Pfizer · 2 days ago
Sr Assoc.Scientist-Assay Development
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BiotechnologyHealth Care
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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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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
Preferred
Industry experience with a focus in biotherapeutics
Good understanding or experience in the Quality Control review of work conducted in a regulated laboratory
Benefits
401(k) plan with Pfizer Matching Contributions
Pfizer Retirement Savings Contribution
Paid vacation, holiday, and personal days
Paid caregiver/parental and medical leave
Health benefits including medical, prescription drug, dental, and vision coverage
Company
Pfizer
Pfizer is a biopharmaceutical company that provides affordable access to safe, effective medicines and health care services.
Funding
Current Stage
Public CompanyTotal Funding
$31B2023-05-16Post Ipo Debt· $31B
1978-01-13IPO· nyse:PFE
Leadership Team
Recent News
2024-06-05
MarketScreener
2024-06-04
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