Bioanalytical Portfolio Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the technical subject matter expert for outsourced methodologies.

• Ensure sufficient method validation and optimal performance of methods at CROs.

• Provide scientific and technical oversight for outsourced bioanalytical study phases adhering to GLP/GCP principles.

• Oversee immunogenicity bioanalytical activities, including ADA and NAb assays.

• Lead the transfer and validation of assays at external CROs.

• Collaborate with internal bioanalytical experts on immunogenicity methodologies.

• Monitor assay performance and offer insights for troubleshooting and continuous enhancement.

• Manage the method lifecycle, which includes validation plans, protocols, reports, reagents, and reference materials.

• Review analytical data and study documentation to ensure scientific accuracy, consistency with GLP/GCP standards, and adherence to regulatory guidance.

• Work alongside CRO cross-functional partners to address issues and escalate when necessary.

• Provide subject matter expertise during supplier evaluations and ongoing monitoring.

• Follow and contribute to guidance documents and standard operating procedures (SOPs).

• Assist with regulatory activities.

⛳️ Requirements

• Doctorate degree OR Master’s degree with 2 years of regulated scientific laboratory experience OR Bachelor’s degree with 4 years of regulated scientific laboratory experience.

• Proven expertise in the development, validation, and troubleshooting of Immunoassays for ADA and NAb (both cell-based and non-cell-based) assays.

• Familiarity with current regulatory expectations, industry best practices, and relevant scientific guidance.

• Experience collaborating with CROs.

• Skills in project and personnel management.

• Proficiency in process management and planning.

• Exceptional written and verbal communication abilities.

• Competence in project and issue management.

• Ability to collaborate, negotiate, and persuade stakeholders both internally and externally.

• Capability to foster cooperation across the organization.

• Skill in driving results and delivering high-quality processes and outcomes.

• Ability to communicate effectively based on the context.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• A comprehensive employee benefits package, which includes a Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for work/life balance.

• Career development opportunities.

• Financial plans with options to save for retirement or other goals.