Bioanalyst.

Position Overview

The Bioanalyst will be responsible for developing and implementing bioanalytical assays to support clinical stage bioanalysis for candidate drugs. In this role, they will participate in the design, development, and implementation of the bioanalytical strategy for multiple oncology programs. This role reports to the Associate Director, Bioanalytical. 

Responsibilities

• Develop and implement bioanalytical assays for compounds in clinical development. This includes scientific and technical oversight of CROs performing the bioanalytical lab work as well as ensuring scientific and regulatory compliance. 

• Act as the primary contact and maintain working relationships with external vendors to facilitate execution of bioanalytical strategies.  

• Actively partner with other functions and departments to ensure that programs are progressed seamlessly through the development process; ensure bioanalytical subject matter expertise is represented in cross-functional project teams. 

• Author relevant sections of clinical study protocols, analysis plans, reports and regulatory submissions (such as IBs, CTDs, INDs, BLAs). 

Qualifications

• A minimum of 5 years' experience in pharmaceutical/biotechnology industry in a regulated bioanalytical environment, preferably with multiple modalities, including small molecules, large molecules, and ADCs. 

• A minimum of 3 years of experience managing relationships with global bioanalytical vendors (CRO’s) is required.  

• Familiarity with current global bioanalytical regulatory guidance. 

• Regulated lab experience (GLP, GCLP, ICH M10).  

• History of hands-on bench-level experience with method development, validation, and troubleshooting is required. (Ligand-binding and/or LC-MS/MS). 

Knowledge and Skills

• Demonstrated experience supporting clinical and regulatory development of bioanalytical requirements, GxP regulations, with excellent working knowledge of the regulatory process.  

• Excellent problem-solving skills and ability and desire to oversee multiple projects simultaneously in a fast-paced environment. 

• Demonstrated experience in the development and execution of bioanalytical plans to support clinical development. 

• Outstanding interpersonal and communication skills (written and oral) with ability to communicate complex information succinctly. 

• Experience authoring relevant sections of global regulatory submissions and interacting with global health authorities.  

• Ability to drive collaboration, achieve results, influence, and resolve conflicts across internal and external project teams.