Pfizer Senior Scientist, Assay Development in Andover, Massachusetts
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.
• Laboratory focused bioanalytical position
• Design, develop and implement cell based, ligand binding based and PCR 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 Viral Gene and Cell therapy based modalities.
• High degree of independence in design, trouble shooting and conduct of the assay to support programs
• Responsible for the development of robust and reliable ligand binding, cell based and PCR based assays in biological matrices
• 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
• MS with at least 10+ year relevant experience, PhD with 2+ years of relevant experience
• Industry experience with a focus in biotherapeutics development
• Industry experience with a focus in biotherapeutics and a strong record of scientific achievement
• Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of 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 developing PCR based assays, including qRT PCR, cDNA analysis, primer design, RNA and DNA isolation, cloning and sequencing
• Knowledge and hands on experience working with various mammalian cell lines, developing cell based assays, including use of various read out protocols, cell culture relevant technologies e.g. cell culture generation and characterization
• Familiarity with assay qualification, validation and when required sample analysis.
• Solid understanding of Immunogenicity and exposure assays including PCR, LBA and Flow Cytometry based
• Knowledge and hands-on experience developing ligand binding assays, utilizing
various platforms including, but not limited to MSD, ELISA. Also understanding of Genalyte, Wes, Octet HPLC, PAGE is a big plus
• Familiarity with the Design of Experiment approach to assay development and troubleshooting
• Familiarity with ADA assay development including principles behind assay sensitivity and cutpoint determination
• Understanding of bioinformatics principles, DNA, mRNA and amino acid sequence mining, ability to generate and analyze peptide maps
• Familiarity with working under GLP/GCP regulations, including electronic lab notebook
• Broad understanding and skill in areas of bioanalytical laboratory techniques for biotherapeutics.
• 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
• Excellent teamwork
• Interpersonal and communication skills
• Able to identify opportunities for continuous improvements and enable
• Ability to work across a matrix team
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.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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.