Pfizer Scientist in Andover, Massachusetts

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.

Role Description

Work under supervision of a Senior Scientist with high degree of independence *Responsible for the development of robust and reliable ligand binding in biological matrix (plasma, serum) and /or cell-based assays suitable for characterizing the disposition and immunogenicity of biotherapeutics in various matrixes using a range of potential screening platforms and assay techniquesHigh degree of independence in the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programsTimely delivery of concentration and immunogenicity data to PDM BioTX principal investigators and other partners in compliance with local or global regulatory requirement.Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support Development and validation of assays to be governed per departmental SOP.Accurate execution and documentation of bioanalytical method in a regulatory compliant manner. *Ensure GLP compliance is maintained in laboratory during study support

Responsibilities

Laboratory focused position *Design, develop and implement ligand binding assays (e.g. ELISA, ECL detection) in biological matrix (plasma, serum) to measure compound concentration, detect the presence of anti-drug antibody and neutralizing anti-product antibody activity in a regulated (GLP, GCP) environment.Participate in the design, development and implementation of cell-based assays.*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. Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.

Qualifications

BSc with at least 7 years relevant GLP/GCP laboratory experience, with a focus on ligand binding assay development in biological matrix (plasma, serum) and/or cell-based assay experience; MSc with at least 5 years relevant GLP/GCP laboratory experience with a focus on ligand binding assay development in biological matrix (plasma, serum), cell-based assay experience.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.Excellent communication and presentation skillsTechnical Skill RequirementsKnowledge and hands-on experience developing ligand binding assays, utilizing various platforms. Knowledge and hands on experience working under GLP/GCP regulationsKnowledge and experience working with mammalian cells is a plusBroad understanding and skill in areas of bioanalytical laboratory techniques for biotherapeutics.Proven experience generating analytical data in a regulated environmentProven analytical problem solving skill.Proven ability to generate high quality data against challenging time linesAbility 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, e.g. SOPs, data Summary Reports and Bioanalytical proceduresBehavioral CompetenciesAdaptability to changing work assignments and prioritiesCollaborative skills and effective partnering skills in a complex, multi-discipline organizational model *Excellent teamworkInterpersonal and communication skillsAble to identify opportunities for continuous improvements and enable implementationAbility to work across a matrix team

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.

Scientist Andover, Massachusetts 1040707