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Position: Quality Assurance Manager/Director
Location: New Brunswick, NJ
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
Conduct In-house CGMP training
Assist Regulatory Affairs Department with FDA inspections and
submissions
Coordinate and recommend improvement initiatives and quality
policy
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:
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Bachelors or higher degree in a scientific
discipline.
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Minimum of 5 to 7 years of quality assurance
background in the pharmaceutical industry (knowledge of sterile
manufacturing preferred).
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Minimum of 2 years of auditing experience.
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Working knowledge of FDA regulations, guidelines and
industry standards.
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Strong written and verbal communication, analytical,
audit and leadership skills.
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Ability to work well independently and as part of a
team.
Position: Manufacturing Technician
Location: New Brunswick, NJ
Job Description and Responsibilities:
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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.
Position: Clinical Research Associate
Location: Philadelphia, PA
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
- nteract with investigators and site staff
- Assure trial and investigator site compliance
with federal regulations, protocol requirements, ICH/GCP practices
and investigator integrity
- I
dentify 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
- 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
Requirements:
RN or BS degree
Minimum 2 years experience as a CRA
Position: Vice President of Quality Control
Location: New Brunswick, NJ
Job Description:
· Oversee
all QC operations for parenteral products in varying stages of
development (preclinical to commercial)
· Responsible
for overseeing QC testing for all manufacturing raw and in-process
materials, product lot release, clinical supplies and stability
program. The QC testing includes tests in chemistry, biochemistry,
protein chemistry, immunochemistry, microbiology, cell based bioassay,
and cell culturing.
· Troubleshoot
problems in QC testing, improve the test methods, validate the methods,
and if necessary development new assay methods.
·
Ensure that
all testing follows the company’s SOPs, standard test methods, and
current Good Laboratory Practices.
· The
QC Department is also responsible for environmental monitoring and water
sampling, and participates in manufacturing process validation and
improvement.
· Qualifying
vendors for biological source materials that include blood cells, serum,
virus, enzymes, antibodies, etc.
·
Actively
interact with Manufacturing, Regulatory, Quality Assurance and Clinical
Departments and oversee 2 QC Departments – Chemistry and Biologics.
Requirements:
· PhD
degree in biological science discipline.
· Minimum
of 7-10 years of QC and R&D experience in the biopharmaceutical or
pharmaceutical industry.
· Strong
scientific background in protein, polynucleotide or large molecule drug
development.
· Hands-on
experience with state of the art instruments in the areas of analytical
chemistry, biochemistry, protein chemistry, immunochemistry, cell
biology and microbiology.
· Knowledge
of manufacturing and testing of sterile drugs and FDA regulations,
guidelines and industry standards.
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: (215)
988-1739
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Via E-mail:
hr@hemispherx.net.
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