Pfizer Senior Scientist, Biotherapeutics 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.

• Hands on and highly independent laboratory activities related to Large Molecule Biotherapeutic PK and Immunogenicity (ADA and NAb) assay development, validation and when required sample analysis. Independence in the design, trouble shooting, validation and conduct of the assay to support biotherapeutic programs

• Function as a Bioanalytical Principle Investigator

• With limited support from a Senior Scientist to establish Bioanalytical strategy and project support priorities

• Direct or indirect oversight of junior staff to ensure appropriate support is in place and executed. Be a direct resource for junior staff Responsible for the development of robust and reliable ligand binding assays in non-clinical and clinical biological matrices suitable for characterizing of exposure and immunogenicity of biotherapeutics using a range of potential screening platforms and assay techniques.

• Familiarity with cell based platforms and technologies is a big plus

• Experience with Automated Liquid Handling equipment for LBA protocols is a big plus Responsible for the development of robust and reliable ligand binding assays in non-clinical and clinical biological matrices suitable for characterizing of exposure and immunogenicity of biotherapeutics using a range of potential screening platforms and assay techniques.

• Familiarity with cell based platforms and technologies is a big plus

• Experience with Automated Liquid Handling equipment for LBA protocols is a big plus Responsible for the development of robust and reliable ligand binding assays in non-clinical and clinical biological matrices suitable for characterizing of exposure and immunogenicity of biotherapeutics using a range of potential screening platforms and assay techniques.

• Familiarity with cell based platforms and technologies is a big plus

• Experience with Automated Liquid Handling equipment for LBA protocols is a big plus

• Timely delivery of concentration and immunogenicity data to Project 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.

• Ensure GLP and GCP compliance is maintained in laboratory during study support

• 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

• Laboratory focused position

• Interaction with internal and external groups and departments

• Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making

• Proactively gather input from literature, colleagues and additional resources to assist in driving projects forward

• 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.

• As needed, participate in the design, development and implementation of cell-based assays.

• 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.

• MS with at least 10+ year relevant experience

• Industry experience with a focus in biotherapeutics development

• 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.

• Hands on skills in GLP/GCP compliant analysis including following SOP and provision of quality regulatory documents.

• Excellent communication and presentation skills

Technical Skill Requirements

• Knowledge and hands-on experience developing ligand binding assays, utilizing various platforms.

• Knowledge and hands on experience working under GLP/GCP regulations

• Knowledge and experience working with mammalian cells is a plus

• Broad understanding and skill in areas of bioanalytical laboratory techniques for biotherapeutics.

• 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

Behavioral Competencies

• 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 implementation

• Ability to work across a matrix team

Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

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.