Scientist, Bioanalytical Sciences

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

📋 Description

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

• Ensure comprehensive method validation and optimal performance at Contract Research Organizations (CROs).

• Provide scientific and technical oversight for outsourced bioanalytical tasks, including pharmacokinetics (PK) and toxicokinetics (TK) analyses.

• Supervise the transfer, validation, and implementation of PK assays.

• Lead the transfer and validation of PK assays at external CROs utilizing ligand-binding, ELISA, ECL, LC-MS/MS, and hybrid techniques.

• Collaborate with internal bioanalytical experts to facilitate assay transfer and validation processes.

• Monitor assay performance and engage in troubleshooting and continuous enhancement efforts.

• Manage the method lifecycle, which includes reviewing validation plans, protocols, reports, and the qualification/bridging of reagents and reference materials.

• Evaluate analytical data and study documentation for scientific accuracy, GLP/GCP compliance, and regulatory alignment.

• Collaborate with cross-functional CRO partners for issue resolution and escalation.

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

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

• Assist with regulatory activities.

⛳️ Requirements

• Doctorate degree [and relevant post-doctoral experience where applicable], OR a Master’s degree with 2 years of experience in a regulated commercial scientific laboratory, OR a Bachelor’s degree with 4 years of experience in a regulated commercial scientific laboratory.

• Proven expertise in PK assay development, validation, and troubleshooting for ligand-binding assays (LBA), LC-MS, or hybrid assays.

• Familiarity with current relevant regulatory guidelines and regulations, including those from the FDA, ICH, EMEA, and NMPA.

• Experience collaborating with CROs.

• Strong project and people management capabilities.

• Proficient in process management and planning.

• Exceptional written and verbal communication skills.

• Competent in project and issue management.

• Sponsorship for this position is not assured.

🏝️ Benefits

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

• Group medical, dental, and vision insurance coverage.

• Life and disability insurance options.

• Flexible spending accounts available.

• A discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off policies.

• Flexible work models where feasible.

• Opportunities for career development.

• Support for work/life balance.