Senior Scientist, Translational Science

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

📋 Description

• Oversee the daily execution of outsourced bioanalytical tasks for pharmacokinetic, immunogenicity, and/or biomarker assays performed at CROs.

• Offer scientific guidance on the design, development, qualification, validation, implementation, and maintenance of bioanalytical methods in line with relevant regulatory standards and industry practices.

• Assess assay protocols, validation plans and reports, sample analysis plans and reports, and bioanalytical data packages for scientific quality, thoroughness, and data integrity.

• Collaborate with CROs and internal stakeholders to monitor milestones, communicate risks, and ensure the timely availability of necessary scopes, quotes, contracts, purchase orders, samples, and reagents.

• Organize and coordinate clinical sample analysis across various studies, considering sample availability, testing priorities, laboratory timelines, and data delivery.

• Partner with internal and external subject matter experts to troubleshoot and resolve issues during assay development, validation, or clinical sample analysis.

• Analyze bioanalytical data, identify trends and anomalies, summarize findings, and communicate results within the translation science team.

• Contribute bioanalytical content to laboratory manuals and data transfer agreements.

• Perform additional duties as required.

⛳️ Requirements

• PhD in biology, biochemistry, pharmacology, chemistry, or a related scientific field with 2+ years of applicable industry experience; or MS with 5+ years of relevant experience in regulated bioanalysis and drug development within the biotechnology or pharmaceutical industry.

• Proficiency in supporting large-molecule pharmacokinetic and immunogenicity assays, including neutralizing antibody methodologies.

• Familiarity with various bioanalytical platforms, such as LC-MS/MS, ELISA, electrochemiluminescence, ligand-binding assays, MSD, and/or multiplex assays.

• Experience in engaging and managing CROs, including the review of technical documents, data, reports, and study deliverables.

• Understanding of GLP, GCLP, data integrity principles, and relevant bioanalytical and immunogenicity regulatory requirements.

• Experience in writing or reviewing bioanalytical reports and contributing scientific content to regulatory submissions.

• Exceptional written and verbal communication abilities, sound scientific judgment, and the capacity to convey technical information to diverse audiences.

• Detail-oriented and collaborative, possessing strong organizational, prioritization, and time-management skills, along with the ability to manage multiple tasks in a fast-paced environment.

🏝️ Benefits

• Competitive market compensation and benefits package, including performance bonuses, equity grant opportunities, and health, welfare, and retirement benefits.

• Unlimited paid time off (PTO).

• Two one-week company-wide shutdowns each year.

• Commitment to your professional growth and access to resources that facilitate your development.

• Fully remote team with regular in-person meetings to foster relationships and address challenges.

• Chance to work in a fast-paced, highly dynamic environment where you can influence the culture of our emerging company, take on multiple roles, and accelerate your learning.