PDM NBE Bioanalytical Scientist/Senior Scientist Job in Andover, Massachusetts US

PDM NBE Bioanalytical Scientist/Senior Scientist

Org Marketing Statement Pfizer Inc: Working together for a healthier world Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Job Focus Responsible for the development and validation of robust and reliable ligand binding assays suitable for characterizing the disposition and immunogenicity of biotherapeutics in various matrixes using a range of potential screening platforms and assay techniques. Responsible for the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programs. Timely delivery of concentration and immunogenicity data to PDM BioTX principal investigators and other partners. Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for early and late stage assets. Development and validation of assays to be governed per departmental SOP. Accurate execution and documentation of bioanalytical method in a regulatory compliant manner. Knowledge of GLP/GCP and working in a regulated environment is highly desirable. Responsibilities Design, develop and implement ligand binding assays (e.g. ELISA, ECL detection) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity in a dynamic environment Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making. Gathers input from colleagues, literature, and additional resources to assist in driving the project forward. Qualifications BSc with at least 5+ years relevant experience, with a focus on ligand binding assay development preferably in a GLP/GCP laboratory (R3); MSc with at least 3+ years relevant experience with a focus on ligand binding assay development preferably in a GLP/GCP laboratory (R4). Industry experience with a focus in biotherapeutics and a strong record of scientific achievement; excellent communication skills. Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of bioanalytical platforms. Skills in GLP/GCP compliant analysis including following SOP and provision of quality regulatory documents is highly desirable Proven presentation skills. Technical Skill Requirements: Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms and demonstrated analytical problem solving skills. Knowledge and hands on experience working under GLP/GCLP regulations is highly desirable Broad understanding and skill in areas of bioanalytical laboratory techniques for biotherapeutics. Proven ability to work independently to generate high quality data against challenging time lines Ability to communicate across site and discipline to enable maximum impact of bioanalytical science. Knowledge of biotherapeutic structure, pharmacology, disposition and immunogenicity and the impact on assay selection. Ability to author technical documents like SOPs, data summary reports and analytical procedures. Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model. Experience working with mammalian cells and cell based assays a plus. Equal Employment Opportunity 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 employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer. *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Pfizer prefers that you apply to this job directly on their site