US-MA-Lexington: Senior Scientist in Biotech

[http://biotech.fyicenter.com]

US-MA-Lexington: Senior Scientist in Biotech
To apply for this position, please visit this Website.
http://biotech.fyicenter.com/jobs/99890010_Senior_Scientist_in_Biotech.html
Date: 01-May-2012
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Senior Scientist, Analytical Development, Drug Substance

* Develop and implement methods for in-process testing, process
characterization, and release testing. * Supervise and direct the
validation of API release methods and release testing at external
contract labs, working to aggressive timelines. * Work closely with
process development chemists to propose and justify specifications and
release tests for GMP material. * Work closely with process
development chemists to generate and interpret analytical data to
provide enhanced understanding and guidance around process chemistry
reactions and downstream processing steps. * Ensure and maintain an up-
to-date familiarity with and knowledge of all relevant regulatory
guidance. * Participate in cross functional project teams focused on
drug substance development activities. * Perform or coordinate small
scale isolation of impurities as well as collaborating with process
chemistry groups for larger scale isolation as necessary * Elucidate
structures of impurities in intermediates, drug substances and drug
products. * Identify and execute or coordinate physicochemical testing
required to characterize intermediates, drug substances to support
development stage programs. * Collaborate with non clinical
development group to identify qualified impurities limits of GI/PGI’s,
process and degradent impurities as well as investigating test article
strategies for qualifying drug substance and drug product related
impurities during toxicology studies. * Collaborate with drug
substance development groups to review manufacturing process schemes
to identify potential genotoxic impurities, and identify testing
points and control strategies * Conduct stress studies to understand
degradation pathways associated with development compounds and
communicate relevant information to the drug substance process
development and drug product development groups. * Author structure
elucidation, impurities and physicochemical technical reports and
sections in regulatory filing documents. * Assist analytical
development team members focused on life cycle management of HPLC
purity assays used to monitor individual impurity levels in drug
substances and drug products during toxicology studies and clinical
phase development. * PhD in Analytical Chemistry, Organic Chemistry or
a related discipline with a minimum of 6 years pharmaceutical/biotech
experience in analytical method development and structure elucidation
of pharmaceutical compounds. * Demonstrated expertise in
chromatography and separation science. * Strong understanding of small
molecule structure elucidation, guided and informed by knowledge of
organic chemistry. * Experience with HPLC method development and
validation and Waters Empower software. * Experience managing testing
performed at GMP and non-GMP contract labs. * Experience in a wide
variety of structure elucidation and physicochemical techniques
including mass spectrometry, 1D and 2D NMR, FTIR, GC, GC-MS, pKa,
elemental analysis, ion chromatography, etc. * Demonstrated ability to
analyze and interpret analytical data. * Strong familiarity with and
understanding of USP monographs and chapters, and ICH/FDA guidance
documents related to analytical method validation, impurities,
genotoxic impurities, etc.

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