Bioanalytical Portfolio Scientist

• Serve as the technical subject matter expert for outsourced methods and is responsible to ensure adequate method validation and optimal method performance at CROs
• Provides scientific and technical oversight for the transfer, validation, and execution for pharmacokinetic (PK) assays, ensuring adherence to sponsor requirements and current regulatory guidance on bioanalytical assays (e.g. FDA, ICH, EMEA, NMPA)
• Leads the transfer and validation of PK assays at external CROs using ligand-binding, ELISA, ECL, LC-MS/MS and hybrid methodologies
• Collaborates closely with internal bioanalytical subject matter experts to understand critical attributes of the PK method to ensure successful assay transfer and validation
• Monitors assay performance over time and provides input for troubleshooting and continuous improvement efforts
• Accountable for method lifecycle management, including review of method validation plans, protocols, reports, and qualification/bridging of reagents and reference material
• Reviews analytical data, method protocol, validation/sample analysis plans, reports, and other study documentation for scientific accuracy and consistency with GLP/GCP documentation standards and current regulatory guidance
• Works with cross functional partners from CROs to navigate issue resolution and escalation utilizing the governance structure
• Provides subject matter expertise during supplier evaluation and monitoring activities
• Follows and contributes to guidance documents and SOPs

Doctorate degree OR Master's degree and 2 years of regulated commercial scientific laboratory experience OR Bachelor's degree and 4 years of regulated commercial scientific laboratory experience OR Associate's degree and 8 years of regulated commercial scientific laboratory experience OR High school diploma / GED and 10 years of regulated commercial scientific laboratory experience

• Excellent communication skills
• Strong project management experience
• Fluency in English, both in written and oral communication
• Demonstrated expertise in PK assay development, validation, and troubleshooting for LBA, LC-MS or hybrid assays
• Knowledgeable on current relevant regulatory guidance/regulations (e.g. FDA, ICH, EMEA, NMPA)
• Experienced in working with CROs
• Project and people management
• Process management and planning skills
• Excellent written and verbal communication skills
• Collaborates, negotiates and persuades others, both internally and externally
• Openly promotes cooperation across the organization
• Project and issue management skills
• Drives for results
• delivers processes and outcomes of the highest quality
• Consistently communicates in a manner that is appropriate to the situation

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible