🚀 go-pugleaf

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 Large parenteral drug manufacturer located in the greater Chicago
metro area has two openings in the Analytical Development Dept. The
company has a need for method development and stability chemists.

Function:
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  To carry-out method development, validation and required
documentation for new drug substances, drug products and excipients.
To supply properly formatted documents to be used as part of the CMC
section of ANDA/AADA/sANDA/sAADA applications.

Responsibilities:
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*  Carry-out laboratory studies as part of the validation of
analytical methodology (primarily HPLC methods).

* Document all laboratory work in an accurate, comprehensive, and
cGMP-compliant manner.

* Perform routine and nonroutine chromatographic and
spectrophotometric drug substance and product analyses. Perform
routine stability analytical studies on new and existing drug
products.

* Assist in preparing research reports, analytical methods, SOPs,
regulatory responses, and various procedural manuals.

Qualifications:
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* BS or MS in chemical or biological science with 2-4 years
professional experience in pharmaceutical analysis or related
analyticalm discipline.

* Familiarity with common laboratory equipment such as HPLCs, GCs,
spectrophotometers, titrimeters, pH meters and laboratory automation.
Good working knowlege of computer hardware and software is desireable.

* Familiarity with official test methods such as USP, AOAC, FCC and
other international sources.

* Good oral and written communication skills are required. Excellent
interpersonal skills are also a plus.

* Good working knowledge of cGMPs and GLPs as applied to laboratory
activities.

Reporting Relationship:
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Reports to:     Senior Analytical Chemist or Section Head
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E-mail responses with attached resumes in text or ASCII format to
rkirsch@ix.netcom.com

Thank you.