Scientist II

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Scientist II
Location: Irvine, CA
Duration: Long Term

Job Overview

We are seeking a Scientist II to perform cGMP cell-based potency assays and laboratory testing to support biologics manufacturing. The role involves bioassays, aseptic cell culture, cell banking, data analysis, laboratory documentation, and quality system activities in a regulated environment.

Key Responsibilities

• Perform cGMP cell-based potency assays to support biologics manufacturing and ensure timely completion of laboratory testing.
• Generate, compile, review, and evaluate laboratory data for technical reports supporting commercial and clinical supplies.
• Review and approve raw data, laboratory logbooks, and worksheets.
• Perform aseptic cell culture and cell banking activities.
• Manage critical laboratory reagents and supplies.
• Prepare and manage quality system records, including laboratory investigations, change controls, and non-conformances.
• Support regulatory inspections and maintain compliance with applicable requirements.
• Ensure proper use and maintenance of laboratory equipment, including equipment validation and preventive maintenance.
• Generate, revise, and maintain Standard Operating Procedures (SOPs).
• Follow cGMP, Environmental Health and Safety (EHS), and laboratory data integrity requirements.
• Maintain accurate laboratory documentation and comply with computerized system data integrity standards.

Required Qualifications

• Master's degree in Chemistry, Biochemistry, Cell Biology, or a related biological science field with 3+ years of relevant industrial experience, or a bachelor's degree in a related field with 5+ years of relevant industrial experience.
• Experience working in a cGMP-regulated environment.
• Knowledge of laboratory quality systems, investigations, change controls, and non-conformance management.
• Experience with bioassays, Chemi-ECL ELISA, PCR, and laboratory automation is preferred.
• Experience with aseptic cell culture and cell banking is preferred.
• Proficiency in Microsoft Excel and Microsoft Project.
• Strong laboratory documentation, data review, and data integrity skills.
• Ability to follow SOPs, maintain laboratory equipment, and support regulatory inspections.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.