Pfizer Senior Scientist, Biotherapeutics in Andover, Massachusetts
Senior Scientist of Biotherapeutics is a laboratory focused bioanalytical position responsible for the design, development and implementation of Ligand Binding and ELISPOT based assays in biological matrices to measure exposure, detect presence of binding and neutralizing anti-product antibodies. Interaction with internal and external groups, departments focused on support of Viral Gene and cell Therapy modalities. Perform data analysis and interpretation, be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making. Proactively gather input from literature, colleagues, additional resources to drive projects forward. Work in a regulated (GLP, GCP) environment
Hands on and highly independent laboratory position. Activities related to bioanalytical support of biologicals High degree of independence in design, trouble shooting and conduct of the assay to support programs Responsible for the development of robust and reliable ELISPOT and Ligand Binding assays in biological matrices. Understanding theory and practice behind ELISPOT application. Demonstrated understanding and knowledge of practical immunology. Ability to establish Bioanalytical strategy and project support priorities through collaboration with Clin Pharm rep, Clinical assay group and Biomedicine design colleagues Timely delivery of exposure and immunogenicity assays, when applicable - timely delivery of relevant study data to Project PI and other partners in compliance with local or global regulatory requirement Readiness to function as a Bioanalytical Principle Investigator for relevant projects As needed, direct or indirect oversight of junior staff to ensure appropriate support is in place and executed. Be a direct resource for junior staff Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support. Adherence to departmental SOPs, ensuring appropriate level of GLP and GCP compliance Influence the advancements of biotherapeutic science externally and internally Responsible for providing appropriate documentation to ensure highest compliance level as the supported bioanalytical work includes regulated non-clinical and clinical phase.
PhD with 2+ years of relevant experience or MS with 10+ years relevant experience
Industry experience with a focus in biotherapeutics and a strong record of scientific achievement
Proven track record in the area of relevant bioanalytical platforms
Understanding of GLP/GCP compliance as related to bioanalytical support for biologics
Excellent oral and written communication skills, including strong publication record, presentations at local and international meetings
Technical Skill Requirements
Must have high level of knowledge and hands on experience in developing ELISPOT and Ligand Binding based assays
Strong understanding of theory behind Immunology and Immunogenicity of biologics
Current experience working under GLP/GCP regulations
Knowledge and experience working with mammalian cells is a plus
Familiarity with assay qualification, validation and when required sample analysis
Familiarity with ADA assay development including principles behind assay sensitivity and cut point determination
Proven experience generating analytical data in a regulated environment
Proven analytical problem solving skill.
Proven ability 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, e.g. SOPs, data Summary Reports and Bioanalytical procedures
Adaptability to changing work assignments and priorities
Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model
Interpersonal and communication skills
Able to identify opportunities for continuous improvements and enable implementation
Ability to work across a matrix team
Additional Offer Details
Last Date to Apply for Job: July 31, 2017
Eligible for Employee Referral Bonus
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