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- #109 Research Survey Group Director
- #110 Senior Research Survey Director
- #111 Bioinformatics Leader
- #112 Senior Scientist
- #113 Senior Scientist - Chemist
- #114 Director
Regulatory Affairs
- #115 Director QA & QC
- #116 Regulatory Scientist
- #117 Senior Associate
Regulatory Affairs
- #118 Manager - Calibration & Qualification
- #119 Facilities Engineer Manager
- #120 Director of Engineering
Operations
- #121 Senior Engineer for Quality Assurance
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#109
Research Survey Group Director
Establishes group’s goals and objectives
(strategic planning) and implements actions necessary to attain these
goals. Establishes marketing goals, implementing strategies, guidelines
and procedures for allocation of Group’s resources and facilities, and
recommends modifications to company’s policies. Must be familiar with
advanced scientific principles, theories, and concepts in developing
original research programs. Individual
should be recognized as a national authority in the survey research field.
Survey directors and varied staff specialists (epidemiologists,
psychologists, telephone survey staff, survey methodologists, etc) and a
national field staff report to this individual. Position requires
Master’s or Ph.D. degree and extensive related experience.
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#110
Senior Research Survey Director
Advanced degree and 10+
years of proven experience involving Epidemiology or Demography
/Survey positions to assist in strategic planning, program
development, developing proposals, directing projects and staff while
performing individual research in a corporate setting.
Must have authored articles published in peer-reviewed scientific
journals and have substantive technical and program management expertise
in social sciences and/or natural sciences.
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#111
Bioinformatics Leader
Degreed in basic sciences
or mathematics and document experience or supplemental information ability
to oversee program of proteomics, bioinformatics, data analysis and
computational biology application and design and development.
Individual must demonstrate ability to oversee implementation of
information technology and info systems for dissemination of biological
and research information as well as experimental data.
Must be experienced in developing and leading teams for
bioinformatics.
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#112
Senior Scientist
Ph.D. in a technical discipline and at least one year of work experience
in pharmaceutical dosage form formulation, or BS degree in Pharmacy or
Chemistry with at least five years of work experience in pharmaceutical
dosage form formulation. Involvement in all aspects of dosage form.
Trains and overseas the work of junior scientists and technicians.
Evaluates and recommends purchases of equipment and minerals.
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#113
Senior Scientist - Chemist
Ph.D.
in chemistry or related science from an accredited college or university
in addition to three or more years related experience in the
pharmaceutical industry. Develops
and validates new assay methods and solves technical problems in the
laboratory. Essential functions and responsibilities may include, but are
not limited to, the following: Develop and validate new assay methods
(i.e. placebo interference, forced degradation, linearity accuracy and
precision). Initiate and revise standard testing procedures for stability
indication analytical testing methods. Supervise less senior chemists in
their routine analytical work and provide training in advanced analytical
techniques.
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#114
Director Regulatory Affairs
Ability to set priorities
with available time frame. Experience
with Phase 2-3-4 trials, strategic planner, extensive experience
with FDA/PMA submissions.
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#115
Director QA & QC
Must be able to assure
conformance of specs of raw materials and in-process materials. Exercises
validation and document control. Must
have ability to interface effectively with FDA.
Involved with submissions IDE-50l(k) and PMA’s.
Supports clinical trials.
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#116
Regulatory Scientist
BS/MS * Pharmaceutical
& Medical Devices * IN/NDA submission experience * thorough
understanding of regulatory.
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#117
Senior Associate Regulatory Affairs
BS/MS Pharmaceutical or
medical device background INA/NDA?ANDA’S submission experience in a
variety of medical areas oncology, hematology, cardiology, etc.
In-vitro experience desired. Clinical
and pre-clinical research.
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#118
Manager - Calibration & Qualification
Reviews
and approves all IQ/OQ and performance qualification protocols and
reports. Evaluates all facility, utility systems, and solid oral dosage
manufacturing and packaging equipment (i.e. Water, HVAC. etc.) for IQ/OQ/PQ
and compliance with all regulatory requirements. Responsible for the
establishment and maintenance of metrology laboratory, and appropriate
standards equipment. Provides
technical services support throughout installation and qualification of
equipment and process, validation and production cycle. Applies total
quality management tools and approaches to analyze and report data to all
internal customers. Manages subordinate employees engaged in qualification
and calibration programs. Bachelor’s degree or equivalent from an
accredited college or university, in addition to five or more years of
progressively responsible qualification and validation experience,
preferably in the pharmaceutical industry, in a supervisory or management
capacity. cGMP, FDA and other pertinent regulatory requirements.
Pharmaceutical principles and practices and their application.
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#119
Facilities Engineer Manager
BS
in Engineering is preferred. A
minimum of 10 years of applicable engineering experience, with 5 years in
a management role. Experience
in computer based maintenance management systems as well as ability in CAD
drawing is desired. Strong knowledge of manufacturing production
equipment, site facility operations, including: engineering, utilities
(HVAC, plumbing, electrical), metrology systems, preventive maintenance,
repairs, spare parts inventory and safety within the department, in an FDA
regulated, cGMP environment. Prior experience with pharmaceutical utility
systems is a plus.
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#120
Director of Engineering Operations
A
Bachelor’s degree in an Engineering discipline; a Master’s degree
preferred, plus a minimum of 15 years experience, including leadership of
a plant engineering and maintenance organization as well as assignments
leading a project engineering group serving a multi-plant business.
Minimum of 10 years experience within the pharmaceutical industry.
Under the direction of the Vice President of Operations, the
Director, Engineering is responsible for the effective direction of all
Engineering activities in support of solid dosage products. Activities
include capital planning, project development and implementation,
facilities maintenance and improvement, all environment regulatory
matters, safety administration and housekeeping.
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#121
Senior Engineer for Quality Assurance
Bachelor’s
degree in engineering, or equivalent, from an accredited college or
university in addition to five or more years of progressively responsible
process engineering experience, preferably in pharmaceutical, food, or
cosmetic manufacturing environment. Assists
with problem solving, efficiency studies and the identification of process
improvement opportunities. Provides assistance in troubleshooting to
manufacturing and packaging areas. Interfaces with Quality Assurance and
R&D on process requirements for new and current products.
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