Bioanalytical Portfolio Scientist

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $109k - $147.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Serve as the technical subject matter expert for outsourced methods • Ensure adequate method validation and optimal method performance at CROs • Provide scientific and technical oversight of outsourced bioanalytical study phases governed by GLP/GCP principles • Provide oversight of immunogenicity bioanalytical activities, including ADA and NAb assays • Lead assay transfer and validation at external CROs • Collaborate with internal bioanalytical subject matter experts on immunogenicity methods • Monitor assay performance and provide input for troubleshooting and continuous improvement • Manage the method lifecycle, including validation plans, protocols, reports, reagents, and reference materials • Review analytical data and study documentation for scientific accuracy, consistency with GLP/GCP standards, and regulatory guidance • Work with CRO cross-functional partners on issue resolution and escalation • Provide subject matter expertise during supplier evaluation and monitoring • Follow and contribute to guidance documents and SOPs • Support regulatory activities

🎯 Requirements

• Doctorate degree OR Master’s degree and 2 years of regulated scientific laboratory experience OR Bachelor’s degree and 4 years of regulated scientific laboratory experience • Demonstrated expertise in Immunoassay development, validation, and troubleshooting for ADA and NAb (cell based or non-cell based) assays • Knowledge of current regulatory expectations, industry best practices, and applicable scientific guidance • Experience working with CROs • Project and people management • Process management and planning skills • Excellent written and verbal communication skills • Project and issue management skills • Ability to collaborate, negotiate, and persuade others internally and externally • Ability to promote cooperation across the organization • Ability to drive results and deliver high-quality processes and outcomes • Ability to communicate appropriately to the situation • Sponsorship for this role is not guaranteed

🏖️ 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 • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible • Work/life balance opportunities • Career development opportunities • Financial plans with opportunities to save towards retirement or other goals