Date: 06-Aug-2015
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Sr. Research Scientist I
Description of KEY responsibilities (describe the main results of the job to be achieved):
Assists in the development of robust methods for the analysis of API and excipients.
Efficiently carries out method validation experiments. Prepares protocols and reports.
Performs analyses on various sample types (drug substance, excipients) and using various techniques (chemical and physical testing) in a safe, efficient and compliant manner.
Coordinates the execution of analyses of various sample types in-house and through contract laboratories as needed.
Participates in investigations and completes all required documentation in a timely manner.
Writes or contributes to the design of SOPs.
Participates actively on project teams.
Keeps accurate notebook records in accordance with SOP and cGMP requirements.
Keeps management informed of all significant developments. Proposes solutions to problems.
Experience and education required
PhD + 8 or Masters +12 or Bachelor’s +20 years’ of relevant experience
Skills and specific knowledge required
Strong background, advances knowledge and extensive experience in Analytical Chemistry with emphasis on routine testing, method verification, development and validation, preferably in a regulated industry.
Strong practical knowledge of chromatography (UPLC, HPLC, GC, TLC), wet chemistry (ROI, Heavy Metals, Titrations, etc.), spectroscopy (UV, FTIR), compendial test methods and related techniques.
Knowledge of genotoxic impurities, setting limits appropriate for stage of development
Proficient in troubleshooting and planning of laboratory tasks.
Able to work independently, and to guide the work of other junior scientists, with or without a reporting relationship.
Strong communication and technical writing skills.
Background or coursework in Analytical Chemistry with applicability to routine testing and method development and validation.
Working knowledge of USP and other pharmacopeia
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Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
