This position will provide biomarker bioanalytical support for regulated clinical studies for Pfizer clinical studies. This senior scientist will act as technical scientific expert providing method development, validation and study support using ligand binding based assays for both small and large molecule programs.
In addition this position will provide supervision of laboratory staff including responsibility for colleague training, guiding project support, performance management aspects, technical/scientific supervision, data QC review and approval, and insuring conduct of compliance related activities of direct reports.
Responsible for providing Ligand Binding based analytical data for biomarker discovery and development, supporting assay method development, validation and study execution.
Demonstrate experience in the delivery of ligand binding based biomarker data in clinical studies, have strong knowledge of bioanalytical methodologies as related to ligand binding assay platforms, sample preparation techniques, and a basic knowledge of immunoanalytical principles in alignment with these assays for both small and large molecule compounds.
This role will participate the oversight of regulatory laboratory operations including the development of sample preparation strategies, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
Colleagues in this role are responsible for maintaining regulatory compliance appropriate for clinical and preclinical study execution including all proscribed training as found in ECD SOPs and training transcripts.
Participate in continuous improvement of scientific and regulatory processes via update/creation of SOP’s, design and implementation of laboratory and study based processes, and development of best practices for bioanalytical data generation.
Responsible for QC and peer review of raw data, results, and final reports from other colleagues within the regulated lab group. Also responsible for participation in internal audits providing required information to auditors as needed.
Other responsibilities include independent planning of laboratory activities, understanding and influencing therapeutic area strategies at the clinical team level.
Provide supervision of laboratory staff including responsibility for insuring colleague training, performance management, technical supervision, data QC, review, and document approval, and insuring conduct of compliance related activities of direct reports.
Responsible for conduct and oversite of day to day laboratory activities, insuring laboratory safety requirements are met and compliant with Pfizer requirements.
Manage and assign project work to laboratory staff, assist with maintenance of project sheets, ensure study progression, and provide open scientific consultation/mentoring and coaching with direct reports.
PhD. degree in Biology or another related field with 6-10 years of regulated laboratory experience in pharmaceutical or CRO settings.
M.S. with 8+ years of regulated laboratory experience in pharmaceutical or CRO settings.
Other Job Details:
Eligible for Relocation Package
Eligible for Employee Referral Bonus
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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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.
Internal Number: 4763506
About Pfizer Inc.
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.
At Pfizer, we’re driven to discover the cure—driven to significantly improve the lives of everyone...everywhere. If you’re similarly driven, you’ll find there’s no better place to begin—and continue—your career than at Pfizer.