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 purpose of this laboratory-based position is to develop, qualify, validate and transfer clinical assays in support of Vaccine Programs. Develop assays using techniques based on the inherent attributes of the analytes, including biological, functional, chemical, or physical properties. The incumbent is responsible for writing/reviewing technical reports and protocols that describe the test methods, experimental results, or the operation of laboratory instruments. Participates in the qualification of laboratory instruments where applicable. Ensures the accuracy, completeness, and compliance of all data and tests results. Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Pfizer Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.
* Working under the supervision of a more senior scientist or manager, the incumbent develops, qualifies and validates assays in support of Vaccine Programs. Assay development uses a variety of technologies and exploits inherent properties of the analyte. Assay qualification and validation are consistent with ICH guidelines.
* Tests samples to support assay development and GLP studies. Characterizes or qualifies critical assay reagents and standards.
* Writes and reviews technical documents including, but not limited to, test protocols, development reports, qualification reports, and experimental summaries. Prepares external presentations and publications, and patents.
* Performs daily, weekly and monthly laboratory activities, such as daily and weekly monitoring of equipment, completion of equipment logbooks, periodic laboratory cleaning and managing the laboratory waste, checking PMO status of laboratory equipment and reporting discrepancies to management. Maintains all experimental data in laboratory notebooks and reviews data and laboratory notebooks of other analysts.
* Satisfactorily completes all job related training in conformance with Departmental requirements. Where applicable, performs job responsibilities in compliance with GLP and all other regulatory agency requirements.
* Performs other duties as assigned.
* Requires a minimum of 8+ years of relevant experience with a BS Degree or 6+ years with a Master's Degree with experience in academic research, biopharmaceutical R&D, or government laboratories.
* Experience with assay development and qualification is a must.
* Experience with a variety of analytical technologies is necessary.
* Skills in planning and organization and the ability to work with minimal supervision are required.
* Knowledge of assay development, qualification and validation. Training or experience in a variety of analytical platforms applicable to biomolecules. Training in basic laboratory techniques, laboratory safety, computer operation and software, and technical writing skills.
Colleague will need to work on site which involves: lifting, sitting, standing, walking, ability to perform mathematical calculations and ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Colleague will need to work on site which involves: unusual attendance requirements, weekend work or travel requirements
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.