Assoc Scientist - HPLC - GC - Dissolution

PPD

(Waltham, Massachusetts)
Full Time
Job Posting Details
About PPD
PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.
Responsibilities
* Performs a variety of routine to complex sample preparation and analysis procedures to quantitatively measure pharmaceutical compounds in a variety of formulations and/or biological matrices. * Follows validated or experimental analytical procedures with periodic direct supervision. * Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol and product specifications. This position will be primarily focused on analysis of small molecule drug substances, drug substance intermediates, and drug products (solid oral dosage forms as well as sterile products). The work will involve both cGMP and non-GMP analysis using a suite of analytical methodologies, including: * High performance liquid chromatography * Gas chromatography * Dissolution * Water content by Karl Fisher Disintegration * Tablet hardness * Friability * Vibrational spectroscopy (e.g. infrared and Raman) * Particle size by laser diffraction * Surface area * Differential scanning calorimetry
Ideal Candidate
**Education and Experience:** * Bachelor's degree or equivalent and relevant formal academic / vocational qualification * Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable 1 year) or equivalent combination of education, training, & experience.). **Knowledge, Skills and Abilities:** * Knowledge of applicable regulatory authority, compendia and ICH guidelines * Ability to understand and independently apply GMPs and /or GLPs to everyday work with regard to documentation and instrument use * Ability to utilize Microsoft Excel and Word to perform tasks * Ability to independently optimize analytical methods * Good written and oral communication skills * Time management and project management skills * Problem solving and troubleshooting abilities * Ability to work in a collaborative work environment with a team

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