About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company 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. the company, 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.
• Leading role in design of bioanalytical strategy in support of large molecule project development
• Responsible for the development of robust and reliable Ligand Binding and cell based assays suitable for determining drug concentration, detection and characterization of anti-drug antibodies in various matrixes using a range of bioanalytical platforms
• Responsible for the design, troubleshooting, validation and where required conduct of the assays in support of non-clinical and clinical studies for biotherapeutic programs
• Development and validation of assays to be governed per departmental SOPs.
• Accurate execution and documentation of bioanalytical methods in a regulatory compliant GLP and GCP manner. Ensure GLP compliance is maintained in laboratory during study support
• Timely delivery of data to study Principle Investigators and other partners in compliance with local or global regulatory requirement
• Responsibility for management, oversight and mentorship of BS/MS level scientists
• Advancing bioanalytical capabilities to improve efficiency, cost effectiveness and appropriateness of assay for regulated support
• Influence the advancements of biotherapeutic science externally and internally
• Design, develop and implement ligand binding assays (e.g. ELISA, ECL and others) assays to measure biotherapeutic drug concentrations, detect and characterize of anti-drug antibodies, neutralizing anti-product antibodies.
• Operate in GLP / GCP regulated environment, follow company SOPs and Regulatory guidelines
• Review and approve data generated by direct reports
• Author and review as required Bioanalytical procedures, assay validation reports, study reports and other relevant documentation.
• Perform data analysis and interpretation and be able to draw conclusions regarding progress and results of work, utilizing the data in appropriate decision making
• Actively maintain GLP / GCP status of the group.
• Author, maintain and review SOPs and other regulated documentation as needed
• Proactively gather input from colleagues, literature, and additional resources to assist in driving the project forward.
• Manage activities, mentor junior group members
• PhD with several (6+) year of relevant and direct industry experience with a focus on bioanalysis of biotherapeutics
• Strong record of scientific achievements; excellent communication skills
• Proven track record in the area of biotherapeutics bioanalysis with understanding of a broad range of LBA platforms. Understanding of Cell based assays is a plus
• Direct experience in GLP/GCP compliant assay validation and sample analysis
• Direct experience in formulating strategy and monitoring group compliance strategy, identifying gaps and required solutions
• Excellent communication and presentation skills
Technical Skill Requirements
• Deep knowledge of principles, concepts and practices in Regulated BA discipline
• Demonstrated extensive direct experience in assay design, troubleshooting, development, validation and study support
• Demonstrated direct experience in mentorship/supervision of junior level scientists
• Demonstrated experience in GLP / GCP aspects, including internal and external regulatory documents
• Demonstrated achievements in advancing of bioanalytical science internally and externally
• Demonstrated track record of publications and posters
• Understanding of other scientifically relevant disciplines and functions
• Direct experience in interacting with external organizations, including CROs
• Solid familiarity with 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
• Strong adaptability to changing work assignments and priorities
• Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model
• Excellent teamwork
• Excellent interpersonal and communication skills
• Able to identify opportunities for continuous improvements and enable implementation
• Ability to work across various matrix teams
Other Information - Internal
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.
EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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