Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Clinical Bioanalytics Vendor Lead
Job Description
Role Summary
As a member of the Clinical Bioanalytics (CBx) group within Clinical Pharmacology and Bioanalytics, Clinical Bioanalytics Vendor Lead will play a critical role in providing scientific and operational oversight of internal/external partners to deliver quality, timely, and regulatory compliant PK, PD bioanalytical assays, data and reports. Vendor oversight and relationship management is the foundation of CBx organizational success. It includes outsourcing strategy development and implementation, vendor selection, qualification, on-boarding and performance monitoring. Building productive partnership to ensure long-term collaborative relationship is a key measurement of success in this role.
Role Responsibilities
• Assist with the identification, screening, and qualification of bioanalytical vendors in India and other applicable regions in Asia. Contribute towards establishing CDA/MSA.
• Conduct vendor onboarding, coordinate training/re-training, monitor vendor performance through KPI tabulation and vendor visits.
• Ensure vendors adhere to regulatory guidance and industry best practices and follow predefined Pfizer SOPs, templates, and processes consistently.
• Oversee bioanalytical vendors effectively to ensure data/report quality meets Pfizer standards.
• Provide technical and compliance oversight ensuring that the assays are transferred, qualified, or validated successfully to support clinical program timelines.
• Seamlessly collaborate with internal and external stakeholders to ensure planned study deliverables are met.
• Serve as a bioanalytical SME and contribute to protocol development, implementing bioanalytical strategy and assay life cycle management.
• As an integral CBx team member, contribute to best practices, new initiatives to harmonize and enhance productivity.
• Ensure studies are appropriately budgeted, contracted and accurately invoiced.•
• Actively engage in pre-study activities including quote request, WO / lab-manual set up
• Coordinate internally to ensure sample reconciliation issues are resolved satisfactorily.
• Maintains up-to-date knowledge of current and novel chromatographic separation/mass spectrometric based detection technologies & techniques, global regulatory guidances & expectations, and industry best practices
Candidate Profile
• Bachelors with a minimum of 10 years or Masters or Ph.D degree with a minimum of 5 years bioanalytical experience in Pharma or CRO specializing in LC-MS assay development, validation, and sample analyses using. chromatographic/mass spectrometry methodologies.
• Working knowledge of GxP regulations governing conduct of clinical trials and regulatory guidances and expectations relevant to regulated bioanalysis.
• Demonstrated ability to think strategically, work in a highly matrixed environment, and execute multiple projects simultaneously.
• Highly effective verbal and written communication and presentation skills.
Additional Information
Experience : 5 - 10 years
Qualification : Bachelors or Masters or Ph.D
Location : Remote, India
Industry Type : Pharma / Healthcare / Clinical research
End Date : 10th November, 2023
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