Extractables & Leachables Sr Analytical Chemist in Lake Forest job in Lake Forest
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About Pfizer |
A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The analyst will primarily be responsible for laboratory activities (e.g. analytical method development, validation and transfer) for assigned projects, including but not limited to developing timelines and work plans. This position normally reports to a group leader. The incumbent will support product development, specifically extractable/leachables and impurity Identification. This individual also assists with preparing and reviewing technical documents, including validation protocols and reports, analytical test procedures and technical reports. Independently performs all chemistry technique assignments including chromatography and mass spectrometry, and is able to troubleshoot all analytical instrumentation. Routinely designs complicated experiments that lead to a fundamental understanding of drug's stability characteristics as a function of the designated drug delivery system. Makes routine use of scientific literature, and has a good understanding of the disciplines beyond chemistry and pharmaceutics. Effectively functions as a PEH PharmSci representative on project teams.
*Leads and plans analytical laboratory assignments and activities to meet established project goals and timelines. Provides formulation support in developing new products. *Designs and executes studies to meet requirements in USP and . *Directly or through others, performs analytical method development, and executes method validations and method transfers. *Supports developmental and execution of special studies (eg, extractable/leachables, impurity identification/profiling, forced degradation, etc.). *Prepares and reviews technical documents, including validation protocols and reports, analytical test procedures, technical reports, and change controls. Provide the necessary documentation for regulatory submissions as required and writes deficiency responses *Ensures that the analytical procedures they develop, review or establish conform to current and appropriate scientific, compendial and regulatory standards, and are suitable for use for their intended purpose. *Conducts investigations in the areas of method performance and reliability and evaluates proposed changes to compendia or developed methods. *Writes protocols or propose specifications based on USP, ICH or other compendial or regulatory requirements. *Assists in performing laboratory investigations. *Work directly with parties beyond PEH PharmSci/R&D, including but not limited to 3rd party analytical labs, Contract Manufacturing Organizations (CMO's), and involvement with other divisions of Pfizer. *Provides training, technical expertise and support to the analytical staff. *Identifies opportunities for quality enhancement and operational efficiencies and develops efficient methodologies to track the progress. *Evaluates new or state-of-the-art technology for potential use for characterization and assessment of key drug product attributes. *Performs duties with a high level of independence.
*Bachelor's degree in the physical or biological sciences with 10+ years of experience, MS with 5-7 years of experience, or Ph.D. with 1-3 yrs of experience. Experience in a cGMP laboratory is a plus. *Must have strong experience in chromatography, mass spectrometry, and other spectroscopic techniques. *Experience with polymers and material selection for container closure systems or devices is a plus. *Strong written and oral communication skills and the use of MS Office (Word, Excel) are required
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
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