Senior / Principal Scientist, Regulated Bioanalytical Assay
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
- Responsible for the development of robust and reliable ligand binding and /or cell-based assays suitable for characterizing the disposition (PK) and Immunogenicity of biotherapeutics in various matrixes using a range of potential platforms and assay techniques.
- Responsible for the design of bioanalytical strategy for support of biotherapeutic programs, trouble shooting of assay issues, assay validation and conduct of the assays to support biotherapeutic programs. Timely delivery of drug concentration and immunogenicity data to PDM BioTX principle investigators and other partners in compliance with local or global regulatory requirement.
- Championing bioanalytical capabilities within the Andover Bioanalytical group to improve efficiency, cost effectiveness and appropriateness of assay for regulated support.
- Responsible for scientific oversight of outsourced biotherapeutics assay validation and sample testing.
- Development and validation of assays to be governed per departmental SOP. Accurate execution and documentation of bioanalytical methods in a regulatory compliant manner. Ensure GLP/GCP compliance is maintained in laboratory during study support.
- Lead design of appropriate strategy of bioanalysis for Biotherapeutic compounds. This includes,
- The design, development and implementation of ligand binding assays (e.g. ELISA, ECL detection) to measure compound concentration, detection the presence of anti-drug antibody and neutralizing anti-product antibody activity in a regulated environment; Lead:
- The design, development and implementation of appropriate cell-based assays.
- Data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making.
- Gathering input from PDM colleagues, other departments, literature, and additional resources to assist in driving the project forward.
- Supervise and mentor junior scientists in the above activities
- MSc with at least 10+ years relevant GLP/GCP industry laboratory experience with a focus on ligand binding assay development; cell-based assay experience. Ph.D. with at least 2+ years relevant GLP/GCP industry laboratory experience with a focus on ligand binding assay development; 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 complient analysis including following SOP and provision of quality regulatory documents.
Proven presentation skills.
TECHNICAL SKILL REQUIREMENTS
- Knowledge and hands-on experience developing ligand binding assays, utilizing various technology platforms.
- Broad understanding and skill in areas of bioanalytical laboratory techniques for biotherapeutics
- Knowledge and experience working with mammalian cells.
- Knowledge and hands on experience working under GLP/GCP regulations
- 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 like SOPs, data summary reports and analytical procedures.
Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model.
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.
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MassBio is a not-for-profit organization committed to advancing the development of critical new science, technology and medicines that benefit people worldwide.
Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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