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Director
of Analytical Services
A pharmaceutical company located in Connecticut is
seeking a Director of Analytical Services whom develops
or coordinates the development of appropriate methodologies
to ensure full compliance to Regulatory Agency guidance
or requirements related to Dry Powder Inhalation dosage
forms. Interprets and evaluates the analyses in terms
of accuracy and precision and recommends corrective
action where necessary. Develops new or applies existing
techniques and procedures with recommendations and implementation
of modification for improved efficiency, or devises
and develops new analytical methods and techniques.
May also be involved in establishing requirements for
the transfer of methodology to Quality Control. May
require knowledge of one or more of the following automated
techniques: gas, liquid, thin layer or column chromatography,
ion exchange, infrared, ultraviolet and visible spectrophotometer,
nuclear magnetic resonance, differential scanning cotorimetry,
microscopy, and automated continuous analysis. Chairs
or co-chairs the Specification Committee and fully supports
CMC and FDA liaison activities.
Education and experience required:
Bachelor's Degree with 15+ years related experience
or an equivalent combination of training and experience
in a scientific discipline. Previous QA experience desirable.
At least 5 years in a supervisory role. Well-established
expert in the field of combination product (device,
formulation) requirements. Demonstrated knowledge of
GMP regulations and industry standard.
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Scientist
AR&D
Pharmaceutical company located in Northern NJ is seeking
a Scientist / Senior Scientist AR&D to perform routine
testing of process validation samples, raw materials,
finished products, stability samples, and developmental
samples in a regulated laboratory environment. Analyze
and interpret results in written and oral format.
Duties and Responsibilities:
Perform routine tests including dissolution, assays,
chromatographic purity, content uniformity using UV
and HPLC, particle size distribution using different
techniques including Light scattering (e.g., Malvern),
density, water determination by KF, and tests according
to the in-house monographs and USP.
Maintain accurate lab notebooks and complete all related
analytical reports, in compliance with SOPs.
Ensure notebooks are reviewed in a timely manner, in
accordance with SOPs.
Follow all SOPs and Safety Guidelines to ensure compliance
with a cGMP environment and Safety Practices.
Analyze and interpret results in written and oral format
in consultation with supervisor/project leaders.
Education/Experience Requirements:
Scientist and Senior Scientist are similar positions
with similar responsibilities. The determination of
level is based on the incumbent's education, experience
and ability to handle more complex testing, perform
peer notebook review, train and guide less experienced
scientists, and troubleshoot problems, all with less
supervision.
Bachelors to Master's degree in Chemistry or related
scientific field
2 to 6 years of related experience and/or training OR
equivalent combination of education and experience OR
PhD with 0-2 years industrial experience. Preference
of generic background. Strong analytical background,
strong understanding of product development. Knowledge
of Excel Spreadsheet software and MS Office Suite Word
Processing software. Ability to deal with problems involving
several concrete variables in standardized situations.
Ability to carry out necessary computations and to draw
and interpret graphs.
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Research
Scientist/Sr Research Scientist, Analytical Method Development
Pharmaceutical company located in New York seeks a Research
Scientist/Sr Research Scientist, Analytical Method Development.
Description of Duties and Responsibilities:
Developing and validate routine testing methods to the
R&D Analytical Pharmaceutical Laboratory
Ensure procedures conforms to appropriate standards
of identity, strength, quality and purity for components,
bulk and finished products, scale-up samples, process
validation samples, cleaning validation samples, marketed
stability samples, affiliate samples and international
manufacturing samples
Ensure training programs are properly developed and
implemented
Ensure that the Laboratory Analysts are technically
developed
Coordinate the laboratory equipment qualifications,
calibrations and preventative maintenance programs as
needed
Coordinate internal laboratory projects
Develop and implement systems and training to ensure
successful completion of these projects
Audit/Review all laboratory data for approval to next
step
Develop and implement local laboratory policies and
procedures" Audit the laboratory for compliance
to cGMPs and safety requirements
Develop procedures, systems, practices to ensure compliance
to all regulatory requirements
Recommend the need for new equipment to serve expanding
operational and regulatory requirements sufficiently
in advance of the need
Ensure specific objectives and goals of the department
are met
Candidate will work independently
Requirements:
PhD with 0-8 years in methods development in relevant
pharmaceutical development area. Must have strong chromatography
exp. Preference given to candidates with pharmaceutical
industry experience.
Strong HPLC, computer, written and oral communications
and troubleshooting skills are required. LC/MS experience
is desirable. GC, MS, IR, thermal techniques a plus.
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Technical
Writer, CMC
Pharmaceutical company located in New York seeks a
Technical Writer, CMC. Responsibilities will include:
" Demonstrate experience in the pharmaceutical
industry having either worked in related areas in pharmaceutical
R&D (analytical, formulation/preformulation, process/
chemical development, etc.), Quality Assurance or Regulatory
Affairs
" Familiarity with (FDA) regulatory guidelines
and cGMP/cGLP guidances are essential
" Prior experience in the preparation of patents,
technical publications, and regulatory dossiers including
DMF's, CMC sections of IND's/ NDA's and MAA's is highly
desirable
" Prior exp to CTD and/or electronic submission
is a plus
" Must demonstrate good oral and written communication
skills
" Should positively demonstrate ability to work
in a team environment. Preference will be given to candidates
with exp and working knowledge in pharmaceutical development
program and project team leadership skills
Candidate must have experience with Documentum (electronic
submissions)
A BS/MS with 2-10 years exp or Ph.D. with 2-4 yrs exp
in the pharmaceutical research field is required.
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Scientist
II/III Drug Characterization
Pharmaceutical company located in New York seeks a
Scientist II/III, Drug Characterization.
Position Summary: The analysis, disposition and release
of Excipients, Active Drug Substances (API) and Reference
Standards.
Description of Duties and Responsibilities:
" Analyze bulk pharmaceutical samples.
" Analyze excipient samples.
" Conduct analyses according to written protocols
for the performance of material characterization studies.
" Analyze finished pharmaceutical samples.
" Carry out investigations when necessary.
" Identify and provide resolution for complex problems
related to methodologies, sample analyses and laboratory
systems.
" Provide leadership and supervision for maintenance
tasks of the laboratory instruments.
" Provide training to junior level chemists on
basic operating procedures.
" Act a project manager for various laboratory
studies.
" Communicate in a professional manner with representatives
of contract laboratories.
Requirements:
" B.S. with 3-5 years or M.S. with 2-4 years of
Analytical experience in pharmaceutical field.
" Candidate must have first hand experience in
analytical instruments that include HPLC, GC, FTIR,
DSC, TGA and XRD.
" Candidate should have a broad knowledge of good
manufacturing practices (GMP).
" Candidate should have experience in Analytical
Method Development and Validation.
" Candidate should have the ability to work in
a project team environment, have excellent oral and
written communication skills.
There is no relocation program. Local candidates only.
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Research Scientist/Senior Research Scientist (Mass
Spectrometrist)
Well known pharmaceutical company located in New York
is seeking a Research scientist/Senior Research Scientist,
Mass Spectrometrist for the following responsibilities.
Responsibilities:
Thorough knowledge of chromatography and GC and HPLC
methods development and validation.
Thorough knowledge of mass spectrometry theory and the
practical experience to develop and analyze mass spectrometric
methods.
Thorough knowledge of the handling of LC/MS instruments
with a variety of ionization sources, in particular
APCI and Electrospray sources coupled to a single or
triple quadruple instrumentation, TOF or combination
thereof, on a routine basis
A thorough understanding of the data output from such
systems with a focus on data interpretation leading
to subsequent structural identification/determination
and possible quantitation.
Strong background from a practical perspective in Organic
Chemistry with Mass Spectrometry utilized as a primary
tool for structure elucidation
Be a team-oriented problem solver with excellent report
writing, presentation, and problem solving skills
Hands-on running and maintenance of the GC/MS and LC/MS
instrumentation, spectral and chromatographic interpretations
of the data generated, planning, organization and interpretation
of the experiments and results
Ability to comply with cGMP/GLP systems in laboratory
operations.
Education/Experience Requirements:
Ph.D. with publications in peer reviewed journals in
the field of Mass Spectometry and/or hyphenated techniques
including Mass Spectrometry
3-5 years of industrial experience that demonstrates
the ability to work in a problem-solving environment
in a mass spectrometry laboratory setting.
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Analytical
Preformulation Scientist
Analytical / Preformulation Scientist
Pharmaceutical company located in New York is seeking
an Analytical/Preformulation Scientist.
Job Responsibilities:
" Provide HPLC, LC/MS, LC/MS/MS project support
within the Pharmaceutical R&D departments
" Maintain instrumentation lab
" Conduct in vitro and/or in vivo studies to assist
in drug discovery and development
" Develop appropriate analytical methodology and
procedures
" Provide analytical instrumentation training to
chemists
Job Requirements/Education:
" Hands-on experience in analytical instrumentation
(particularly LC/MS/MS) is a must.
" Good understanding of in vitro techniques (bio-relevant
dissolution, cell culture absorption models) is highly
desirable
" Excellent verbal and written communication skills
" Must be able to work in a team environment in
a matrix organization
A B.S. or M.S. in Chemistry, Biopharmaceutics, Pharmaceutics,
or a related discipline with 2 - 7 years of relevant
pharmaceutical industry experience is required.
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CMC Manager
A pharmaceutical company located in Manhattan, NY is
seeking a CMC Manager.
Description of Duties and Responsibilities:
Manage all CMC activities with the Forest Laboratories
R & D organization to support drug development programs
" Direct the activities of a group of 4 to 6 scientists
and technical staff who are responsible for the preparation
of chemistry, manufacturing and control (CMC) documents
for FDA submissions
" Prepare, coordinate and manage the process of
assembling and submitting the CMC portion of Forest's
regulatory documents. This includes documents and information
required for IND and NDA submissions
" Serve as the principle representative of Forest
Laboratories in interactions with the Drug Regulatory
Affairs group and with the FDA on all CMC matters relating
to pharmaceutical development projects
" Develop and maintain a strong working knowledge
of CDER guidelines and the application of these guidelines
to the CMC portion of regulatory submissions
" Provide leadership in the migration to the CTD
format and e-Submission
" Coordinate activities and provide guidance for
internal functional groups to ensure acceptance and
fileability of documents
" Interact with scientists and technical staff
in the Analytical Chemistry and Formulations Development
Departments in an informative and collaborative fashion
which supports pharmaceutical development
" Provide oral and written reports as necessary
to R & D management on matters relating to CMC activities
" Provide benefit/risk assessments to senior management
Requirements:
" BS/MS in Analytical Chemistry or related discipline
with 6-10+ years of relevant experience
" Strong working knowledge of CMC activities including
CDER guidelines
" Excellent oral and written communication skills
" Orientation to detail and a recognition of the
importance of accurately interpreting and applying regulatory
guidelines
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Senior
Scientist / Principal Scientist
A
pharmaceutical company located in CT is seeking a Senior
Scientist/Principal Scientist for the following responsibilities:
" Develop analytical methods.
" Participate in method transfer process to QC.
" Provide analytical support to R&D.
" Perform literature searches in support of projects.
" Analyze samples.
" Participate in project driven teams.
" Provided training and mentoring.
Requirements:
" 2-10 years of experience in method development
in the pharmaceutical or biotechnology industry, specifically
for small molecule and protein analysis.
" 5-10 years of experience and chromatographic
or other separation techniques with varied detection
technologies (HPLC, GC, SEC, CE, LC/MS, LC/tandem, MS,
etc).
" 2-5 years of method validation/GMP experience.
" Basic knowledge of organic chemistry.
" 1-3 years of Mass Spectrometry experience (single
and/or tandem).
" Experience with Empower and MassLynx Software
for Waters HPLC and LC/MS systems.
" PhD in analytical chemistry with 2 years pharmaceutical/biotechnology
experience; MS in chemistry with 5 years pharmaceutical/biotechnology
experience; or BS in chemistry with 10 years of pharmaceutical/biotechnology
experience.
" Excellent oral and written communication skills.
" Ability to function both independently and in
a team environment.
" Familiarity with Perking-Elmer GC.
" Familiarity with Capillary Electrophoresis.
" Familiarity with binding studies.
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