Scientist II

Title: Scientist II

Location: Irvine, CA

Contract Duration: 2 Years

Top Skills:

1. Gas Chromatography (GC)
2. High-Performance Liquid Chromatography (HPLC)
3. Capillary Electrophoresis (CE)
4. cGMP Laboratory Testing, Investigations, CAPA, and OOS Management
5. Laboratory Data Integrity and Regulatory Documentation

Job Summary

We are seeking a qualified Scientist II to support laboratory testing and analytical activities in a cGMP-regulated pharmaceutical environment. The ideal candidate will have hands-on experience with Gas Chromatography (GC), High-Performance Liquid Chromatography (HPLC), and Capillary Electrophoresis (CE) , along with a strong understanding of laboratory data integrity, quality systems, and regulatory compliance.

The candidate will be responsible for routine chemical and laboratory testing, investigations, CAPAs, method transfers, equipment qualification, and documentation. This role requires strong attention to detail, the ability to work independently, and flexibility to support manufacturing schedules, including overtime, weekends, holidays, and nonstandard hours as needed.

Key Responsibilities

• Perform routine chemical and laboratory testing in accordance with cGMP requirements and established procedures.
• Operate and maintain analytical instruments, including HPLC, Gas Chromatography (GC), Capillary Electrophoresis (CE), and UV analysis equipment.
• Ensure timely completion of laboratory testing, in-process sampling, and analytical activities to support manufacturing operations.
• Maintain laboratory data integrity and comply with applicable regulatory requirements for laboratory documentation and computerized systems.
• Own and support quality system records related to deviations, laboratory investigations, Corrective and Preventive Actions (CAPAs), and Out-of-Specification (OOS) results.
• Participate in method transfers, analytical method validation, and the transfer of new products as required.
• Support the qualification of new laboratory equipment and ensure instruments are used and maintained appropriately.
• Author, review, and update laboratory documents, including protocols, reports, test methods, and Standard Operating Procedures (SOPs).
• Assist in resolving laboratory quality issues and support change control activities.
• Maintain accurate, complete, and timely records of all testing and laboratory activities.
• Perform routine laboratory operations, including waste disposal, glasswasher operation, and autoclave runs.
• Maintain accurate inventory records for toxins during use and follow applicable safety and handling procedures.
• Comply with Environmental, Health, Safety, and Environmental standards, procedures, and policies.
• Work in designated Biosafety Level 2 (BSL-2) and Biosafety Level 3 (BSL-3) laboratory areas requiring authorized access to select agents and toxins, while adhering to applicable federal regulations and internal requirements.

Required Qualifications

• Bachelor’s degree in Chemistry, Biology, or another relevant scientific discipline.
• 3–5 years of hands-on laboratory experience in a pharmaceutical, biotechnology, or related regulated environment.
• Strong practical experience with HPLC and Gas Chromatography (GC).
• Working knowledge or experience with Capillary Electrophoresis (CE) and UV analytical methods.
• Experience performing routine testing and supporting laboratory investigations, deviations, CAPAs, and OOS results.
• Experience working in a cGMP-regulated laboratory environment.
• Knowledge of laboratory data integrity, documentation practices, and computerized systems compliance.
• Experience with analytical method transfers, validation, equipment qualification, and change control.
• Strong documentation, organizational, communication, and problem-solving skills.
• Ability to work independently, prioritize tasks, and manage competing deadlines while maintaining accuracy and quality.
• Ability to work overtime, weekends, holidays, and nonstandard hours based on manufacturing requirements.

Work Environment and Physical Requirements

• 100% onsite position in Irvine, California.
• Combination of laboratory and manufacturing-support environments.
• Ability to wear a respirator for at least four hours during production activities when required.
• Ability to perform regular physical activities, including lifting and carrying equipment, pushing carts, and opening doors during environmental monitoring and related laboratory activities.
• Willingness to accommodate overtime, weekend, and holiday schedules as needed.
• Ability to work in regulated laboratory areas with select agents and toxins, subject to applicable access and compliance requirements.