Pfizer · 2 days ago

Sr Assoc.Scientist-Assay Development

New London County, CT

Full-time

Onsite

Senior Level

$65K/yr - $108K/yr

3+ years exp

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Responsibilities

Responsible for supporting clinical flow cytometry biomarker assay development and validation, data generation and analysis, QC and data interpretation.

Participate with BEST/CBT teams in a matrix environment.

Participate in all phases of FACS laboratory operations including technology evaluations, development of sample preparation, separation and detection methods, data analysis and interpretation.

Maintain regulatory compliance appropriate for clinical study execution including all proscribed training as found in CBT SOPs and training transcripts.

Participate in continuous improvement of scientific and regulatory processes via updating/creation of SOPs, implementation of laboratory 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 group.

Participate/respond to internal audit findings on assigned projects.

Occasional weekend work for processing clinical samples should be anticipated.

Qualification

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Immune Cell Function AnalysisPhenotypic AnalysisAssay TechniquesGlobal Regulatory RequirementsGCLPOrganizational SupportProblem-SolvingAdaptabilityCommunicationBiotherapeuticsQuality controlRegulated laboratoryAttention to detail

Required

Bachelor’s Degree or equivalent experience in chemistry, biochemistry, biology or related discipline with over 3-5 years of experience in drug development and regulatory compliance within the pharmaceutical industry

Master's Degree with 0 to 3 years of experience in drug development and regulatory compliance within the pharmaceutical industry

Experience in immune cell function and phenotypic analysis using a variety of assays

Knowledge and experience of global regulatory requirements as well as industry guidance as they relate to GCLP

Excellent oral and written communication skills

Ability to deal with project and organizational changes while supporting the organization