American Regent, Inc. · 5 hours ago
Research Scientist II
Brea, CA
Full-time
Onsite
Mid Level
$91K/yr - $100K/yr
4+ years expAmerican Regent, Inc. is a company focused on pharmaceutical development, and they are seeking a Research Scientist II to execute activities related to method development and validation. The role involves conducting analytical studies, preparing samples for analysis, and ensuring compliance with regulatory guidelines.
Health CareMedical
Responsibilities
Conduct analytical studies in support of formulation development, process development, process scale-up, and regulatory filing
Organize and prepare samples for analysis by external laboratories
Develop and validate analytical methods for raw materials, in-process and finished product under cGLP/cGMP, ICH, USP/EP Guidelines
Prepare protocols and reports for method validation, analytical test methods, technology transfer, and stability studies
Provide training new scientists to perform analytical methods and instruments
Troubleshoot and maintain analytical equipment
Observe and maintain compliance, safety regulations, cGLP/GMP guidelines, and company policies and procedures
Perform any other tasks/duties as assigned by management
Qualification
Required
BS or MS degree in pharmaceutical science, chemistry, biology, or life science related field
4+ years of method development and validation experience in the pharmaceutical industry
Experience of analytical instrument techniques UV, HPLC, GC etc
Experience on analytical method development and validation for assay and impurities
Extensive experience on protocol writing, technical report creation, and lab investigations
Good working knowledge of HPLC and GC techniques and trouble shooting skills
Ability to multi-task, focus on priorities, and problem solving
Ability to work effectively within an interdisciplinary team setting (independently and collaboratively)
Good knowledge of GMP Compliance, ICH, EP / USP Guidelines
Excellent computer skills (Excel, Word, PowerPoint etc.), documentation and technique writing skills
Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves
Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision
Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly
Employee must be able to occasionally lift and/or move up to 50 pounds
Work in a lab and office environment
The employee is required to safely handle, use, and dispose of chemicals
Benefits
Healthcare
Life insurance
Profit sharing
Paid time off
Matching 401k
A wide range of other benefits
Company
American Regent, Inc.
American Regent, Inc, a Daiichi Sankyo Group Company, develops, manufactures, and supplies high quality sterile injectables for healthcare providers, clinics and hospitals across the United States and Canada.
501-1000 employees
H1B Sponsorship
American Regent, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (10)
2023 (4)
2022 (5)
2021 (8)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Paul Diolosa
President & CEO
Joseph Boyle
VP Finance / CFO
Recent News
GlobeNewswire
2026-01-09
thefly.com
2025-08-28
Company data provided by crunchbase