Senior Scientist, Bioanalytical PK/PD

Job Description

R3 Senior Scientist, PCD Outsourcing, Description: 

Our Company is a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products. 

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development. 

Employees within the group provide oversight for outsourcing of regulated clinical and preclinical assay method development, validation, and sample testing in support of biologics and small-molecule programs.  This group is seeking a dynamic and collaborative employee with established scientific experience in large and small molecule bioanalytical assay development and validation as well as general project management skills to provide oversight for bioanalytical outsourcing.   Oversight will include Pharmacokinetics (PK), Anti-Drug Antibody (ADA), and Neutralizing antibody (NAb) assays. Job responsibilities will support third party lab operational oversight and associated activities including management of assay transfer and validations, study sample analysis contracting, relationship management, meeting organization, and vendor performance to ensure quality, timeliness and compliance of outsourced bioanalytical work.    

PLEASE NOTE THAT THIS IS NOT A LABORATORY-BASED POSITION. 

Job Summary: 

Our company's Regulated PK/ADA Bioanalytical Outsourcing Group is seeking a dynamic and collaborative expert in bioanalytical method development, validation, and assay lifecycle maintenance for large and small molecules, with general project management skills. The ideal candidate will have experience in regulated bioanalytical environments, familiarity with FDA bioanalytical guidance requirements, and the ability to work both independently and within a cross-functional team. This position offers an excellent opportunity to enhance your strong technical, communication, interpersonal and teamwork skills in a fast-paced, scientifically driven environment. 

Specific Responsibilities include: 

• Relationship management of Contract Research Organizations (CROs) to support regulated PK/ADA/Nab bioanalysis across clinical and GLP studies. 

• Review and provide input on study designs, data files, bioanalytical reports, test methods, study related activities.  

• Communication of program deliverables and timelines to vendors; setting clear expectations for CRO deliverables and monitoring logistics to ensure timely completion of program deliverables. 

• Work independently and collaboratively to solve complex problems.   

• Close collaboration with Subject Matter Experts