SOPs as well as appropriate health authority regulations
and guidance.
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Review documents and
prepare data reports.
Job Requirements/Education:
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BS in biochemistry or microbiology with 0
to 2 years of pharmaceutical industry experience.
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Hands-on experience in biochemical and/or
microbiological testing is required.
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Knowledge of tissue culture and bioassays
is essential.
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Strong oral and written communication
skills and ability to work in teams and multitask are needed.
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Familiarity with GMP, GLP, and FDA
regulations is preferred.
Please include salary requirements with resume.
Position: QC Chemist II
Location: New Brunswick, NJ
___________________________________________________________________________
Job Responsibilities:
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Responsible for development and improvement of
analytical methods used in product lot release, raw material release
and stability studies.
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The analytical methods include HPLC, UV/Visible
spectroscopy, circular dichroism, gel permeation chromatography,
ultracentrifugation, gas chromatography, and wet chemistry.
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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.
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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.
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The candidate is required to follow company’s SOPs as
well as appropriate health authority regulations and guidance.
Job Requirements/Education:
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BS/MS in chemistry with at least 2 to 4 years of
analytical method development and validation experience in
pharmaceutical industry.
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Had worked with various analytical instruments such
as HPLC, UV/Visible spectroscopy, gas chromatography,
circular dichroism,
ultracentrifuge, etc.
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Strong oral and written communication skills and
ability to work in teams and multitasks environment
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Familiar with GMP, GLP, and FDA regulations.
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Familiarity with proteins a plus.
Please include salary requirements with resume.
Position: Biochemist II
Location: New Brunswick, NJ
____________________________________________________________________________
Responsibilities:
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Perform
cell based bioassays such as Cytopathic Effect Inhibition assay for
product lot release and stability testing.
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Prepare
media and solutions, and maintain cell lines. Evaluate human
leukocytes and perform qualification for biological components used
in manufacturing of interferon product.
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Perform
biochemical assays such as gel electrophoresis, protein and ELISA
assays.
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Participate in environmental monitoring for manufacturing facilities
that includes sampling, testing, and data analysis.
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Interact
with manufacturing, QC and QA to coordinate the sampling schedules.
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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:
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BS with a
minimum of 5 years of pharmaceutical industry experience or MS
degree with a minimum of 2 years experience.
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Hands-on
experience in biochemical testing and tissue culture is required.
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Knowledge
of protein chemistry, DNA, and RNA is a plus.
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Strong
oral and written communication skills and ability to work in teams
and multitask are needed.
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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
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Analysis of clinical data.
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Write summaries of statistical results.
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Create templates for tables, listings and graphs.
Experience
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Experience or training performing statistical
analyses of clinical trial data a plus.
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Must be comfortable with writing SAS code and
directing others on writing SAS code.
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Operating Systems – PC/SAS, Word.
Work schedule and hours are flexible.
Hourly rate is negotiable.
Position: Clinical Programmer/Biostatistician
Location: Philadelphia, PA
_______________________________________________________________
Responsibilities
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Advise on, draft, and conduct statistical analysis
plans for Phase II, Phase III, and pre-clinical animal studies and
conduct the analysis plans.
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Write statistical text for study concept documents
and protocols (study design, endpoints, sample size, methods for
analysis).
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Create templates for tables, listings and graphs.
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Oversee external partners and vendors.
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Review protocols, clinical report forms, clinical
study reports, and other study documents.
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Help respond to the FDA on their queries to a recent
NDA submission.
Required Experience
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MS with 3 years experience or PhD with 1 year
experience with clinical trials.
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Must be comfortable with writing SAS code and
directing others on writing SAS code.
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Operating Systems – PC/SAS, Word.
Preferred
Experience
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MS with 5 years experience or PhD with 2 years of
experience with clinical trials.
Position: Laboratory Assistant
Location: New
Brunswick, NJ
______________________________________________________________________
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:
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Minimum of a High
School Diploma or equivalent, previous experience in a similar
position preferred.
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Basic knowledge of
chemicals and safety
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Ability to comprehend
and apply SOPs and company policies with attention to detail.
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Ability to work in a fast-paced
environment, perform repetitive tasks, with manual dexterity
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Strong organizational
skills
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Task oriented
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Good interpersonal
skills
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Able to lift 50 lbs.
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Standing for extended
periods
Please forward resumes:
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Via US Mail: Hemispherx Biopharma, Inc.
Director of Human
Resources
783 Jersey Avenue
New Brunswick, NJ
08901
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Via Facsimile: (732)
249-6895
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Via E-mail:
hr@hemispherx.net.
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