Scientist, Bioanalytical Sciences

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $109k - $147.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🦅 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 activities, including PK and TK analyses • Provide oversight for transfer, validation, and execution of PK assays • Lead transfer and validation of PK assays at external CROs using ligand-binding, ELISA, ECL, LC-MS/MS, and hybrid methodologies • Collaborate with internal bioanalytical subject matter experts to support assay transfer and validation • Monitor assay performance and contribute to troubleshooting and continuous improvement • Manage the method lifecycle, including review of validation plans, protocols, reports, and qualification/bridging of reagents and reference materials • Review analytical data and study documentation for scientific accuracy, GLP/GCP compliance, and regulatory alignment • Work with cross-functional CRO 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 [and relevant post-doc where applicable], OR Master’s degree and 2 years of regulated commercial scientific laboratory experience, OR Bachelor’s degree and 4 years of regulated commercial scientific laboratory experience • Demonstrated expertise in PK assay development, validation, and troubleshooting for LBA, LC-MS or hybrid assays • Knowledge of current relevant regulatory guidance/regulations, including FDA, ICH, EMEA, and NMPA • Experience working with CROs • Project and people management skills • Process management and planning skills • Excellent written and verbal communication skills • Project and issue management skills • 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 • Career development opportunities • Work/life balance support