Pfizer Diagnostics Operations Lead in Cambridge, 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.
Provide vendor oversight support to Companion Diagnostics (CDx) programs across the R&D Organization, from Research to Development and Commercialization.
Provide oversight of CDx assay programs contracted to Clinical Laboratories/Contract Research Organizations (CROs) to ensure they meet all regulatory requirements.
Provide Operational support to CDx programs, Diagnostics Group members and members of other Pfizer groups collaborating on CDx development and delivery.
Qualification of contract labs and Diagnostics partners for CDx assays.
Provide direction to and oversight of CDx assay work performed at external CROs.
Assist in the transfer of diagnostics assays developed internally at Pfizer to external CROs or Diagnostics companies.
Coordinate operational aspects of CDx implementation in clinical trials (all phases). Manage to established timeframes and communicate progress to study teams, as appropriate.
In conjunction with internal groups (e.g. Precision Medicine and Translational groups), ensure that appropriate information on CDx sample collection/processing/handling is incorporated into lab manuals.
Responsible for assay validation reports (except when internal Pfizer groups have developed such assays), to ensure laboratories are performing analysis in compliance with appropriate regulatory and industry standards.
Stay abreast of literature, government guidelines, and internal guidance on clinical trial conduct including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), GCLP, CAP and CLIA.
Maintain and abide by internal SOPs and regulations, as appropriate, for diagnostics assay development and testing.
Periodically audit external CROs performing CDx assays that support Pfizer programs.
Maintain required paperwork from such audits in relevant Pfizer electronic databases.
Working with Procurement, coordinate critical orders required to keep CDx programs on track Contribute to the operational effectiveness of the Diagnostics Group.
Advanced science degree (e.g. MS, PhD, PharmD) and/or a degree in regulatory compliance/oversight related field.
Demonstrated understanding of regulatory requirements and application of quality systems (GLP, GCP, GCLP, CLIA, CAP).
In depth knowledge and experience in diagnostics, particularly companion diagnostics
3+ years of relevant regulatory compliance/oversight experience in a setting relevant to drug development.
Demonstrated excellent writing and communication skills.
In depth and hands-on experience in one or more technology platforms relevant to CDx assay development, such as immunohistochemistry, PCR, next generation sequencing, immunochemistry.
Extensive hands-on experience with compliance/oversight of diagnostics assays.
Experience in biomarker development or diagnostics industry preferred.
EEO & Employment Eligibility
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.
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Other Job Details:
- Last Date to Apply for Job: June 28, 2018
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.