Principal Scientist, Project Toxicologist

🔥 10 minutes ago

🇺🇸 United States – Remote

💵 $152.2k - $206k / year

⏰ Full Time

🔴 Lead

🧬 Research Scientist

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Amgen

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1980

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $28.5G Post-IPO Debt on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.

📋 Description

• Provide scientific and strategic leadership for immunogenicity assay development, validation, transfer, and implementation across nonclinical and clinical programs • Serve as a senior subject-matter expert for ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assay approaches • Apply global regulatory guidance, GLP/GCP expectations, and statistical assay validation principles to guide program decisions • Lead complex data interpretation, troubleshooting, and risk assessment for immunogenicity bioanalytical strategy • Provide scientific oversight of assay transfers to CROs and lead troubleshooting while ensuring scientific quality, compliance, and timeline delivery • Collaborate with drug development teams, research groups, compliance, outsourcing teams, and senior stakeholders in a matrixed environment • Contribute to regulatory filing documents and respond to questions from regulatory review • Mentor scientists and supervise or support laboratory staff • Contribute to functional capability building, innovation, and best-practice development

🎯 Requirements

• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field [and relevant post-doc where applicable] and 3 years of scientific/technical industry experience, OR Master’s degree and 6 years of scientific/technical industry experience, OR Bachelor’s degree and 8 years of scientific/technical industry experience • Demonstrated expertise in the development, validation, and oversight of immunogenicity assays for detection of anti-drug binding and neutralizing antibodies according to current global regulatory guidelines • Experience working under Good Laboratory Practices (GLPs) and knowledge of Good Clinical Practices (GCP) guidelines • Experience transferring immunogenicity assays to bioanalytical CROs • Knowledge of statistical approaches applied to immunogenicity assays • Knowledge of drug-tolerant assay formats for ADA and NAb detection • Knowledge of cell-based assay formats for NAb detection • Knowledge of predictive immunogenicity methods using cell-based or ligand-binding methods • Supervisory and mentoring experience in a lab setting • Ability to analyze and interpret data for assay development, validation, and troubleshooting • Ability to multitask and manage multiple projects • Strong verbal and written communication skills • Previous experience working in a matrixed environment • Project management skills to meet critical timelines • Ability to collaborate with cross-functional teams while working independently

🏖️ Benefits

• 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 • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Career development opportunities • Work/life balance support