Laboratory Scientist-Analytical Development

We are searching for a Laboratory Scientist-Analytical Development to support and/or development and validation of methods to test new products manufactured at the site. Design testing of experimental, confirmation and registration lots, stabilities and new supplier certifications. Participate and/or develop the transfer of analytical technology to the commercial laboratories. Primary functions:

Designs experiments to generate analytical methods suitable to support formulation developmentDevelops and validates cleaning and analytical methodsPerforms compendial methods evaluation and prepares verification protocols and reportsEvaluates the data generated by laboratory technologist and or laboratory analysts and trendsAssures all the information regarding to the testing activities is documented on a timely manner in the corresponding laboratory logbooks and laboratory notebooksPrepares API, Raw Materials and Finished Product Specifications and Analytical MethodsEvaluates Technical Transfer Packages and prepares Analytical Method Transfer Protocols and Reports.

Evaluates raw data, perform troubleshooting of analytical methods and oversee laboratory work performed by laboratory analyst and technologistsPerforms or supports laboratory investigations as requiredPrepares progress reports and participate in Staff MeetingsActs as a backup contact for the Analytical Development ManagerRevises SOPs and keeps track of the weekly scheduleProvides training to laboratory analyst and laboratory technologist as needAssures that files and records are maintained up to dateSupports EHS program to assure compliance with safety policiesInterprets results obtained during method development and troubleshoot tests as neededEnsures compliance with current pharmacopeia, FDA and ICH guidelinesUpdates specifications and test methods as neededProvides scientific coaching to laboratory personnel, such as training in specific analysis techniques, protocol instructions, and method development technics among othersPrepares laboratory deviation reportsPerforms any other duties as assignedMinimum Requirements:

Bachelor's Degree in Chemistry (Analytical, Organic or Pharmaceutical)Eight (8) years of related experience in analytical laboratoryExperience in method validation (preparation of protocols and reports), analytical technology transfer and cleaning validation are required for pharmaceutical small moleculesExperience in a cGMP regulated analytical laboratoryKnowledge in FDA, ICH and USP requirementsHands on experience in analytical method validationsProficient in the use of LIMS systemExercise attention to detailStrong technical writing skillsCapable to read and interpret correctly scientific and technical literatureExcellent communication skills in English and SpanishOther Requirements: Flexible to work flexible shifts including weekends"Drug Free Workplace Policy:

In accordance with our commitment to maintaining a safe and productive work environment, all applicants for employment with our company are required to affirm their commitment to a drug-free workplace and consent to pre-employment drug testing as a condition of employment. "Share Tech Group is committed to being an equal opportunity employer, fostering a diverse and inclusive workplace where all individuals are treated with respect and provided with equal opportunities for employment and advancement. Powered by JazzHRVAFtr49mjH